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Myriad Awaits BRACAnalysis CDx Approval as it Works to Move Hereditary Cancer Testing to MyRisk

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NEW YORK (GenomeWeb) — Fiscal year 2015 will see a significant shift for Myriad Genetics in hereditary cancer testing, as it aims to move all of its comprehensive BRACAnanlysis customers to its newer sequencing-based myRisk Hereditary Cancer panel by mid-2015.

Meanwhile, the company is hoping the US Food and Drug Administration will soon approve the companion diagnostic version of BRACAnalysis alongside AstraZeneca's olaparib

In April, Myriad submitted the first module of its premarket approval application to the FDA for BRACAnalysis as a companion to olaparib. The FDA initially granted priority review status to olaparib with a PDUFA date of Oct. 3.

During a call discussing the company's fourth quarter and fiscal year 2014 earnings, Mark Capone, president of Myriad Genetics Laboratories, said that AstraZeneca and Myriad met with the FDA this summer to review the status of their application.

In July, he said, AstraZeneca submitted a major amendment, and the FDA provided the companies with a revised PDUFA data of Jan. 3, 2015.

On a broader basis, Capone said Myriad has seen BRACAnalysis CDx adopted at this point in a total of 13 clinical trials representing six unique patient populations, who potentially represent an exponential increase in the current market for BRACAnalysis in oncology.

Myriad also said it presented several studies in Q4 at the annual meeting of the American Society of Clinical Oncology, including data demonstrating both its BRACAnalysis CDx and myChoice homologous recombination deficiency tests were highly effective at predicting response to platinum-based chemotherapies.

During the call, Myriad CEO Peter Meldrum said the company recently signed its sixth commercial collaboration with myChoice HRD, and is on schedule to launch the test in the second half of its next fiscal year.

"Given strong clinical support," he said, Myriad believes the test "will become the gold standard companion diagnostic for platinum-based therapies, and that pharmaceutical partnerships could also expand the market for the test to predicting response to PARP inhibitors and other classes of drugs."

As the company looks to the future of the HRD test and of BRACAnalsysis as a companion diagnostic to olaparib and potentially other drugs, Myriad is also gearing up to shift the way it sells hereditary cancer testing, with the goal of no longer offering BRACAnalysis as a comprehensive test for hereditary breast cancer and instead testing all patients using its broad sequencing-based myRisk panel.

A little more than one year after the Supreme Court's decision with regard to its BRCA patent claims, which opened the market to competitors in hereditary breast cancer testing, Myriad Genetics continues to report revenue growth.

The Salt Lake City-based molecular diagnostics firm brought in total revenues of $188.8 million for the three months ended June 30, compared to revenues of $174.1 million for the fourth quarter of 2013, beating the consensus Wall Street estimate of $187.7 million.

For fiscal year 2014 Myriad's revenues increased 27 percent year over year to $778.2 million from $613.2 million.

Having weathered this first year of the competition storm, company officials said during their earnings call that they are optimistic about maintaining a dominant slice of the hereditary cancer testing pie moving forward, with myRisk leading the way.

According to Meldrum, the hereditary cancer testing field now recognizes that the future is multiplex panels like myRisk. "We believe this movement will greatly improve Myriad's already strong competitive position in the hereditary cancer market," he said.

Capone highlighted a recent study providing a new estimate of the lifetime risk conferred by mutations in the gene PALB2 for women with family history of breast cancer. The study, led by researchers at the University of Cambridge found that PALB2 mutations fall just behind BRCA1 and BRCA2 in terms of how much they elevate cancer risk, and supported the clinical need to test women for PALB2 in addition to BRCA1/2.

"We believe this data strongly conveys the importance of a gene panel-based approach with hereditary testing," Capone said.

Myriad's myRisk, like other large sequencing panels for hereditary cancer, includes PALB2 as well as other genes that confer varying risk for familial cancers.

Myriad launched myRisk in September 2013 initially with a small group of early access customers. According to Capone, the company is planning a full commercial launch of myRisk this fall. It then expects to fully convert all its comprehensive BRACAnalysis and other single-gene hereditary cancer testing customers to the myRisk panel by the summer of 2015, continuing BRACAnalysis only in the companion diagnostic setting thereafter.

The company's hereditary cancer tests contributed $168.4 million in the fiscal fourth quarter, three percent more than in the same quarter of 2013. Myriad's BRACAnalysis made up $107.4 million of that total, and the company's newer next-generation sequencing-based myRisk hereditary cancer panel, which it launched in September 2013 through an early access program, contributed $27.3 million. (For more details on Myriad's Q4 and FY 2014 results, see this article published on GenomeWeb).

Though myRisk represented only 15 percent of the company's total hereditary cancer testing in Q4 this year, Capone said that the firm ended the quarter with orders for myRisk representing closer to 30 percent of its hereditary cancer test volume.

Capone also noted that Myriad currently has long-term contracts for myRisk pricing for more than 80 million covered lives.

During its fiscal fourth quarter, Myriad signed a three-year contract with the national Blue Cross and Blue Shield Association, establishing pricing for myRisk. The company said it has already seen this contract accepted by some but not all BCBS member organizations, and Capone said that the firm is working on growing acceptance of this contract among other BCBS members, as well as increasing its long-term contracts for myRisk among other payors.

Despite new competition in the hereditary cancer testing market after the Supreme Court's decision with regard to Myriad's BRCA patent claims last year, Capone said Myriad still maintains a 92 percent share of the hereditary cancer testing market, and expects its position to further stabilize throughout 2015, especially as the company transitions its testing to myRisk.

Meldrum said during the call that Myriad believes it has an advantage over companies offering other hereditary cancer panels. For one, he said, the myRisk test leads the market in turnaround time, returning results in weeks, rather than months. According to Capone, the company's goal is to further reduce that turnaround time to about 10 days by the end of its next fiscal year.

Meldrum also highlighted the company's private database of mutations, which he said is "rapidly expanding" as Myriad continues to classify the other genes in the myRisk panel in addition to the large amounts of data it has already amassed on the BRCA genes.

He added that the company projects that it will test over 100,000 patients with myRisk in 2015.

Though the bump in revenue Myriad enjoyed in the previous year's fourth quarter as a result of celebrity publicity — what some have dubbed the 'Angelina Jolie Effect' — has deflated, Capone said that Myriad expects to benefit from "continued patient and physician awareness as a result of increased competition."

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