Myriad Genetics' Cancer Companion Diagnostic Test Gets FDA Nod
Zacks Investment Research | Dec 30, 2019 11:12PM ET
Myriad Genetics, Inc. (NASDAQ:MYGN) received the FDA clearance for its BRACAnalysis CDx, which is to be used as a companion diagnostic test by care providers to identify patients with metastatic pancreatic cancer. Notably, the identified patients will only be able to avail the test if they have a germline BRCA mutation and are eligible to be treated with PARP inhibitor Lynparza (olaparib).
Notably, the BRACAnalysis CDx (an in vitro diagnostic device) is the first and only FDA-approved genetic test to identify metastatic pancreatic cancer in patients. For investor’s note, Lynparza is jointly marketed by AstraZeneca (NYSE:AZN) and Merck (also known as MSD outside of the United States and Canada).
Myriad Genetics has been partnering with AstraZeneca since 2007 to receive various regulatory clearances for BRACAnalysis CDx, thus enabling more patients to benefit from treatment with olaparib.
With the approval, Myriad Genetics aims to globally strengthen its Hereditary Cancer testing business, an arm of the broader Molecular Diagnostic Testing segment.
Significance of the Clearance
Per the company, the regulatory clearance of the PARP inhibitor Lynparza and the subsequent expansion of the use of BRACAnalysis CDx as a companion diagnostic test is a step toward enhancing cancer care.
Pancreatic cancer is currently the third most common cause of cancer-related deaths in the United States. In view of such a scenario, the approval along with the updated National Comprehensive Cancer Network (NCCN) is significant because these will provide better treatment options to clinicians, who order testing at the time of diagnosis. Myriad Genetics believes that early diagnosis of patients with germline BRCA mutations will benefit the patients through precision therapies.
Industry Prospects
Per a report by Zacks Investment Research
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