by Jennifer Leib, Senior Vice President
The 2013 Supreme Court decision in Association for Molecular Pathology vs. Myriad Genetics overturned patents on naturally occurring DNA. Shortly after the decision, Ambry Genetics, GeneDx, Invitae and other laboratories announced plans to provide testing on the BRCA1 and BRCA2 genes, ending almost two decades of Myriad’s monopoly on these tests.[ i ] Advocates for the plaintiffs cited harms stemming from the patents including that they restrict patients’ access to lifesaving tests, fail to provide the ability for patients to obtain a second opinion, and they remove market incentives for the company to improve its test over time.
After the Supreme Court’s decision, Myriad continued to enforce its patents, engaging in expensive litigation with the handful of laboratories offering BRCA testing. However, earlier this week, Myriad announced that it is settling all lawsuits and no longer going to obstruct others from offering the test. Advocates for the plaintiffs rejoiced at the news, celebrating that after over seven years of advocacy, the breast cancer genes are truly and completely free.
Last fall, FDA published a draft guidance that would implement a framework to regulate all laboratory developed tests (LDTs) currently on the market to ensure that diagnostics are safe and effective.[ii] The proposed regulation requires LDT developers to submit applications for premarket approval (PMA) or 510(k) clearance for high and moderate risk tests respectively. PMA submissions often rely on clinical trial data as opposed to supporting effectiveness through the published literature. The draft guidance says that once finalized, if a PMA for a test currently exists, then laboratories with LDTs for that same intended use must file an application for PMA within 12 months (i.e. begin the process to come into compliance) or they must stop offering the test.
On December 19, Myriad received PMA for its BRCA test, called BRACAnalysis CDx.[iii] If the draft guidance were finalized in its current form, Myriad may once again have a monopoly on testing for the BRCA genes. PMAs are incredibly expensive and resource intensive. Even if a laboratory could find the funds to submit an application, the issue is that due to its patents, Myriad has locked up almost two decades worth of data on the BRCA genes. In fact, advocates for the plaintiffs have launched a Free the Data campaign in hopes to give researchers, clinicians, and the public access to Myriad’s data.[iv] Without it, laboratories may have to conduct their own clinical trials to collect the data required for a PMA application. Not only could this be cost prohibitive for laboratories and take years to complete, but it would be a waste of resources in that the association between mutations in the BRCA genes and hereditary breast and ovarian cancer is already well established.
When I spoke with investors at this year’s JP Morgan Healthcare Conference, they suggested Myriad’s strategy to seek a PMA was forward thinking and that FDA is essentially laying the groundwork to force Myriad’s competitors to stop selling their tests. So, is it a coincidence that just after a month of receiving FDA approval, Myriad suddenly wants to settle all of the outstanding lawsuits? FDA says the agency is changing its policy on enforcement discretion to promote patient safety and ensure that the LDTs in use are safe and effective. While good intentioned, the current draft guidance may have a very serious unintended consequence of creating test monopolies, which is never a good thing for patients.