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Myriad Genetics Says Will Present Data on BRACAnalysis CDx(TM), HRD(TM) at 2014 ASCO Meeting


Myriad Genetics, Inc. (Nasdaq: MYGN), a global leader in molecular diagnostics, announced the presentation of new data at the American Society of Clinical Oncology (ASCO) meeting this week that supports the clinical efficacy of its BRACAnalysis CDx™ and HRD™ tests in predicting platinum based therapy response for breast cancer patients. Additionally, the company is providing an update on key commercial milestones that underscore its commitment to the field of companion diagnostics.

"Myriad is committed to advancing the science of companion diagnostics and is currently working with approximately 20 different pharmaceutical companies on companion diagnostic programs," said Mark Capone, president of Myriad Genetic Laboratories. "We believe the future of pharmaceuticals depends on providing therapeutics to patients that are tailored to their individual genetic makeup, and we are investing substantial resources to maintain our global leadership position in this field."

Data on BRACAnalysis CDx in Metastatic Breast Cancer Patients

At this week's ASCO meeting, Myriad will present data supporting BRACAnalysis CDx's ability to predict platinum response in metastatic breast cancer patients. In a trial of 86 patients, the response rates to platinum based therapies (carboplatin and cisplatin) for patients with deleterious mutations detected by BRACAnalysis CDx (the Company's proprietary companion diagnostic test for deleterious mutations and large rearrangements in the BRCA1 and BRCA2 genes) was 54.5 percent compared to only 19.7 percent in the non-carrier group. These data underscore the ability of BRACAnalysis CDx to predict patient response to platinum based therapies in a patient population characterized by low overall response rates.     

Myriad is making substantial progress toward the commercialization of BRACAnalysis CDx for PARP inhibitors and several of Myriad's commercial pharmaceutical partners have recently made major announcements on the advancement and expansion of their PARP inhibitor programs. Below is a table summarizing the announced, late-stage clinical trials by commercial partners in which Myriad is providing the companion diagnostic test in support of the drug.

          Company Drug Clinical Trial Timeline Myriad Test Phase/Indications AstraZeneca Phase 3 – platinum Expect U.S. FDA and olaparib sensitive relapsed EMA approval for BRACAnalysis ovarian cancer platinum sensitive CDx™ ovarian cancer in   Phase 3 – first CY15. Expect to file   line maintenance with the FDA for   therapy for ovarian breast cancer in cancer CY16.     Phase 3 – metastatic     breast cancer     Phase 3 – neoadjuvant     breast cancer     Phase 3 – adjuvant     breast cancer Biomarin BMN-673 Phase 3 – metastatic NA BRACAnalysis breast cancer CDx™ Phase 3 – neoadjuvant BRACAnalysis AbbVie veliparib treatment of triple NA CDx™ negative breast cancer Phase 3 – platinum BRACAnalysis Tesaro niraparib sensitive ovarian NA CDx™ cancer     Phase 3 – metastatic     breast cancer

"In the area of cancer, we are seeing significant progress by our pharmaceutical partners in the advancement of PARP inhibitors toward commercialization in a variety of cancer types and we are excited to be providing best-in-class diagnostics in support of these important therapeutics," said Capone. "Myriad is uniquely positioned as a global diagnostic company to provide these highly complex tests with the accuracy and turnaround times required to have a positive impact on patient care."

New Data on Myriad's Proprietary HRD Test Supports Planned Commercial Launch in FY15

Myriad also will present data looking at the ability of the Company's proprietary HRD tumor test in terms of its ability to predict response among triple negative breast cancer patients. The combination of Myriad's three HRD assays including Loss of Heterogyzosity (LOH), Telomere Allelic Imbalance (TAI), and Large-Scale State Transition (LST) were highly correlated with patient response rates. These data further highlight the likely utility of HRD as a more comprehensive companion diagnostic for DNA damaging agents.

In addition, Myriad announced a new 160 patient randomized study evaluating HRD as a biomarker for prediction of cisplatin and paclitaxel response in triple negative breast cancer patients at diagnosis. This is one of several ongoing clinical trials Myriad is conducting looking at the predictive power of HRD in guiding platinum based therapy. Myriad plans to present data later this year on HRD that will support an early access launch of the test in triple negative breast cancer patients in late fiscal year 2015.

"High HRD scores have been shown in early research to be highly correlated with response rates to DNA damaging agents such as platinum based therapies," said Jerry Lanchbury, chief scientific officer at Myriad Genetics. "We believe that, with further validation, the HRD test has the potential to become the gold standard diagnostic to identify patients who have lost DNA repair function and are most suitable for this class of therapeutics." 

Posted-In: News FDA Press Releases


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