Company in preparation for formal FDA approval submission
PHOENIX, Dec. 9, 2022 /PRNewswire/ -- Tesis Biosciences, the leader in targeted genetic sequencing, has announced a proposed study designed to develop molecular biomarkers to precisely differentiate mild traumatic brain injury (mTBI) from post-traumatic stress disorder (PTSD). Enabling a precise diagnosis can improve treatments for individuals who are susceptible for mTBI and PTSD such as U.S. military members 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 (PBMC) from mTBI-affected and non-TBI-affected veterans and civilians. The study will seek to identify complex changes in micro-RNA (miRNA) levels that may function as a sensitive and specific biomarker panel for mTBI. Each group in this cohort will also be matched for PTSD.
Tesis is preparing to apply for formal FDA approval of this panel, which will describe the 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 for development into new products, processes, or services.
mTBI affects approximately 20% of deployed U.S. service members, which translates into more than 500,000 service members and veterans. Of those impacted soldiers, 15% to 30% experience persistent neurobehavioral impairments for months or years, including cognitive dysfunction, sleep disruption, emotional distress, depression, and chronic pain.
The current lack of easily accessible and accurate diagnostic biomarkers for mTBI often impedes the timely application of appropriate therapy and the re-integration of affected veterans back into normal civilian life. In addition, a significant overlap of mTBI symptoms with those of PTSD further complicates accurate mTBI diagnosis.
"The lack of accurate tools to protect our soldiers and all individuals who potentially suffer from TBI is unacceptable," said Ron King, CEO of Tesis. "By developing a molecular biomarker mTBI 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, Tesis' clinical research and development division, has been working on this project for several years resulting in two peer-reviewed publications demonstrating the utility of molecular biomarkers for these disorders. The Tesis approach takes advantage of global miRNA profiles as diagnostic indicators of complex pathological changes and of immune responses that reflect neuropathological conditions. Information from such a test will improve mTBI outcome prediction if available to clinicians when they determine acute management and rehabilitation treatments for patients. As these biomarkers are involved with the pathology of the disorders, they will also monitor progress of therapies both short- and long-term.
About Tesis Biosciences
Tesis Biosciences' genetically integrated medical platform has revolutionized targeted genetic sequencing. Our mission is to change medicine by providing physicians, hospitals, and researchers with the tools to help patients treat and overcome major chronic conditions 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 treating chronic diseases – 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