On July 21, 2020 Genetics Institute of America reported that it has received IRB approval to expand its Prostate Cancer Study (GH215) to include: Breast, Ovarian and Lung Cancers (Press release, Genetics Institute of America, JUL 21, 2020, View Source [SID1234562192]).
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Entopsis had earlier entered into a diagnostics commercialization agreement with Genetics Institute of America of Delray Beach, Florida focusing on Prostate Cancer. Genetics Institute of America will develop additional laboratory developed tests (LDT) based on Entopsis’ OpsisDxTM diagnostics platform. The purpose of these tests in Breast, Ovarian and Lung Cancers will be to enhance early detection and diagnosis while reducing unnecessary invasive procedures for patients who are suspected of having cancer.
Genetics Institute of America will run prospective, Institutional Review Board approved, validation studies in its CLIA licensed facility for each cancer type, and launch each laboratory developed test upon successful completion and acceptance of the study.
Entopsis consists of a team of scientists and engineers looking to re-focus the diagnostics industry on early detection and disease prevention with an eye towards improved ‘healthspans’. In 2016, Entopsis was awarded the "Most Disruptive Technology Award" by the Greater Miami Chamber of Commerce.
"We’re pure research scientists, so we’re excited to be working with the team at Genetics Institute of America on this venture," 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 additional OpsisDxTM tests to market will help in the care of thousands of patients," said Holly Magliochetti, CEO and Founder of Genetics Institute of America.
Genetics Institute of America will recruit leading physicians as co-investigators and additional study sites commencing immediately.