Business
NeoGenomics and German Breast Group Announce New Data Demonstrating Clinical Potential of the RaDaR MRD Assay in HR+/HER2- Breast Cancer
FT. MYERS, FL / ACCESSWIRE / June 5, 2023 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology testing and global contract research services,
About this update from Neogenomics, Inc.
[{"type":"text","content":"FT. MYERS, FL / ACCESSWIRE / June 5, 2023 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology testing and global contract research services, today announced new data in support of its RaDaR® assay for the detection of molecular residual disease (MRD) and recurrence in patients with high-risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.Data from a retrospective analysis of the Phase 3 PENELOPE-B study was presented in part at the 2023 ASCO® Annual Meeting on Friday, June 2nd in Chicago, IL.In collaboration with the trial sponsor, German Breast Group (GBG), the study used NeoGenomics' RaDaR personalized MRD assay to assess the potential of circulating tumor DNA (ctDNA) analysis to predict future clinical relapse of patients enrolled in the PENELOPE-B trial.\"We are delighted that the development of liquid biopsies for the early detection of circulating tumor DNA is moving forward. There is an unmet need for early response evaluation in plenty of clinical situations, and these results support the potential benefits of the clinical utility of individualized assays, such as the RaDaR assay.\" said Professor Sibylle Loibl, MD, Chief Executive Officer of German Breast Group. \"Prognostic and predictive implications of circulating tumor DNA assays still need to be validated on a broader basis. Nevertheless, we are confident that prospective investigations on ctDNA will lead to their clinical application and ultimately improve patient outcomes.\"Patients in the trial had already completed neoadjuvant therapy and surgery, with or without radiation. The RaDaR assay analyzed ctDNA in blood samples from 78 patients collected at three points: prior to initiation of standard of care endocrine therapy with either palbociclib or placebo, during therapy, and at the end of treatment. ctDNA positivity was compared to patient outcomes.Nine percent of the patients had ctDNA detected at baseline (prior to the start of endocrine plus palbociclib or placebo). Of patients undetected at baseline, 4% had ctDNA detected in later samples and of patients detected at baseline, 29% became undetected in later samples, indicating that ctDNA positive patients may benefit from palbociclib. Detection of ctDNA following neoadjuvant chemotherapy, and surgery, is associated with a very high risk ...