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Myriad Presents Data On BRACAnalysis CDx(TM) And HRD(TM) At 2014 ASCO Meeting

SALT LAKE CITY, May 30, 2014 (GLOBE NEWSWIRE) -- 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 BRAC Analysis 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 BRAC Analysis CDx in Metastatic Breast Cancer Patients

At this week's ASCO meeting, Myriad will present data supporting BRAC Analysis 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 BRAC Analysis 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 BRAC Analysis 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 BRAC Analysis 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 Phase/Indications Timeline Myriad Test
AstraZeneca olaparib Phase 3 – platinum sensitive relapsed ovarian cancer Expect U.S. FDA and EMA approval for platinum sensitive ovarian cancer in BRAC Analysis CDx™
    Phase 3 – first line maintenance therapy for ovarian cancer CY15. Expect to file with the FDA for breast cancer in CY16.  
    Phase 3 – metastatic breast cancer    
    Phase 3 – neoadjuvant breast cancer    
    Phase 3 – adjuvant breast cancer    
Biomarin BMN-673 Phase 3 – metastatic breast cancer NA BRAC Analysis CDx™
AbbVie veliparib Phase 3 – neoadjuvant treatment of triple negative breast cancer NA BRAC Analysis CDx™
Tesaro niraparib Phase 3 – platinum sensitive ovarian cancer NA BRAC Analysis CDx™
    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."

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