After Another Legal Setback on BRCA Testing, Myriad Considers Other Options

Myriad Genetics is continuing to legally duke it out with some of its competitors in breast and ovarian cancer genetic testing, but it is appearing increasingly likely that it will have to accept that the space will be crowded for the foreseeable future. A federal appeals court in Utah ruled in December that three patents held by Myriad for BRCA testing (it markets its own test as BRACA) should never have been issued in the first place, as they covered products that weren't eligible for legal protection. The appellate ruling follows on a 2013 U.S. Supreme Court ruling that barred companies from holding patents on single genes. That effectively opened up the market for BRCA testing, meaning Myriad's $4,000 list price for the test could be undercut by other labs. However, Myriad sued two of its would-be competitors, Ambry Genetics Corp. and Pathway Genomics, claiming their sequencing processes infringed on its existing patents. The decision issued last month involved the Ambry lawsuit. It not only upheld a trial court's decision to permit Ambry to continue marketing its own BRCA test, but went beyond the question originally posed and invalidated the patents Myriad had held. Myriad said it was disappointed in the decision and was considering its options. The company announced last month that it received FDA approval to use its BRACA assay as a companion diagnostic in conjunction with determining the use of the chemotherapy drug Lynparza for treating ovarian cancer patients. "The potential for Myriad to become a companion diagnostic could be meaningful," wrote William Blair & Co. Analyst Amanda Murphy in a recent report. Murphy noted that Myriad tests about a quarter of the nation's ovarian cancer patients, and that using the test as a companion diagnostic could double that market for the lab in the coming years. Takeaway: After another legal setback regarding its BRACA test, Myriad may have other avenues to grow that line of business.