Quest Diagnostics, 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.