CUPERTINO, CA & DELRAY BEACH, Fla.--(BUSINESS WIRE)--OneCellDx and Genetics Institute of America announced today that they have signed a memorandum of understanding for a diagnostics commercialization agreement for the OneCellDx OncoPredikt HRD Assay. 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.
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 Annual Meeting (ASCO), June 3-7, 2022, Chicago. Genetics Institute of America and OneCellDx will launch the LDT through HRD Pharma Development programs.
About OneCellDx
One Cell Diagnostics, Inc. is a genomics-based Precision Oncology Diagnostics company in Cupertino, CA. We have developed proprietary AI algorithms and leveraging AI and bioinformatics for developing first-in-class, clinically and analytically validated lab tests decoding actionable genetic alterations in individual tumors to help clinicians develop personalized treatment plans for patients. OneCellDx has developed two tests: OncoPredikt HRD - AI-enabled HRD prediction from H/E image, and OncoIndx - NGS-based comprehensive gene panel assays for multiple cancer types to identify key actionable biomarkers. For more information, please visit https://www.onecelldx.com/.
About Genetics Institute of America
Genetics Institute of America is a national high complexity molecular laboratory dedicated to heightening the awareness of early intervention and genetic testing to promote longevity and quality of life outcomes by focusing on DNA, RNA, and Proteins. Our modern CAP Accredited CLIA-certified laboratory facility in Delray Beach, FL, contains the most current technology, allowing us to provide leadership in both research and clinical laboratory testing. For more information, please visit http://www.GenLabUS.com/.
