On May 31, 2022 OneCellDx and Genetics Institute of America reported that they have signed a memorandum of understanding for a diagnostics commercialization agreement for the OneCellDx OncoPredikt HRD Assay (Press release, Genetics Institute of America, MAY 31, 2022, View Source [SID1234615295]). Genetics Institute of America will create a laboratory developed test (LDT) based on OneCellDx’s proprietary AI Enabled Algorithm and assay . The OncoPredikt assay identifies Homologous Recombination Deficiency (HRD) in cancer patients with quicker turnaround times and lower costs.
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Current HRD prediction tests are expensive, time-consuming, require multi-technique processes, and often have sample QC rejection due to low DNA quantity. OneCellDx has developed a proprietary AI-enabled tool to predict key genomic signatures. Genetics Institute of America will run a validation study in its CAP Accredited, CLIA certified facility and launch the laboratory developed test upon successful completion and acceptance of the study.
"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 OncoPredikt HRD to market," said Mohan Uttarwar, Co-founder and CEO of OneCellDx.
"The ability to positively impact patients’ lives is one of the missions of Genetics Institute of America. Bringing the OncoPredikt HRD test to market will help in accelerating the development of novel pharmaceuticals, improving the care of thousands of patients," said Holly Magliochetti, CEO and Founder of Genetics Institute of America.
OneCellDx will present a poster session on OncoPredikt HRD at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), June 3-7, 2022, Chicago. Genetics Institute of America and OneCellDx will launch the LDT through HRD Pharma Development programs.