, one of the largest clinical laboratories in the U.S., started offering BRCA testing this week as it seeks to tap into the lucrative breast cancer genetic testing market. But Quest and other companies that plan to offer less-expensive testing still face legal battles with the company that previously was the sole provider of these tests.
Madison, N.J.-based Quest is the largest company to begin offering genetic tests that identify the BRCA1 and BRC2 genes—which are associated with higher risks for hereditary breast and ovarian cancers—since the Supreme Court in June ruled
that Myriad Genetics' patents for naturally occurring DNA were invalid. Until the ruling, Myriad Genetics was the sole provider of BRCA testing in the U.S.
The Supreme Court decision was expected to open the BRCA testing market to new entrants that likely would charge lower prices than the $3,340 price tag on Myriad's tests. Quest plans to charge $2,500 for genetic tests that identify BRCA 1 and BRCA2 gene mutations. It is also offering three other related tests that each cost $500.
“We believe that the tests need to be much more accessible and affordable,” said Dr. Jon Cohen, Quest's senior vice president and chief medical officer.
Up to 10% of female breast cancers are associated with inherited gene mutations. About 230,000 people each year are newly diagnosed with breast cancer and roughly 22,000 women are diagnosed with ovarian cancer annually. Myriad's end-of-year financial filings show that BRCA testing generated 75%, or $460 million, of Myriad's total revenue in 2013.
Patient groups and physicians have said they expect to see further price decreases as the BRCA testing market becomes more competitive, as well as improvements in the quality of the testing that is currently available.
But at least two of the smaller labs that have said they plan to provide BRCA testing—Ambry Genetics in Aliso Viejo, Calif., and Gene by Gene in Houston—have been sued by Myriad. One hour after the Supreme Court ruling, Ambry had announced plans
to sell BRCA testing panels for about $2,200. Gene by Gene's test is expected to cost around $1,000.
The week before the Oct. 15 commercial launch of its BRCA testing program, Quest filed a legal action in federal court in the Central District of California seeking a declaratory judgment that it is not in violation of Myriad's patent claims. “Myriad's aggressive conduct has deterred other competitors from entering the BRCA1/BRCA2 genetic testing market for fear of being sued,” Quest said in the legal action.
Along with the lawsuits it has filed, Myriad also is seeking to reassure investors and providers and encourage ongoing utilization of its tests. “Our biggest advantage is that Myriad's quality provides healthcare providers with the confidence they need when providing hereditary cancer testing for patients,” Ronald Rogers, a Myriad spokesman, said. “We encourage patients and providers to carefully evaluate the different testing options for BRCA as there are significant quality differences.”
The lawsuits filed by Myriad have chilled other potential market entrants. Pathway Genomics, which said in June it planned to offer BRCA testing, later said it would delay the launch as a result of the lawsuits, according to Quest's legal action.
A startup company called Genomic Liberty that also planned to offer BRCA testing at a reduced rate similarly is waiting to see how the lawsuits play out before entering the market, said Jeffrey Rosenfeld, a co-founder of Genomic Liberty.
Labs are likely taking a wait-and-see approach to the lawsuits because many aren't large enough to support and survive a lawsuit, said Karuna Jaggar, executive director for Breast Cancer Action, one of the plaintiffs in the Supreme Court case. She said Quest's move is “an important and interesting turn in BRCA testing.”
Breast Cancer Action supports increased competition and lower prices for the tests, Jaggar said. But both providers and patients need to pay close attention to the quality of the tests, the accessibility and affordability of testing, and whether companies are overselling the need for and benefits of testing to populations of women who are not at risk for BRCA gene mutations.
“We need to maintain some appropriate skepticism and rigor about any new test that comes on the market,” she said. Follow Jaimy Lee on Twitter: @MHjlee