Myriad Genetics (MYGN) Announces Submission of BRACAnalysis CDx Test for Approval in Japan
- Donald Trump Sworn in as 45th U.S. President
- Wall Street ends higher as Trump becomes president
- Walgreens Boots Alliance (WBA) Said to Face Antitrust Concern for Rite Aid (RAD) Fix - Bloomberg
- Bristol-Myers Squibb (BMY) Says It Won't Pursue Accelerated U.S. Regulatory Pathway for Opdivo Plus Yervoy in Lung Cancer
- Apple (AAPL) Sues Qualcomm (QCOM) Over Patent Royalties in Antitrust Case - Bloomberg
Get inside Wall Street with StreetInsider Premium. Claim your 2-week free trial here.
Myriad Genetics, Inc. (Nasdaq: MYGN) announced that it will submit its BRACAnalysis CDx test for approval by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in parallel with the PMDA review of AstraZeneca’s novel PARP inhibitor, olaparib.
BRACAnalysis CDx is the leading genetic test to identify patients who are likely to benefit from treatment with olaparib, which is a novel PARP inhibitor that targets tumor DNA repair pathway deficiencies to preferentially kill cancer cells.
"BRACAnalysis CDx launched precision medicine for ovarian cancer patients by identifying patients more likely to respond to PARP inhibitors," said Mark C. Capone, president and CEO, Myriad Genetics. "As a global leader in personalized medicine, Myriad is committed to providing the highest quality molecular tests in the fight against the world's most challenging diseases, including breast and ovarian cancers."
Today’s announcement builds on a long-term companion diagnostic collaboration with AstraZeneca that began in 2007. In December 2014, the U.S. Food and Drug Administration (FDA) approved BRACAnalysis CDx to identify ovarian cancer patients who may be appropriate for treatment with Lynparza™ (olaparib). It was the first time the FDA had approved a laboratory developed test (LDT) under the premarket approval application process.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Perma-Fix (PESI) Names S. Robert Cochran to Board of Directors
- Morgan Stanley, Citi plan Brexit job moves: sources
- Apple files $1 billion lawsuit against chip supplier Qualcomm
Create E-mail Alert Related CategoriesCorporate News, Management Comments
Related EntitiesDefinitive Agreement
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!