Good for labs? Good for patients? Good for providers? It was the rarest kind of decision from the U.S. Supreme Court—a unanimous one. The 9-0 opinion announced on June 14 was penned by one of its most conservative jurists in favor of a case argued by the American Civil Liberties Union—at a time when consensus in Washington is rare as a humidity-free July. Yet the decision barring Myriad Genetics from patenting unaltered genetic material appears not to have a winner and a loser—just winners, according to most of the interested parties. The laboratory industry says the ruling will promote more laboratory-developed genetic tests and create more options for patients. “We believe the High Court today removed a significant barrier to innovation in molecular pathology testing,” said Roger D. Klein, M.D., professional relations committee chair for the Association for Molecular Pathology, which was the primary plaintiff in the case. “And we look forward to future advancements in clinical diagnostics and therapeutics that will accrue to the benefit of our patients and our field.” Indeed, at least three labs announced they would offer BRCA testing immediately, one of them at a discount approximately 75 percent of what Myriad charges to detect a […]
Good for labs? Good for patients? Good for providers? It was the rarest kind of decision from the U.S. Supreme Court—a unanimous one. The 9-0 opinion announced on June 14 was penned by one of its most conservative jurists in favor of a case argued by the American Civil Liberties Union—at a time when consensus in Washington is rare as a humidity-free July.
Yet the decision barring Myriad Genetics from patenting unaltered genetic material appears not to have a winner and a loser—just winners, according to most of the interested parties.
The laboratory industry says the ruling will promote more laboratory-developed genetic tests and create more options for patients.
“We believe the High Court today removed a significant barrier to innovation in molecular pathology testing,” said Roger D. Klein, M.D., professional relations committee chair for the Association for Molecular Pathology, which was the primary plaintiff in the case. “And we look forward to future advancements in clinical diagnostics and
therapeutics that will accrue to the benefit of our patients and our field.”
Indeed, at least three labs announced they would offer BRCA testing immediately, one of them at a discount approximately 75 percent of what Myriad charges to detect a genetic predisposition for breast cancer.
Nevertheless, Myriad is also pleased that the decision, penned by Associate Justice Clarence Thomas, will permit the Salt Lake City-based company to retain patents on complementary DNA (cDNA)—material that has been modified for laboratory tests.
“We believe the court appropriately upheld our claims on cDNA and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” said Peter D. Meldrum, Myriad’s chief executive officer.
And patients are also expected to benefit.
“The Supreme Court decision invalidating Myriad Genetics’ patents on BRCA1 and BRCA2 is a huge victory for patients,” said Debra Leonard, M.D., chair of the personalized health care committee for the College of American Pathologists. “It will allow women to receive life saving, state-of-the-art genetic tests without being forced to trust one provider or one laboratory performing a single test to secure a diagnosis or inform treatment.”
Yet the investment market was a little less sanguine about the outcome. Initially Myriad stock was up after the Supreme Court announcement, but then it quickly plunged, losing nearly 14 percent of its value in trading the day the opinion was announced.
The losses came not long after Bank of America downgraded Myriad from buy to neutral and also cut its outlook for its share price.
Analysts noted that Myriad will soon be competing with other labs that will offer similar tests, including Bio-Reference Labs, Quest Diagnostics, and Ambry Genetics, a company affiliated with the University of Washington.
An affiliate company of Gene by Gene, the Houston-based lab that has been
focused on low-cost genetic testing, announced within a couple of hours of the Supreme Court decision that it will offer a BRCA 1 and 2 test for $995—compared to the $3,000 to $4,000 Myriad charges. Bennett Greenspan, Gene by Gene’s CEO, noted in a statement that competition is crucial to keeping prices down.
“The noise around competition is a continued overhang on the [Myriad] stock and probably will not be resolved into at least the calendar fourth quarter,” said Amanda Murphy, an analyst with William Blair & Co.
But Murphy expressed some doubt that other labs will be able to quickly enter the BRCA market: “The IP landscape is far from clear. Myriad retains 23 patents and still has almost 500 claims around the BRCA1/2 testing franchise,” she said.
Murphy also noted that Myriad has a huge database of genetic mutations—16,000 versus the mere 1,000 in the public domain.
GeneDX, a Bio-Reference subsidiary, announced it would offer a 27-gene panel for breast and ovarian cancers. It did not disclose pricing.
Gene by Gene laboratory director Concetta Bormans noted that her company’s test would be composed of a straight sequencing assay. The test would be on a buccal swab taken at a doctor’s office and sent in for examination.
Bormans said the company expects a four-to-six week turnaround for testing. “But if we’re deluged with a lot of tests, it could take longer,” she said.
