With LabCorp ($LH) unleashing a series of predictive cancer diagnostic tests focused on BRCA mutations, a market once dominated by one major player is now crowded with least 7 rivals. Such is the aftermath of a U.S. Supreme Court decision over the summer that helped open the door to competition involving BRCA-related diagnostic tests.
LabCorp, based in Burlington, NC, disclosed this week that it had unveiled a "suite" of assays under the BRCAssure BRCA1/2 Analysis name to test patients for BRCA1 and BRCA2 gene mutations that may place them at much higher risk of hereditary breast and ovarian cancer. These mutations also increase the likelihood of pancreatic, prostate, melanoma, stomach, esophageal and bile duct cancers, the company noted.
BRCAssure even has a special panel for Ashkenazi Jews, screening for three known pathogenic variants (two in BRCA1 and one in BRCA2) that have a 2% combined frequency in the Jewish population, the company said.
Myriad Genetics ($MYGN) is the dominant player in the BRCA-related cancer diagnostic test space. But the Utah company faced new challenges when the U.S. Supreme Court ruled against patenting genes that occur in nature but upheld the right to patent genes tweaked in the lab--a process that invalidated some Myriad patents but upheld others.
Since then, Invitae, Quest Diagnostics ($DGX), BioReference Laboratories ($BRLI), Gene By Gene and Ambry Genetics have launched BRCA-related tests of their own. Myriad has sued all of them for allegedly violating Myriad's testing process, and most have countersued or filed preemptive lawsuits in a bid to establish patent legitimacy.
There's no word yet whether Myriad will be suing LabCorp, too. A company spokesman hadn't yet responded to a FierceDiagnostics email request for comment at presstime.
As for LabCorp, Chief Medical Officer Mark Brecher doesn't address the potential legal issues in the company's test announcement. Rather, he sticks to the marketing script.
"The National Comprehensive Cancer Network and the American College of Obstetricians and Gynecologists recognize the importance of screening for BRCA1 and BRCA2 mutations, and LabCorp's BRCAssure panels will make this testing more available," Brecher said in a statement.
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