Myriad Genetics Spikes on FDA Approval of Pancreatic Cancer Diagnostic Test

The Food and Drug Administration approves BRACAnalysis CDx, Myriad Genetics' metastatic pancreatic cancer diagnostic tool for patients who are eligible for treatment with Lynparaza, a drug marketed by AstraZeneca.
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Myriad Genetics  (MYGN) - Get Report was rising Monday after the medical diagnostic company announced that the Food and Drug Administration approved BRACAnalysis CDx, its metastatic pancreatic cancer diagnostic tool for patients who are eligible for treatment with Lynparaza, a drug marketed by AstraZeneca  (AZN) - Get Report.

Myriad shares were rising 8.3% to $29 in premarket trading Monday.

Pancreatic cancer is the third most common cause of cancer-related death in the U.S., according to a press release from Myriad Genetics.

“The new FDA approval and recently updated NCCN guidelines support physicians who order testing at the time of diagnosis. The sooner we can identify patients with germline BRCA mutations, the better chance they will have to benefit from precision therapies,” said Myriad Genetics Oncolocy President Nicole Lambert.

Myriad Genetics discovers and commercializes molecular diagnostic tests to determine the risk of developing disease, accurately diagnose disease, asses the risk of progression and guide treatment decisions.

“The approval of the BRACAnalysis CDx test for patients with pancreatic cancer highlights our shared vision and long-standing collaboration with Myriad to advance precision medicine for patients in need of new treatments,” said Ruth March, senior vice president and head of Precision Medicine, Oncology R&D, AstraZeneca.

Myriad Genetics and AstraZeneca have been collaborating since 2007 as part of a diagnosis and treatment partnership featuring Myriad’s diagnostic tools and AstraZeneca's PARP inhibitor Lynparaza.

“We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for people with metastatic pancreatic cancer, and we are excited to expand the use of BRACAnalysis CDx as a companion diagnostic test,” Lambert said.