On April 21, 2020 Entopsis, LLC reported that it has entered into a diagnostics commercialization agreement with Genetics Institute of America of Delray Beach, Florida (Press release, Entopsis, APR 21, 2020, View Source [SID1234556485]). Genetics Institute of America will create a laboratory developed test (LDT) based on Entopsis’ core diagnostic platform, OpsisDxTM . The purpose of the test will be to reduce or eliminate unnecessary prostate biopsies in men who are suspected of having prostate cancer.

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Current data show that only 34% of prostate biopsies result in a diagnosis of prostate cancer, resulting in thousands of unnecessary procedures each year, with resulting side effects and at great cost to the healthcare system. Early research data showed significant ability to stratify patients into the category of those who do not require prostate biopsy. Genetics Institute of America will run a prospective, Institutional Review Board approved validation study in its CLIA licensed facility and launch the laboratory developed test upon successful completion and acceptance of the study.

Entopsis is backed by Peter Thiel’s Breakout Labs and pursues the simple idea that an unbiased approach to diagnostics using signatures can be clinically and scientifically useful. In 2016, Entopsis was awarded the "Most Disruptive Technology Award" by the Greater Miami Chamber of Commerce.

"Our team of scientists and engineers have developed a uniquely impactful solution and are very excited to partner with the team at Genetics Institute of America in bringing OpsisDxTM to market," said Obdulio Piloto, PhD, Co-founder and CEO of Entopsis. "The ability to positively impact patients’ lives is one of the missions of Genetics Institute of America. Bringing the OpsisDxTM test to market has the potential to help improve urological care for thousands of men," said Holly Magliochetti, CEO and Founder of Genetics Institute of America.

Genetics Institute of America will recruit leading urologists as study sites having receiving IRB approval of the validation study protocol.