"He cites BCR-ABL—testing that is important for some chronic myelogenous leukemia patients—as an object lesson in why responsible patent holders with FDA-approved tests are necessary. Imatinib (Gleevec) was approved for CML more than a decade ago, but there was no international harmonization of BCR-ABL testing. As a result, for many years testing was “all over the place.” As CAP proficiency tests have shown, “you cannot compare BCR-ABL testing from site to site.” It was only in 2016 that an FDA-cleared 510(k) product was launched, Dr. Stenzel says.
“If there had been a single responsible patent holder for BCR-ABL testing, it is quite likely this situation would have been rectified long ago—or better yet, addressed from the start.”
Similar concerns apply to PD-L1, which is required for some drugs but not others. “Multiple tests are on the market but do not agree with one another because there is no international harmonization. So laboratories have a huge dilemma as to which approved testing to perform.”
Dr. Klein and Dr. Stenzel agree the data are not all in, and several important legal questions await resolution in the wake of Myriad. Funding has dried up for many new startups, Dr. Stenzel says, because of the uncertainty. “If you file a patent now and it’s unsuccessful, it goes public. And everybody knows the genes you were looking at, without any protection. It’s a real challenge in the U.S. Until we know exactly what we can and cannot do with the patent office or until the pendulum swings back, it will be hard to raise the capital to take new molecular diagnostics all the way to the FDA”—which he says is critical for the field to advance."