Quest Diagnostics Inc. has joined the competitive field of BRCA diagnostic testing for the risk of inherited breast or ovarian cancer with the BRCAvantage genetic test, launched Oct. 15.

Quest’s said it planned to launch a BRCA diagnostic test soon after the Supreme Court ruled in June that Myriad Genetics Inc. patents on the BRCA1 and BRCA2 genes are invalid (See Also see "Diagnostic Companies Rush To Test Formerly Off-Limit Genes" - Medtech Insight, 24 June, 2013..)

Quest is Myriad’s largest competitor. In the release announcing the BRCAdvantage launch, Quest points out that is serves about half of all doctors in the U.S. and promising to provide clinicians and patients with access to third-party genetic counselors.

The company’s website indicates that will offer four versions of the BRCA test. The most comprehensive version will cost $2,500, more than 25 percent less than Myriad’s counterpart, BRACAnalysis, which costs $3,400.

In an Oct.15 research note, RBC Capital Markets analyst Michael Yee wrote, “The relatively close price parity to Myriad’s test renders the 'worst case' scenario of super-low price and rapid erosion for Myriad a bit less likely. We note that Quest's launch as a service rich-oncology suite also partly validates Myriad‘s business model of value-based, rather than cost-based, pricing.”

Quest has the size and reach to expand the market for BRCA testing, Yee wrote. Quest reported 2012 revenues of $7.4 billion.

Quest simultaneously released the results of a survey that found that 72 percent of U.S. women were not aware of BRCA testing and only 29 percent said they know what a genetic counselor is.

Myriad Is Ready To Compete

“Our biggest advantage is that Myriad’s quality provides healthcare providers with the confidence they need when providing hereditary cancer testing for patients,” said Myriad spokesman Ronald Rogers in a statement. Myriad says that its test’s percentage of genetic variants of unknown significance (VUS) is less than 3 percent, while the BRCAvantage product guide says variants of unknown significance occur in about 13 percent of people tested with BRCAvantage, meaning that 13 percent of patients will receive indeterminate result from the test when trying to find out if they are at increased risk for breast or ovarian cancer.

“This is the low bar they are setting for expectations since they are just beginning to test large numbers of patients,” RBC Capital Markets associate Charmaine Chan wrote in an email to “The Gray Sheet.” Meanwhile Quest spokeswoman Wendy H. Bost said in a statement that Quest expects the VUS for BRCAvantage to be in the low single digits.

To lower a test’s VUS, uncertain variants must be reclassified as deleterious or benign. This can be achieved by checking the history of other people with the variant and requires lots of clinical data. Myriad has been developing its proprietary genetic database to help maintain the BRACAnalysis test’s predominant position. (See Also see "Myriad Wields Proprietary Database To Protect Testing Market" - Medtech Insight, 30 August, 2013..)

Competitors such as Ambry Genetics say they have achieved a low single digit VUS by collaborating with other labs and using public databases.

Suits, Countersuits, Preemptive Suits And Predictive Suits

In anticipation of a legal challenge, Quest filed a preemptive declaratory judgment against Myriad in U.S. District Court shortly before its Oct. 15 announcement, arguing that is it not infringing on any of Myriad’s remaining patents protecting the BRACAnalysis test.

Myriad’s Rogers told “The Gray Sheet” that his company received a copy of the court filing on Oct. 16 and the company’s lawyers are reviewing it.

The litigation involving a lawsuit against Ambry Genetics and Gene By Gene Ltd. for allegedly violating Myriad’s patents protecting the BRACAnalysis test is in the preliminary stages, Rogers said. The two companies responded with a countersuit against Myriad. (See Also see "News Briefs: Device Tax Repeal Update; Surgery Firms Merge; Medtronic’s Drug-Eluting Balloon" - Medtech Insight, 19 August, 2013..)

The final hearing on Myriad’s request for a preliminary injunction against the two companies’ tests was held Oct. 7.

“The bar is very high for a [preliminary injunction],” Rogers said. “Even if we weren’t granted the PI that wouldn’t necessary signal how the case would go one way or the other. We could still go on and win the trial.” RBC equity analysts said the chances of Myriad receiving a preliminary injunction are slim.

“Counsyl is the next competitor to watch,” RBC’s Yee predicts, because it also filed a preemptive declaratory judgment similar to Myriad’s, making the genetic testing company the likely next entrant into the marketplace.

Quest Enters Market For BRCA Gene Testing

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