Innovations in Genetic Testing

Genetic Testing Innovations

Genetic testing is quickly becoming a cornerstone of healthcare, with new medical technologies and innovations enhancing how scientists work with genetics. Gene therapy, simplified genetic tests, and analysis of fully sequenced genomes are just some of the genetic testing innovations improving healthcare today and tomorrow.

The global genetic testing market has consistently risen over the past few years. This rise is fueled by the increasing prevalence of genetic disorders and growing awareness about the benefits of genetic testing. In fact, the global genetic testing market will likely reach 22.834 billion USD in 2024, registering 11.50 percent CAGR throughout the assessment period (2019-2024), according to Market Research Future.

Genetic testing involves a set of laboratory tests that study the patient’s genetic makeup, and identify any gene mutations or alterations in the patient’s DNA that could potentially lead to the development of genetic disorders. Healthcare professionals can use genetic tests to confirm or rule out a suspected genetic disorder. Genetic testing can also help determine the probability that an individual will develop a genetic disorder or pass one down to the next generation.

Types of Genetic Testing and Innovations

As of August 2017, there were about 10,000 unique genetic test types, and approximately 75,000 genetic tests on the market including direct-to-consumer (DTC) genetic tests like 23andMe – more are under development every year. The general types of genetic tests include:

Newborn testing – used just after birth to detect genetic disorders early, when they are easiest to treat

Diagnostic testing – identifies or rules out a specific genetic condition

Carrier testing – identifies people who carry one copy of a gene mutation that, when coupled with another gene with the same mutation, causes a genetic disorder; this test can help couples determine their risk for having a child with a genetic disorder

Prenatal testing – offered during pregnancy if there is a chance that the baby will have a genetic disorder, prenatal testing detects changes in a fetus’s genes prior to birth

Pre-implantation testing – used to detect changes in embryos created through in-vitro fertilization or other assisted reproductive technology to reduce the risk of having a child with a specific genetic disorder

Predictive and presymptomatic testing – detect gene mutations associated with conditions that develop after birth or even later in life; helpful for people whose family member has a genetic condition, but who have no signs or symptoms of the condition at the time of testing

Forensic testing – uses DNA sequences to identify someone for legal purposes, such as identifying victims of a crime or catastrophe, rule out or implicate a suspect in a crime, or to establish paternity or other biological relationship

Genetic Testing Delivery Systems

Innovations in genetic testing involve new delivery systems, finding new genetic variants, and finding new uses for genetic therapies. Researchers from Fred Hutchinson Cancer Research Center recently started using gold nanoparticles as a scalable delivery vehicle for their CRISPR systems, for example, instead of the “old fashioned” approach of using electric shock or viral vectors to deliver genetic editing tools to DNA.

Another group of researchers analyzed coding genes from nearly 46,000 people to identify four genes that contained rare genetic deviations linked to type 2 diabetes. Pharmaceutical companies could use these genes and the proteins they encode as targets for new diabetes medications and treatments.

Doctors in the United States have begun using CRISPR gene-editing therapy to treat cancer patients for the first time. The University of Pennsylvania is following the first two patients in the country to undergo the new therapy – one with sarcoma and one with multiple myeloma, whose cancers did not respond to conventional treatment.

Genetic testing could even help scientists understand COVID-19; they currently use genetic testing known as RNA or PCR tests, to detect the disease.

genetic testing and innovations clinical trials

The tsunami of gene therapy clinical trials underway right now will create a flood of data, particularly in oncology. Oncology is an area that currently represents a quarter of Phase I and Phase II trials. Much of the push to expand genetic testing will come from the consumers themselves. Patients are currently pushing to expand genetic testing beyond its current confines of rare diseases to cover common conditions, such as Parkinson’s disease. In cases in which insurance does not cover the costs of these tests, patients may seek to enroll in clinical trials. When genetic testing is not affordable or accessible, consumers will turn to at-home genetic testing.

FRANK MAGLIOCHETTI

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Last year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Frank is also CEO of ClickStream, ClickStream’s business operations are focused on the development and implementation of WinQuik™, a free to play synchronized mobile app and digital gaming platform. The platform is designed to enable WinQuik™ users to have fun, interact and compete against each other in order to win real money and prizes. Twitter at @ClickstreamC and @WinQuikApp.

Genetic Industry

Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.

Frank Magliochetti News is developing Genetic Innovation News.com the site is devoted to genetic innovations; we encourage contributors – the site wants to broadcast your news, discoveries,and innovations.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.marketresearchfuture.com/reports/genetic-testing-market-2009

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987210

https://www.genome.gov/dna-day/15-ways/direct-to-consumer-genomic-testing

https://www.23andme.com/

https://ghr.nlm.nih.gov/primer/testing/uses

https://www.nature.com/articles/s41563-019-0385-5

https://www.nature.com/articles/s41586-019-1231-2

https://www.the-scientist.com/news-opinion/sars-cov-2-spike-protein-shares-sequence-with-a-human-protein-67596

https://asm.org/Articles/2020/April/COVID-19-Testing-FAQs

https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/gene-therapy-coming-of-age-opportunities-and-challenges-to-getting-ahead

Hereditary Cancer Testing: Prostate Cancer

Prostate cancer is the second leading cause of cancer death in men in the United States, behind only lung cancer, according to the American Cancer Society. Cancer of the prostate is a serious disease, but most men diagnosed with prostate cancer do not die from it – early detection and personalized treatment saves lives. Doctors currently use tests, such as prostate-specific antigen (PSA), to detect and diagnose prostate cancer, but hereditary cancer screening may hold the key to earlier diagnosis and more effective treatment.

Hereditary Cancer Testing

Some people inherit a genetic mutation from their mother or father. This damaged gene puts them at greater risk for developing certain forms of cancer, including prostate cancer. In fact, hereditary prostate cancer accounts for 5 to 10 percent of all prostate cancer. Having a brother or father with prostate cancer more than doubles a man’s risk for having the disease. Hereditary cancer testing helps men understand their inherited risk of developing cancer within their lifetime. This type of testing can also help reduce or eliminate unnecessary prostate biopsies completely in men suspected of having prostate cancer.

Hereditary cancer testing works by looking for specific changes, or mutations, in specific genes, chromosomes, and proteins. These mutations can change the way the gene works; in some cases, gene mutations can cause the uncontrolled growth of abnormal cells that characterize cancer.

Most commonly, hereditary cancer testing for prostate cancer looks for mutations in BRCA2 and BRCA1 genes, and in other genes associated with prostate cancer.

Hereditary Cancer Testing is Gaining Traction as a Way to Provide Earlier Diagnosis and More Effective Treatment for Prostate Cancer

While hereditary cancer testing can help inform treatment and management approaches to prostate cancer, genetic testing of men for prostate cancer is relatively uncommon, largely because of inconsistent guidelines covering the testing and challenges in implementing genetic counseling services. There is a lot of confusion regarding when men should undergo hereditary testing for prostate cancer, the genes that should be tested, understanding the impact genetic results will have on personalized treatment programs, and the effect hereditary testing for prostate cancer can have for men and their families.

Healthcare professionals and genetic testing companies are working hard to change that, though, and are making advances to bring hereditary cancer testing for prostate cancer to the men who need it. A group of healthcare professionals recently published key recommendations in Journal of Clinical Oncology, for example. The group, made of oncology, urology, genetic counseling, primary care, and Veterans Affairs experts along with patient stakeholders, strongly endorsed genetic testing in men with metastatic (spreading) prostate cancer to help guide treatment and to determine the patient’s eligibility in clinical trials. They also recommended this type of testing to screen men whose family history suggests an increased risk of prostate cancer and other types of cancer.  

 The researchers also addressed the impact hereditary cancer testing can have on the treatment of prostate cancer in its early stages. The group recommended BRCA-2 testing for screening and for helping men and their doctors make decisions about treating early-stage prostate cancer.

The researchers also reviewed cancer screening strategies, such as the age men should begin screening for prostate cancer and which genes to test. The group recommended testing BRCA2 and another gene, HOXB13, for screening and early detection. Furthermore, the panel recommended that BRCA2 carriers begin PSA testing early; doctors may recommend early screenings beginning at age 40 or about 10 years prior to the youngest prostate cancer diagnosis in the patient’s family.

Because hereditary testing may uncover inherited cancer risk, the researchers also discussed genetic testing for both male and female relatives of those men who test positive for genetic mutations, depending on the patient’s family history of cancer and other factors.

Hereditary cancer testing for prostate cancer is growing increasingly common because of the important role it plays in the screening, diagnosis and treatment of prostate cancer.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Last year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment. Most recently; Frank was appointed Chairman and Chief Executive Officer at Designer Genomics International, Inc. The Company has accumulated a growing body of evidence that highlights a link between alterations in the immune and inflammatory systems and the development of chronic human disease. The Company is visionary and has established itself as a leader in the field of inflammatory and immune genetic DNA and RNA biomarkers that play a causative role in debilitating conditions, such as atherosclerosis/heart disease, diabetes, arthritis, inflammatory bowel disease, post-traumatic stress disorders (PTSD) and cancer.
A proprietary state-of-the art data mining bioinformatics program, called ‘cluster analysis’ will be used to measure disease development susceptibility with potential for earlier diagnosis and intervention. The company is developing a healthcare program based on its proprietary genetic panels that will allow people to be their own healthcare advocate and take an active role in their health status as well as longevity.

This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Sources

https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html#:~:text=Deaths%20from%20prostate%20cancer,do%20not%20die%20from%20it.

https://www.mskcc.org/cancer-care/risk-assessment-screening/hereditary-genetics/genetic-counseling/inherited-risk-prostate

https://www.cancer.org/cancer/prostate-cancer/causes-risks-prevention/risk-factors.html

https://ascopubs.org/doi/10.1200/JCO.20.00046

Autoimmune Disease, Inflammation & COVID-19

People with autoimmune disease face a number of challenges – their condition can cause pain, skin problems, digestive issues, weakness, muscle aches, stiff joints, and more. Autoimmune diseases and their treatments can weaken immune systems to leave patients vulnerable to infections. These conditions can also cause inflammation around the body, and even in vital organs, such as the lungs. In patients with COVID-19, an unhealthy immune response can damage the lungs to cause serious complications, including severe breathing problems.

Autoimmune Diseases and Inflammation

The immune system protects the body from disease and infection. In people with autoimmune disorders, though, the immune system can attack healthy body cells by mistake. There are more than 80 types of autoimmune diseases, according to the National Library of Medicine. Autoimmune diseases include rheumatoid arthritis, psoriasis, inflammatory bowel disease, lupus, Sjogren’s disease, multiple sclerosis, Hashimoto’s disease, Celiac disease and type 1 diabetes.
Some autoimmune diseases target just one organ, such the pancreas; other autoimmune conditions affect the entire body. Many of autoimmune diseases share similar symptoms. A large number of autoimmune conditions cause inflammation, characterized by redness, heat, pain and swelling. In fact, inflammation is the classic sign of an autoimmune disease.

COVID-19 and Inflammation

The virus, known as SARS-CoV-2 or simply “coronavirus,” causes a wide variety of symptoms associated with COVID-19 disease. Most notably, the virus causes cough, fever, and shortness of breath. Coronavirus is highly contagious, already infecting at least 2 million people in the United States by the middle of June 2020, and claiming the lives of 113,000. While people with autoimmune disorders are not more likely to contract coronavirus than are the rest of the general population, they are more likely to develop severe complications if they do contract COVID-19 if they have a suppressed immune system due to their autoimmune disease or treatment for their autoimmune disorder. One of the most serious complications of COVID-19 is severe inflammation throughout the body, including the lungs, heart and brain. The body reacts to the presence of the SARS-CoV-2 virus with a robust inflammatory response; health professionals now regard this excessive inflammatory response as a hallmark symptom of COVID-19.
The excessive immune response triggered by SARS-CoV-2 can cause hyper-inflammation of the lungs and of other organs. Severe inflammation of the lungs can prevent the proper exchange of oxygen and carbon dioxide, which makes it difficult for patients to get the oxygen they need.

How Autoimmune Diseases Cause Inflammation

Special receptors cover the exterior surface of body cells. Proteins bind to these receptors to change the way the cell works. A specific type of protein, known as cytokines, binds to certain receptors to regulate the body’s immune response. Cytokines are mediators, which mean they trigger and control a body response. Specifically, cytokines mediate the inflammation response to tissue injury or infection. In other words, cytokines promote inflammation as a response to tissue injury or infection. There are several types of cytokines, and each type can work alone, work together, or work against each other to regulate the immune response. A special type of cytokine, known as interleukin or IL, may play an important role in the immune response in COVID-19 patients. There are 40 interleukins, IL-1 through IL-40, and each performs a function. Interleukins normally help the immune system fight off viruses and bacteria in the body, but an overactive immune system can cause interleukins to attack the body instead. This can lead to chronic inflammatory conditions.
In a significant physiological event, known as a cytokine storm, can cause the release of a flood of interleukin that leads to widespread and dangerous inflammation. Research shows that COVID-19 can cause a cytokine storm that releases IL-6, IL-1, IL-12, and IL-18. The excessive number of cytokines can damage tissue and could lead to the breakdown of the protective lining in the lungs and blood vessels. The breakdown and weakening of this protective lining can allow fluid and proteins to leak from blood vessels and into the tiny air sacs of the lungs. This fluid displaces air, which prevents the air sacs from filling with oxygen. The resulting lack of oxygen causes the patient to experience shortness of breath, and puts the patient at a higher risk for complications and a more severe case of COVID-19. Inflammation related to autoimmune disease can have serious consequences for patients. This is especially true for those who contract COVID-19. To View Frank Magliochetti Press Releases Please CLICK HERE Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.
This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg
Mr. Frank Magliochetti MBA Managing Partner Parcae Capital www.parcaecapitalcorp.com www.frankmagliochetti.com

SOURCES:

https://medlineplus.gov/autoimmunediseases.htmlhttps://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.htmlhttps://www.ncbi.nlm.nih.gov/books/NBK499840/https://www.medscape.com/answers/2500114-197455/what-is-the-role-of-interleukin-il-inhibitors-in-the-treatment-of-coronavirus-disease-2019-covid-19

Managing Lab Protocols and the Pursuit of a Vaccine during the Covid-19 Outbreak

Vaccine Pursuit and Managing Lab Protocols during the Covid-19 Pandemic

On April 22, 2020, the Director-General of the World Health Organization (WHO) said, “To be clear, WHO’s advice is to find and test every suspected case, not every person in a population.”

While testing every person is not essential to controlling COVID-19, finding and testing every suspected case is. As the COVID-19 outbreak sweeps across the globe, the world turns to laboratories for answers. Laboratory scientists are responding by providing doctors with ways to diagnose COVID-19 and by pursuing the development of a vaccine that could someday stop the pandemic in its tracks. Until a vaccine is found, social distancing and testing are the best ways to control the spread of the disease.

The 2019 novel coronavirus, now named SARS-CoV-2, has sickened millions of people with COVID-19. By the end of April 2020, the United States had by far the highest number of confirmed cases and deaths in the world, according to Johns Hopkins University.

Testing is the only way to determine the case fatality rate (CFR), which is the ratio between confirmed deaths and confirmed cases. Testing is also the best way to assess the overall effectiveness of preventive measures and vaccines. Determining the CFR requires time and reliable data to confirm cases and deaths based on trusted laboratory testing. Strict adherence to proven and accepted laboratory protocols provides the most accurate data possible.

Managing Laboratory Protocols during the COVID-19 Outbreak

Managing laboratory protocols during the SARS-CoV-2 outbreak is challenging because, as with the outbreak of any novel virus, researchers are entering uncharted territories. Virologists had a limited understanding of transmission patterns, clinical features, severity, and risk factors for COVID-19 infection at the start of the pandemic. To address those unknowns, WHO established Four Early Investigation Protocols, which are now known as the WHO Unity Studies.

The protocols rapidly and systematically collect and store data that will be critical in refining recommendations for case definition and surveillance, and for characterizing the key epidemiological features of COVID-19. The protocols will also help the medical community gain a greater understanding of the spread, severity and spectrum of the disease, as well as its impact on the community. Information gained from the data will help guide countermeasures, such as case isolation and contact tracing.

Rapid detection of COVID-19 cases is essential for controlling the emergence of this rapidly spreading illness and for understanding the key epidemiological features of the disease, but rapid detection requires wide availability of diagnostic testing.

Within a month of the first outbreak in China, the Centers for Disease Control and Prevention (CDC) developed a real time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) test that can diagnose COVID-19. The CDC provides instructions for the use of real-time rT-PCR assays for the in vitro qualitative detection of coronavirus in sera and respiratory specimens. FIND also maintains a list of SARS-CoV-2 tests in development or commercially available for COVID-19, and WHO maintains a list of COVID-19 in-house PCR protocols assays.

Challenges of managing laboratory protocols

Even with reliable assays, managing laboratory protocols during COVID-19 is challenging. The pandemic has disrupted the supply chain for many laboratories, for example. Personal protection equipment (PPE) is scarce, for example, and there have been shortages of SARS-CoV-2 PCR reagents.

Biosafety is also a major concern, as keeping lab workers safe is a high priority. The CDC has released biosafety guidelines for labs working with Coronavirus: Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). These guidelines include essential information on virus isolation, waste management, and decontamination. The EPA also released an expanded COVID-19 disinfectant list on March 13, 2020, but social distancing is far more effective than disinfection for controlling viral transmission. Unfortunately, social distancing is much more difficult than disinfection in a typical laboratory, where technicians work side by side and in close proximity to specimens.

While the protocols are far from perfect, and disruptions in the supply chain can slow testing, laboratory protocols will continue to play an important role in preventing the spread of COVID-19 until a vaccine is found.

Pursuit of a COVID-19 Vaccine

The best way to defeat COVID-19 is to develop a vaccine, of course, but vaccine development can often take 10 to 15 years. Vaccines for respiratory viruses are also elusive. Two toddlers died in 1966 from respiratory syncytial virus (RSV), for example, and vaccines for the parainfluenza viruses (PIVs) and metapneumovirus (MPVs) are still not available.

There are 120 projects working towards a vaccine; only five have received approval for clinical trials in humans. University of Oxford researchers began Phase I human trials of ChAdOx1 nCoV-19 in late April. In this trial, half of the roughly 1100 participants receive ChAdOx1 nCoV-19 vaccine, while the control group receives the common meningitis vaccine, MenACWY. The first two volunteers, one from the test group and one from the control, received their inoculations on April 23, 2020.

Fast tracking the development of this vaccine or others could potentially save thousands or millions of lives, providing the vaccine undergoes sufficient testing to ensure its safety and efficacy. It is possible to get a licensed vaccine in one and a half to two years, and even possible to get a vaccine into use much sooner. Reliable laboratory testing will help researchers determine if their vaccines are working.

Many of the battles against the COVID-19 outbreak will be fought in laboratories in the United States and around the world. Widespread testing will play an important role in reducing deaths associated with coronavirus and improving the health and well-being of people across the globe.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

This image has an empty alt attribute; its file name is GRACE-HEALTH-TECHNOLOGY_Frank-MAgliochetti.jpg

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

SOURCES:

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19–22-april-2020

https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19–22-april-2020

https://coronavirus.jhu.edu/map.htmlhttps://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/early-investigations

https://www.cdc.gov/coronavirus/2019-ncov/lab/index.htmlhttps://www.finddx.org/covid-19-2/pipeline/

https://www.who.int/docs/default-source/coronaviruse/whoinhouseassays.pdf?sfvrsn=de3a76aa_2

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Fhealthcare-supply-ppe.html

https://asm.org/Articles/Policy/2020/March/ASM-Expresses-Concern-about-Test-Reagent-Shortageshttps://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.htmlhttps://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2

https://www.labconscious.com/blog/2020/3/17/laboratory-sustainablity-in-the-coronavirus-crisishttps://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

https://cvi.asm.org/content/23/3/189https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547785

https://www.cbsnews.com/news/coronavirus-vaccine-covid-19-human-clinical-trial-oxford-england/

http://www.ox.ac.uk/news/2020-04-23-oxford-covid-19-vaccine-begins-human-trial-stagehttps://www.drugbank.ca/drugs/DB15656

Laboratory Management Systems – Level of Importance

Importance of Laboratory Management Systems

The need for more elaborate and accurate laboratory management systems is becoming more and more important as the scale of research and development continues to escalate.   Laboratories have been among the heaviest users of information technology since its inception more than 30 years ago. As places where questions are answered and breakthroughs begin, labs have played a defining role in defining and developing information management systems along the way.

The global laboratory information management systems (LIMS) market is growing rapidly. In fact, the research and consulting group, Acumen, anticipates the LIMS market size will around USD 2.4 billion by 2026, with 9.3% CAGR during the forecast time period. Technical advancements in pharmaceutical labs and the increasing need for laboratory automation will likely be the primary drivers behind this growth.

Biotechnological and pharma organizations are investing in research and development, which rely on sophisticated and scalable laboratory management systems for effective management and security, tracking data, patient demographics, billing, and more. To support the explosive growth of research and development, today’s laboratory management systems will need to evolve and grow.

The Evolution of Laboratory Management Systems
Information technology is the glue that holds the laboratory – and modern medicine – together. IT can compress the time and distance separating the lab from the patients and physicians. Laboratory information systems move information from place to place, seamlessly and instantaneously, to put information in the hands of doctors, patients, and interoperating businesses participating in the care, when they need it the most.

Most clinical labs once used laboratory information systems (LIS) to simplify administration and instrumentation tasks, and use laboratory information management systems to make collection, storage, and distribution of patient test results and other data easier. Many labs are now using full-service integrated systems that combine LIS and LIMS functions.

Simply combining several small lab management programs together will not be enough. Today’s LIMS must have advanced features that reduce or eliminate human error, improve real time tracking and time saving, increased revenue, and reduced workload and stress within the lab.

Tomorrow’s lab management systems will build upon today’s technologies, such as the ability to track samples in real time and unique auto-authorization feature that automatically approves reports with normal values. Modern lab solutions allow labs to manage logistics efficiently; assigning barcodes to samples at the collection station and notifying the processing center of the sample collection allows the lab to allocate resources, reagents and material even before the samples reach the processing center.

The next generation of laboratory management systems must be powerful and flexible enough to keep up with the evolving sophistication and specialization of clinical labs and their demands for advanced IT capabilities. Labs are increasing their use of molecular diagnostics, such as next-generation sequencing (NGS) systems that can create terabytes of patient data and analyses in the blink of an eye and other processes, which require a new approach to IT. Labs are also ratcheting up their ability to handle other emerging technologies, such as digital pathology, which present their own heavy-duty imaging storage and analytical processing challenges. Finally, lab management systems must evolve to handle the oncoming tsunami of data resulting from the push towards personalized medicine.

The rapid evolution of IT in healthcare creates an unparalleled opportunity to develop new, advanced laboratory management systems that can handle more data, save more money, and serve even more laboratory clients. The new systems will evolve to handle assay data management, data mining, data analysis, electronic laboratory notebook (ELN) and more.  Lab management systems that do not evolve may become outdated in their prime.

From introducing groundbreaking products to reducing waste and improving sustainability, laboratories are changing the face of research and clinical medicine. Innovations in laboratory management helps labs maintain their forward momentum in the ever-changing world of medical technology.

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Source: https://www.acumenresearchandconsulting.com/laboratory-information-management-system-market

Radical Changes in Store for Structure of the Healthcare Industry

The Structure of the Healthcare Industry will Change Radically

The healthcare industry is changing at a blistering pace. Healthcare policies, technologies, insurance coverage, and the new focus on patient experience have triggered the evolution of healthcare into something yesterday’s providers would never recognize. And, chances are, the healthcare of tomorrow will look drastically different than the care provided today.

Change had come slowly to healthcare industry legislation in the nation’s early years. The first attempt at national health insurance came about in 1905, with the formation of the American Association for Labor Legislation; Speaker of the House Thaddeus Sweet vetoed the bill. The next major change in the healthcare industry didn’t come along until 1965 when, after 20 years of heated debate in Congress, President Lyndon B. Johnson initiated legislation introducing Medicare and Medicaid. The 2010 Patient Protection and Affordable Care Act was the last major healthcare legislation.

While changes to healthcare law and healthcare insurance had came slowly, the nation’s demographics and need for medical care is now changing rapidly. Furthermore, advances in research and medical technology have fueled an astonishing metamorphosis in healthcare.

Factors Contributing to the Changing Landscape of Healthcare

Perhaps the most notable change in healthcare is its explosive growth: healthcare became the largest employer in the United States in the third quarter of 2018, according to The Atlantic.

The nation’s aging population is a major driver of the healthcare job boom. By the year 2025, one-quarter of the workforce will be older than 55. By 2030, more than 170 million people in the United States will have at least one chronic health condition, according to the American Hospital Association (AHA). The rising population of older adults, and the increasing number of people with chronic illnesses, will require a growing pool of healthcare workers. In fact, the U.S. Bureau of Labor Statistics (BLS) expects jobs in the healthcare industry to account for a large share of new jobs created through 2026.

Other factors, including the health insurance market and healthcare regulation, will affect the structure of the healthcare industry. About half of the privately insured are covered under self-insured plans, which can vary dramatically.

The healthcare system is also moving towards a financial model based on value, rather than on volume. This shift will change the focus from treating diseases in hospitals to keeping patients healthy and out of the hospital.

Expect Monumental Changes in the Healthcare Industry

To handle these changes, the structure of the healthcare industry will undergo radical transformation in a number of areas, from insurance to the makeup of the board and the role of clinicians in leading renovations within an organization.

Provider organizations offering insurance products will likely experience substantial restructuring because they are essentially creating new businesses in a highly volatile market. In fact, several health systems have already introduced health plans in recent years, according to the Healthcare Financial Management Association.

Organizations without such products are restructuring, creating regionally focused, value-based care teams and enhancing consumer engagement. Moving towards a value-based system requires increased collaboration between health systems and health plans, the implementation of patient-centric technology, increased adoption of virtual care options, and a greater focus on public health. It also requires greater understanding of patient motivation and behavior, so many healthcare organizations will restructure to include patient experience departments.

Changes in organizational structures will manifest themselves in a number of ways. Evolution of an organization’s structure may include centralization and professionalization of the board to look more like boards in other industries, for example. This shift allows senior business leaders with niche expertise to guide healthcare organizations through insurance, risk management, IT, consumer engagement, investments and capital allocation.

Many healthcare organizations are putting physicians in leadership roles, asking their clinicians to lead clinical informatics, care model transformation, and population health management initiatives. In this way, the Chief Medical Officer (CMO) is evolving into the role of Chief Transformation Officer.

While it is nearly impossible to predict where the healthcare industry will be at the end of the 21st Century, it is safe to say that healthcare in the United States will undergo more changes in the next 80 years than it has in the entire history of the nation.

SOURCES:

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Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Is Healthcare Becoming an IT Business?

Healthcare is Becoming an Information Technology Business

Frank Magliochetti declares that; Health information technology now plays an important role in patient care, payment and research, but it wasn’t always this way. Today’s health information technology represents an evolution in record keeping within the healthcare industry. In 1924, the American College of Surgeons adopted the Minimum Standard Document to ensure the recording of a complete case record that included identifying data, chief complaint, personal and family history, physical examinations, laboratory results and x-rays.

In the 20th Century, those records were written by hand and paper copies were generally stored on or offsite, unless required for a hospitalization, doctor visit or research. Sharing patient information with even one consultant or payer typically meant long hours at the copying machine to create thick envelopes filled with data that could take a substantial amount of time to sort; sharing only pertinent information with multiple parties was next to impossible.

Computers and the internet heralded the information age and electronic health records (EHR), which allowed the mass sharing and analysis of data in an instant and without cumbersome and costly paper. In 2004, President George W. Bush created the Office of the National Coordinator (ONC), which now synchronizes HIT in the U.S. healthcare sector. Passed as part of the larger American Recovery and Reinvestment Act of 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act created incentives to use health care information technology.

Each of these events paved the way to today’s already robust and rapidly growing information technology business. HITECH seems to have worked – as of 2017, 86 percent of office-based physicians had adopted an EHR and 96 percent of all non-federal, acute care hospitals had a certified health IT department or person, according to the Office of the National Coordinator for Health Information Technology.

Today’s HIT Business

To meet the growing demand on the clinical side, hundreds of healthcare IT software and service companies have sprung up across the country. Healthcare IT Skills lists more than 350 such companies, including EHRs, consulting firms, medical device providers, population health, revenue cycle management, analytics, and more.

Healthcare information technology (HIT) merges electronic systems with healthcare to store, share and analyze patient information. The advanced technology also integrates with practice management software to improve office functions that lead to better patient care. HIT now features patient portals that provides patients with access to their medical history, allows them to make appointments, message their practitioner, view bills and even pay bills online. HIT also includes features to make practitioners’ lives easier, such as ePrescribing, remote patient monitoring, and master patient indexes (MPIs) that connects patient databases with more than one database, which allows different departments within a facility to share all of the data simultaneously. MPIs reduce the need for manual duplication of patient records for filling out claims and decrease errors involving patient information, which can result in fewer patient claim denials.

As with any disruptive technology, healthcare information technology has its drawbacks and its critics. Some complain that EHRs have led to practitioners spending more time sitting in front of a computer than talk with patients. Others bemoan the cumbersome federal regulations involved. The benefits of HIT, however far outweigh its downsides.

Advantages of today’s health information technology include the ability to use big data and data analytics to manage population health manage programs effectively, for example, which is impossible with old-fashioned paper records. HIT can use data and analytics to reduce the incidence of expensive and debilitating chronic health conditions, use cognitive computing and analytics to perform precision medicine (PM) tailored to each patient’s needs, and create a means by which academic researchers to share data in hopes of developing new medical therapies and drugs. Lastly, health information technology allows patients to obtain and use their own health data, and to collaborate more fully in their own care with doctors.

Tomorrow’s HIT companies will use artificial intelligence (AI), virtual simulations, and other emerging technologies to further enhance and improve healthcare. Technologies will include digital insurance markets, price transparency tools, cloud storage that will render costly and insecure data centers obsolete, self-serve mobile applications that will eliminate forms and faxes, and centralized clearinghouses that share information across organizations and state lines. Many of these HIT applications will improve labor productivity and, given the fact that wages account for 56 percent of all healthcare spending, improvements in this area could generate significant economic gains.

Information technology will undoubtedly continue in its growth as an important and increasingly essential part of healthcare. The benefits of HIT will also continue to expand, as researchers, doctors, patients and healthcare companies integrate healthcare information technology into their everyday lives and standard business practices

To View Frank Magliochetti Press Releases Please CLICK HERE

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Can CRISPR Curb Sickle Cell?

CRISPR Has the Potential to Snip Out Sickle Cell Disease

Sickle cell disease affects about 100,000 people in the United States, according to the Centers for Disease Control and Prevention (CDC), and affects millions of people across the globe. A new technology, known as CRISPR, may change all that.

CRISPR is short for “clustered regularly interspaced short palindromic repeats.” It is a group of technologies capable of editing the genes in people with inherited conditions, such as sickle cell disease.

Sickle cell disease is an inherited disorder that affects red blood cells, which transport oxygen to the rest of the body. Specifically, sickle cell disorders affect hemoglobin (Hgb), which is the protein in red blood cells responsible for transporting oxygen. A mutation in a single DNA letter (S) causes the sickle cell trait to be passed from one generation to the next. People with sickle cell disorders inherit an abnormal version of hemoglobin, known as Hgb S, which distorts the shape of the red blood cells.

Red blood cells normally have a round donut shape that allows them to carry an ample supply of oxygen, and to flow through tiny blood vessels smoothly. People with sickle cell inherit a trait that, during a sickle cell crisis, causes the normally round blood cells to resemble the C-shaped farm tool known as a sickle. The sickle cells become hard and sticky, so they clump together instead of flowing freely.

The cells are fragile and prone to rupturing, which can lead to anemia. The deformed cells also die early, which causes a constant shortage of red blood cells. The abnormal shape also means the cells can block blood vessels and damage tissue. This can cause pain, infections, a lung problem known as acute chest syndrome, stroke and other serious health issues during a sickle cell crisis and afterwards.

Current treatments involve blood transfusions, the drug hydroxyurea and bone marrow transplants. Each of these comes with risks and complications.

Enter CRISPR

CRISPR is a group of gene editing technologies that allow scientists to change an organisms DNA by adding, removing or altering specific locations within the gene. Researchers created CRISPR by adapting a naturally occurring gene editing system in bacteria, which captures little snippets of an invading virus’s genes. If the virus ever attacks again, the bacteria use the snippets to create and insert a new DNA sequence into the virus, which effectively changes the virus.

The technology works the same in the lab, except to produce positive results. Scientists first remove the snippet of the “bad” gene that causes sickle cell, using CRISPR to cut the sickle cell gene (S) from a precise location in DNA, and replaces it with healthy genes. Scientists then attach healthy hemoglobin genes to a harmless virus, and then put the virus and the corrected genes it carries back in the patient’s body.

Researchers from the National Institutes of Health performed a clinical trial in which they used CRISPR to edit the genes of nine people with sickle cell disease. The lead researcher, John Tisdale, spoke about their progress and said that all of the people who had received the gene therapy had good hemoglobin levels and that none of the participants had experienced sickle cell crises.

More research is necessary before gene editing becomes a common course of treatment, but CRISPR may someday help all people overcome sickle cell disease and its complications.

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Pharmacogenomic Testing and Health Care Costs

Pharmacogenomic Testing: Could it Reduce Health Care Cost?

A relatively new type of drug testing could reduce health care costs. This type of testing is known as pharmacogenomic testing. It looks at how the genes a person inherits affects how medications works in his or her body.

Many things can affect how drugs work in the body. Someone’s size can be a factor, for example, as a large person needs more of a drug than does a small person. A person’s diet can also affect how well his or her body absorbs and uses medications.

Genes can also affect how a person’s body responds to drugs. Differences in genetic makeup between people influences what their bodies do to a drug and what a drug does to their bodies. A person’s genetic makeup may cause slow metabolism of medications, for example, and this can cause the drugs to accumulate to toxic levels in the body. Other people metabolize drugs so quickly that drug levels never get high enough to provide a therapeutic effect.

About Pharmacogenomics

In pharmacogenomics, scientists study the genetic differences that affect the response to drugs. The word “pharmacogenomics” is a combination of the word’s pharmacology and genomics; pharmacology is the study of the uses and effects of medications, while genomics is the study of genes and their functions. The aim of pharmacogenomics is to develop safe, effective medications and doses tailored to an individual’s genetic makeup.

Pharmacogenomic testing helps researchers get a better understanding of the relationship between genetics and drug response. This understanding ultimately leads to treatments that work better and cost less.

Most of the medications currently available are “one size fits all,” but these drugs do not work the same way for everybody due to genetic differences. These inherited differences can make it difficult to predict who will benefit from a drug, who will not respond at all, and who will suffer negative side effects. Incorrect predictions can lead to prescribing drugs that do not work, work poorly, or worst of all, cause adverse side effects.

The Food and Drug Administration (FDA) tracks adverse drug reactions and issues “black box warnings” for medications that have the potential for severe side effects associated with genetic predispositions and other causes. These warnings, which apply to more than 200 drugs, help doctors choose the right medications. In some cases, the black box warnings contain genomic information that alerts doctors to the potential risk of adverse reactions and provides dosing instructions according to pharmacogenomic testing results.

Pharmacogenomic testing can reduce health care costs by helping doctors prescribe medications that those patients who are genetically predisposed to benefiting from the drug. This testing can also reduces the risk of adverse events in patients with a certain genetic predisposition.

Negative side effects, also known as adverse drug reactions or adverse drug events, are a significant cause of hospitalizations and death. Adverse drug reactions lead to approximately 1.3 million emergency department (ED) visits and 350,000 hospitalizations every year, according to the Centers for Disease Control and Prevention (CDC). The FDA says that adverse drug events may be the fourth leading cause of death in the United States, causing more than 106,000 deaths annually.

Adverse drug reactions are dangerous, but they are also costly. Adverse drug events cost the nation about $3.5 billion in excess medical costs every year. These drug reactions affect about 2 million hospitalizations each year and prolong these hospital stays by 1.7 to 4.6 days, which significantly adds to the cost of hospital care. Outside the hospital, adverse drug reactions result in more than 3.5 million visits to doctor offices, approximately a million emergency department visits and around 125,000 admissions to the hospital. More than 40 percent of the costs related to adverse drug reactions occurring outside the hospital may be preventable.

About Pharmacogenomic Testing and its Benefits

Researchers are using information from the Human Genome Project to investigate how genetics affects the body’s response to medications. The results help researchers to predict whether a drug will work effectively for a particular person, and to help prevent adverse drug events.

The test requires a small blood or saliva sample. Laboratory technicians perform tests that look for changes or variants in one or more genes, which can affect your body’s response to certain medications.

Pharmacogenomic testing evaluates the genetic factors that affect how your body metabolizes medications. The information gained from the test helps your doctor determine if a particular medication is right for you, calculate the correct dosage to adjust for your metabolism, and to help predict whether you could experience serious side effects from the drug. It can also save money.


Medical and finance expert Frank Magliochetti explains;

Healthcare spending in the United States reached $3.5 trillion in 2017, rising by 3.9% year-on-year and accounting for 17.9% of gross domestic product (GDP), according to data from the Centers for Medicare and Medicaid Services (CMS). Independent federal actuaries estimate that the amount climbed to $3.65 trillion in 2018, and the Organization for Economic Co-Operation and Development (OECD) ranks the United States as the country with the highest health expenditure per capita. According to CMS projections, US spending will continue to grow at an average rate of 5.5% annually through 2026, when it is expected to reach $5.7 trillion and account for 19.7% of GDP. These massive and steadily rising costs are a source of concern for the government, which is constantly exploring means of reining in healthcare expenses, including through preventive measures and investment in research projects. Among the most promising new developments is pharmacogenomic testing, which involves studying the impact of people’s genetic makeup on their response to drugs so that effective and efficient treatment regimens can be devised

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Mr. Frank Magliochetti MBA
Managing Partner
Parcae Capital

www.parcaecapitalcorp.com
www.frankmagliochetti.com

Bedside vs Telemedicine Assessments

Telemedicine for Assessing Levels of Consciousness in Comatose Patients: How Does it Compare to Bedside Assessment?

Effective care for comatose patients in intensive care units (ICUs) depends on proper intervention based on reliable assessment. Researchers recently conducted a study at Mayo Clinic Hospital in Arizona to compare the effectiveness of using telemedicine to assess levels of consciousness in comatose patients with standard bedside assessment.

Proper intervention relies on the ability to recognize changes in a comatose patient’s clinical status quickly. This had usually meant that, in order to complete an assessment, the practitioner needed to be in the same room. Advanced medical technology is changing all that and robotic medicine now allows clinicians to assess patients from across the hospital or from across the world.frankmagliochetti_Telemedice_HealthcareTrends-Innovations

Telemedicine has been around since the 1960s, when NASA built telemedicine technology into astronauts’ suits. Prior to this technology, astronauts had to rely on crewmates for an accurate diagnosis. Monitors in the suits sent biometric information about the wearer back to earth for assessment.

Computers have revolutionized telemedicine and the internet helps doctors assess patients living in remote places. This is especially helpful for patients living in underserved areas.

Despite major advances, many still worry about the effectiveness in using this technology for the most critically ill patients. A new study published in Telemedicine and e-Health should help to dispel this fear, with researchers showing that robotic telemedicine can be used successfully to complete assessments in comatose ICU patients.

Testing the Reliability of Telemedicine in the Assessment of Levels of Consciousness

Researchers enrolled 100 patients from Mayo Clinic Hospital in Arizona into the study, which occurred over a 15-month timeframe. Mean age of patient participants was 70.8 years. On average, each examination took just over 5 minutes.

Sixteen medical doctors also participated by using two scoring systems, the Glasgow Coma Scale (GCS) and the Full Outline of UnResponsiveness (FOUR) score, to assess patients’ levels of consciousness. The researchers randomly assigned two practitioners to each patient; one doctor used real-time audio and a visual robotic telemedicine system to perform the assessment and the other clinician conducted an assessment at the patient’s bedside. Each used GCS and FOUR scales.

The researchers used paired t-test and Pearson correlation coefficient (PCC) to compare the GCS and FOUR scores between bedside and Telemedicine_FrankMAgliochetti-HealthcareReportremote physician.

Differences in GCS and FOUR scores between remote and beside assessment were small. The mean Glasgow Coma Scale score at bedside was 7.5 while the mean GCS score for the remote examination was 7.23. Scores were comparable in the FOUR total scores too, with a mean bedside score of 9.63 and a mean remote score of 9.21.

The researchers also asked the clinicians about their overall satisfaction and ease of use. Ninety-five percent of remote providers rated GCS and 89% rated FOUR score as good (4/5).

Conclusions

The study is the first to evaluate the effectiveness of telemedicine in assessing patients with depressed levels of consciousness. The results suggest that doctors can reliably assess levels of consciousness in comatose patients using existing robotic telemedicine technology. Healthcare providers could adopt telemedicine to help evaluate critically ill patients in neurologically underserved areas.

“This is good news in many ways,” states lead author of the study, Amelia Adcock, M.D, in a press release issued by Mayo Clinic. “We use telemedicine frequently when evaluating acute stroke patients. This study suggests yet another way telemedicine can enhance patient care. There is a shortage of intensive care unit providers and facilities with round-the-clock patient coverage. Telemedicine can provide a way to ameliorate this shortage and improve early evaluation of critically ill patients.”

Source

http://online.liebertpub.com/doi/10.1089/tmj.2016.0225

Frank Magliochetti is Managing Partner for Parcae Capital

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release new sites dedicated to the industry. Frank currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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