The American Society of Clinical Oncology (ASCO) updated its guidelines to recommend use of Biotheranostics Inc.’ Breast Cancer Index (BCI) molecular gene-expression test to aid decisions on extended endocrine therapy in certain patients with the most common type of breast cancer.
Myriad Genetics Inc. is launching a new suite of genetic tests designed for personalizing chemotherapy treatment. The Precise oncology offering includes Myriad’s precise tumor molecular profile test and two companion diagnostic tests, Mychoice CDx and Bracanalysis CDx. The company said the combination of germline, somatic and companion testing aims to maximize information for oncologists as they assign individual treatment plans. Results from each test are gathered as a single report accessed on an online portal.
Laboratory Corporation of America Holdings (Labcorp) further consolidated its position as a leading provider of rheumatoid arthritis testing with a definitive agreement to acquire the Vectra assay from Myriad Genetics Inc. along with other assets of the Salt Lake City-based company’s autoimmune business unit in a deal valued at $150 million in cash. The transaction is expected to close by the end of the third quarter of 2021.
Castle Biosciences Inc. deepened the moat around its position in melanoma diagnostics with the acquisition of Myriad Mypath LLC from Myriad Genetics Inc. The acquisition gives Castle (NASDAQ:CSTL) the Myriad Mypath Laboratory in Salt Lake City where the Mypath Melanoma 23-gene expression profile (GEP) test is owned and offered. Mypath Melanoma joins Castle's Decisiondx Diffdx-Melanoma, enabling Castle to provide comprehensive molecular testing for difficult-to-diagnose melanocytic lesions.
Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
The U.S. Centers for Medicare and Medicaid Services (CMS) has significantly relaxed the national restrictions on coverage of next-generation sequencing for cancer, affirming that early-stage breast and ovarian cancer patients will be covered. However, Medicare administrative contractors can cover tests that have not been reviewed by the FDA, a move that should also significantly boost utilization for makers of next-generation sequencing systems in clinical labs.
