Myriad vs. Quest over BRCA testing: It's getting serious

Myriad Genetics ($MYGN) is fighting back hard against rival Quest Diagnostics' ($DGX) decision to launch a new, cheaper BRCA test that challenges its own offerings, and a spokesperson didn't overtly rule out a lawsuit going forward.

That's something Quest clearly anticipated. Before it launched its BRCAvantage test this week, the company filed a U.S. District Court lawsuit seeking a ruling that it doesn't violate any patent Myriad owns regarding BRCA1 and BRCA2 mutations in measuring the risk for hereditary breast and ovarian cancers. Myriad spokesman Ronald Rogers told FierceMedicalDevices via email that "once we are served with the complaint, we will read it and consider our options."

Rogers also issued a four-point rebuttal against Quest's new offering compared to Myriad's BRACAnalysis test, which has dominated the market and now faces challenges in the wake of a U.S. Supreme Court ruling earlier this year that invalidated some of Myriad's patent claims, but backed others. His statement, in part, knocks the accuracy of the Quest BRCA test, and questions whether the technology behind it has FDA approval for anything beyond "research purposes." (Naturally, Quest disagrees.)

Here's Rogers' full statement as submitted to FierceMedicalDevices:

"1. Patients and providers should carefully evaluate the different testing options for BRCA as there are significant quality differences. For example, Quest is claiming a 99% accuracy rate, which means there is a potential for 170 errors for every BRCA 1 and 2 test. In comparison, Myriad's analytical sensitivity is >99.98%.

2. Quest is using a large rearrangement technology (MLPA) that is not approved by the FDA for clinical use in the United States and according to the manufacturer, MRC Holland, is only to be used for 'research purposes'. In fact, the MRC Holland website states: 'All SALSA MLPA kits are sold by MRC-Holland for research purposes only. Our kits are not FDA/CE certified for diagnostic purposes!'

3. Quest is referencing a 13% uncertain variant rate compared to Myriad's 2%, which means 11% of Quest patients will receive an uncertain test result that would have been interpreted by Myriad.

4. With more than 1 million patients tested, Myriad is committed to providing the most accurate, timely information to assist patients and providers using BRCA test results to make life-saving decisions."

And here's Quest's full response, as submitted to FierceMedicalDevices by company spokesperson Wendy Bost:

"Our BRCAvantage test service, including our MLPA technology, was developed and validated in a manner wholly compliant with federal law and regulations, the Clinical Laboratory Improvement Amendments, and our own high standards for quality.

Based on our validation study, our BRCAvantage service is highly reliable and we are confident it will deliver excellent performance. We expect a rate of variants of unknown significance to be in the low-single digits. We plan to submit those data and results from our validation study to a peer-reviewed journal and as a presentation at a scientific conference, and look forward to sharing this information, assuming acceptance.

Quest Diagnostics serves about 30% of American adults each year, giving us an ability to reach at-risk patients who could benefit from BRCA testing on a uniquely large scale. This means patients will have broader access to a quality BRCA testing option.

In sum, we are confident in our BRCAvantage service, which is based on the most advanced technologies and our deep expertise in cancer, women's health and genetics."

Myriad isn't just sparring with Quest. The company sued Houston's Gene By Gene in a patent-infringement case alleging that the company violated 9 patent claims involving the testing process when it began to offer BRCA1 and BRCA2 tests. Myriad and its fellow patent holders are also suing Ambry Genetics over the same issue. In both cases, Myriad wants its rivals to stop selling the tests and is demanding damages and royalties. But Quest is Myriad's biggest rival in the fight for supremacy in the BRCA testing field, and has both the size and the resources to fight back hard, so this definitely isn't over yet.