Foundation Medicine Expands Companion Diagnostics Offerings

FoundationOne CDx has earned yet another approval from FDA, making the companion diagnostic now available for 19 FDA-approved targeted therapies. It can now be used as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. FDA approved Piqray in May 2019, and it is the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer, Novartis reported. Prasanth Reddy, MD, MPH, CPE, FACP, VP of Medical Affairs at Foundation Medicine Inc., told MD+DI recently that the company’s “tests are for advanced cancer patients and provide information about clinically relevant biomarkers and genomic alterations to help match patients to approved targeted therapies, immunotherapies, and clinical trials—giving doctors and patients powerful actionable insights for navigating cancer care.” Reddy explained that both the tissue-based test FoundationOne CDx and the blood-based test FoundationOne Liquid can detect guideline recommended genes and biomarkers for patients with breast cancer with ERBB2 (HER2), BRCA1, and BRCA2, and additional alterations in genes known to be relevant in breast cancer, such...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news