Quest Diagnostics ($DGX) is rolling out a new genetic screening diagnostic test designed to predict a patient's chances of getting breast and ovarian cancer. It's a direct challenge to rival Myriad Genetics ($MYGN) made possible by the U.S. Supreme Court ruling earlier this year that invalidated some of Myriad's patent claims. Expect Myriad to fight back.
For now, Quest is taking no chances. As The Wall Street Journal, Genome Web and Patent Docs reported, Quest's new two-part test dubbed BRCAvantage is designed to detect hereditary mutations in both BRCA1 and BRCA2, something that crosses very much into what had been an exclusive space for Myriad. Quest wants the U.S. District Court for the Central District of California to determine that it doesn't violate any of the patents Myriad owns involving BRCA1 and BRCA2 to measure the risk for hereditary breast and ovarian cancers.
Wendy Bost, director of Media Relations at Quest Diagnostics, explained to FierceMedicalDevices that the company pursued its legal strategy "to ensure our BRCAvantage offering is broadly available in the United States so that patients and clinicians will have access to this new and unique BRCA option."
A preemptive decision could avoid trouble. Earlier this year, the U.S. Supreme Court upheld some of Myriad's patent claims in the space and vacated others. Myriad has subsequently sued Gene By Gene and Ambry Genetics, after both companies launched tests involving BRCA1 and BRCA2 mutations.
Quest is playing hardball. According to The Wall Street Journal, the company's test will cost $2,500, versus a list price of $3,340 for Myriad. What's more, Quest told the newspaper it will help patients and physicians quicken the insurance reimbursement process for its new test at no cost.
Myriad spokesman Ronald Rogers said in a statement that his company had not yet received the Quest complaint and that it was too soon to comment on the matter right now. But, he said, Myriad and its fellow holders of patents relating to the company's signature BRCA1 and BRCA2 gene tests will do what they must to keep them protected.
"We continue to believe that patent claims related to BRCA1 and BRCA2 gene testing are valid and enforceable," Rogers said. "Myriad and the other owners of the BRCA patents at issue--including the University of Utah, the Hospital for Sick Children, Endorecherche, Inc., and the Trustees of the University of Pennsylvania--are prepared to defend our intellectual property rights."
Underscoring the importance of Myriad's BRCA tests to the company's bottom line, Rogers also noted that Myriad's BRACAnalysis test "has been used by more than 1 million patients ... is reimbursed by nearly all private and public insurance plans and is widely accessible for patients." Quest has taken the biggest move yet among Myriad's rivals to grab a piece of that business for itself.
- here's The Wall Street Journal story (subs. req.)
- here's the Genome Web story (sub. req.)
- check out the Patent Docs blog
- consider FierceDiagnostics' take
- Quest's announcement is here
Editor's note: This story has been expanded to include discussion about Quest's debut of its new BRCA test and other related information, as well as statements from Myriad Genetics and Quest.