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Tesis Biosciences to Develop miRNA Biomarkers for mTBI Diagnosis

NEW YORK — Tesis Biosciences wants to pinpoint biomarkers to better diagnose mild traumatic brain injury, the genetic sequencing company said Friday.

Phoenix-based Tesis Biosciences is proposing a study to develop molecular biomarkers to aid in differentiating mild traumatic brain injury (mTBI) from post-traumatic stress disorder (PTSD). For the study, the company will apply high-throughput genomic sequencing to analyze peripheral blood mononuclear cells from people who are and aren't affected by mTBI to identify changes in microRNA (miRNA) levels. Such changes may be able to serve as biomarkers for mTBI that can be turned into a testing panel, the firm said.

Tesis plans to apply for regulatory approval from the US Food and Drug Administration for the biomarker panel, which the company envisions will be "highly accurate, relatively inexpensive, portable, and minimally invasive," said company CEO Ron King in a statement.

Since changes in miRNA levels are related to the pathology of mTBI, these biomarkers could also be used to monitor progress of the condition after treatment.

Lack of diagnostic biomarkers delays treatment for patients with mTBI, also known as concussion, according to Tesis, and diagnosis is complicated by overlapping symptoms between mTBI and PTSD. mTBI, which affects about 20 percent of deployed US soldiers, can lead to persistent neurobehavioral impairment, chronic pain, and other issues.

The study will include veterans and civilians.

Genome Explorations, a genomic profiling and molecular diagnostic services company that Tesis acquired earlier this year and now serves as its clinical research and development arm, has been working to develop mTBI biomarkers for several years. Tesis Biosciences, founded in 2019 as Tesis Labs, renamed itself last year to reflect its increasing focus on clinical research and diagnostics.

Tesis Biosciences sells next-generation sequencing testing to customers including hospitals, medical practices, and accountable care organizations. The company also works with medical device and pharmaceutical companies to conduct studies that more quickly bring new products to market.