Company in preparation for applying for formal FDA approval
PHOENIX, December 9, 2022 /PRNewswire/ — Tesis Biosciences, the leader in targeted genetic sequencing, has announced a study project designed to develop molecular biomarkers to accurately differentiate mild traumatic brain injury (mTBI) from post-traumatic stress disorder (PTSD). ). Enabling accurate diagnosis can improve treatments for people who are susceptible to mTBI and PTSD, such as US military personnel and athletes as well as civilians of all ages.
The new study will use a high-throughput genomics approach to analyze peripheral blood mononuclear cells (PBMCs) from veterans and civilians affected and unaffected by TBI. The study will seek to identify complex changes in micro-RNA (miRNA) levels that may function as a panel of sensitive and specific biomarkers for mTBI. Each group in this cohort will also be matched for PTSD.
Tesis is preparing to seek formal FDA approval for this panel, which will outline research and development efforts to date as well as the scientific and technical merit and feasibility of a new concept or innovation that has the potential to develop into new products, processes, or services.
mTBI affects approximately 20% of US military personnel deployed, which translates to more than 500,000 service members and veterans. Of these affected soldiers, 15-30% suffer from persistent neurobehavioral disorders for months or years, including cognitive dysfunctions, sleep disturbances, emotional distress, depression and chronic pain.
The current lack of readily available and accurate diagnostic biomarkers for mTBI often impedes the timely application of appropriate treatment and the reintegration of affected veterans into normal civilian life. Additionally, a significant overlap of symptoms of mTBI with those of PTSD further complicates the accurate diagnosis of mTBI.
“The lack of precise tools to protect our soldiers and all those who may suffer from TBI is unacceptable,” said Ron King, CEO of Tesis. “By developing an mTBI molecular biomarker that is highly accurate, relatively inexpensive, portable, and minimally invasive, we can improve outcome predictions and enable individualized treatments for our veterans and other Americans with mTBI.”
Genome Explorations, the research and clinical development division of Tesis, has been working on this project for several years, which has resulted in two peer-reviewed publications demonstrating the usefulness of molecular biomarkers for these disorders. The Tesis approach takes advantage of global miRNA profiles as diagnostic indicators of complex pathological changes and immune responses that reflect neuropathological conditions. Information from such a test will improve the prediction of mTCL results if it is available to clinicians when determining acute management and rehabilitation treatments for patients. As these biomarkers are involved in the pathology of disorders, they will also monitor the progress of short-term and long-term therapies.
About Tesis Biosciences
Tesis Biosciences’ genetically integrated medical platform has revolutionized targeted genetic sequencing. Our mission is to change medicine by providing doctors, hospitals and researchers with the tools to help patients treat and overcome major chronic diseases such as heart and lung disease and cancer through advanced genetic testing. Tesis offers healthcare providers and physicians access to our unique genetic testing and precision medicine, enabling them to create personalized care plans for the treatment of chronic conditions – individually and across generations. We also enable medical device and pharmaceutical companies to bring new products to market and create a robust repository of genetic data and research. Learn more at www.tesisbiosciences.com.
Amendola Communications on behalf of Tesis Biosciences
SOURCE Tesis Biosciences
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