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Myriad Discusses Outlook for its Burgeoning CDx Business Following Lynparza Approval

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NEW YORK (GenomeWeb) – Delays in reimbursement in Europe for the PARP inhibitor Lynparza was one of the factors that led Myriad Genetics to readjust its revenue guidance downward for Fiscal Year 2015, company officials said during an earnings call on Tuesday.

Myriad sharply decreased the revenue guidance to a range of $730 million to $740 million from a previous range of $800 million to $820 million. Myriad CEO Peter Meldrum attributed the $70 million adjustment to a number of factors, including delays in receiving private insurance coverage for the rheumatoid arthritis test Vectra DA, a delay in Medicare reimbursement for the Prolaris prostate cancer test, and the timing of certain contracts with pharma and for clinical services.

The company reported that its second quarter revenues declined by 10 percent, from $204.1 million in Q2 2014 to $184.4 million in Q2 2015. The decline, according to the company, was because in the year-ago quarter revenues were bolstered by the news that actress Angelina Jolie had gotten a double mastectomy based on the results of her BRCA genetic test.

Meldrum also mentioned on the call that AstraZeneca, the maker of Lynparza, has withdrawn its application for the drug to the UK's Cancer Drugs Fund. AstraZeneca had applied to the CDF for expedited review of Lynparza. In mid-January, the NHS decided to stop providing more than 20 drugs on CDF's list. However, a number of new personalized cancer drugs remain on the list, such as Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine) for HER2-targeted breast cancer.

AstraZeneca is now awaiting a recommendation from the National Institute for Health and Care Excellence to the UK's NHS. "That certainly had an impact both on our international revenues and our guidance," Meldrum said. Myriad markets the Tumor BRACAnalysis CDx as the companion diagnostic for Lynparza in Europe. With EMA approval for Lynparza, Myriad garnered CE self certification for the tumor version of the CDx in Europe.

Meldrum clarified that the delay in reimbursement is not due to lack of coverage of the companion diagnostic. "We have reimbursement for our tumor BRACAnalysis CDx … and so that won't delay revenues from that standpoint," he said. The guidance factors in the delay in getting reimbursement for Lynparza in Europe, Meldrum explained. Once Lynparza garners reimbursement in the territory, Meldrum said that revenue from CDx sales should bolster Myriad's international business.

In the US, the FDA in December approved Lynparza as a treatment for advanced ovarian cancer patients with BRCA mutations and Myriad's germline BRACAnalysis as the companion diagnostic that can identify the right patients for the drug. The drug is the first PARP inhibitor to be approved by the FDA, and BRACAnalysis is the first BRCA test to garner the agency's okay. Meldrum noted during the call, however, that the original germline version of the test (the FDA-approved version) would miss more than one-third of the ovarian cancer patients with BRCA mutations who could potentially benefit from Lynparza.

Mark Capone, president of Myriad Genetic Laboratories, said during the call that since the approval of the drug and CDx, there has been a "noticeable uptick" in the number of ovarian cancer patients who were "coming into the laboratory" for testing.

He estimated there are a total of 40,000 survivors who have been diagnosed with the ovarian cancer. Out of this group, 25 percent have been previously tested for BRCA mutations. As such, 75 percent of that 40,000 group "would be appropriate for testing so that we can discern whether or not they might be eligible for Lynparza," Capone said.

Added to that are ovarian cancer patients newly diagnosed with the disease, which also represent a market for BRACAnalysis CDx. "Our physicians will want to know their BRCA status, so that when they eventually become eligible for Lynparza, they can immediately receive that drug," he noted.

Meldrum noted during the call that garnering FDA approval for BRACAnalysis as a companion diagnostic was a "substantial" investment of time and resources. "FDA approval is the highest level of clinical validation in the US and significantly differentiates the quality of our laboratory when compared to our competitors," Meldrum said. "Myriad has developed the capability to gain FDA approval of highly complex tests as one of our core competencies. And this ability will be increasingly important as the regulatory environment evolves in the laboratory industry."

The FDA issued draft guidelines on regulation of lab-developed tests in October, in which the agency noted that companion diagnostics used to determine which patients should get a drug are high-risk tests that require pre-market review. The deadline for the public comment period on the draft guidance was Feb. 2.

BRACAnalysis first came on the market in 1996 as an LDT for assessing the risk of hereditary breast and ovarian cancer. In recent years, Myriad decided to move its entire hereditary cancer testing business to a next-generation sequencing based test, called myRisk Hereditary Cancer, and use BRACAnalysis as a companion diagnostic for guiding treatment decisions for PAPR inhibitors and DNA-damaging agents.

Myriad has partnerships with a number of drugmakers advancing such agents and using BRACAnalysis to characterize patients' tumors in their drug trials. Meldrum noted that this initial approval for BRACAnalysis from the agency, and the fact that Myriad could effectively navigate the regulatory process, will be important to its pharma partners.

The company's CDx portfolio also includes the NGS-based homologous recombination deficiency (HRD) test, dubbed myChoice HRD, and a number of drugmakers are also investigating this test in their drug trials. At the San Antonio Breast Cancer Symposium in December, Myriad presented data on the test.

In one study, researchers used the test to identify a subset of early-stage triple-negative breast cancer (TNBC) patients who responded to platinum-based therapies. In another study involving advanced TNBC patients, researchers reported that BRCA mutation status gauged by Myriad's BRACAnalysis test was predictive of carboplatin benefit over docetaxel, but using just the HRD test wasn't similarly predictive of treatment response.

Myriad said it is planning an early-access launch of the myChoice HRD test later this summer.

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