Myriad Enters Companion Diagnostics Field With An FDA First
This article was originally published in The Gray Sheet
Myriad Genetics' BRCA1/2 gene testing service has been approved as a companion diagnostic to AstraZeneca's new ovarian cancer drug, an important step in the company's diversification plan and a significant milestone in FDA's oversight of laboratory-developed tests.
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Myriad is continuing its mission to expand its companion diagnostics reach by teaming up with Tesaro and Merck to evaluate their breast and ovarian cancer drugs, and expanding its partnership with Abbvie into lung cancer. .
Qiagen’s agreement Tokai Pharmaceuticals targets circulating tumor cells, and Myriad Genetics has extended its partnership with BioMarin Pharmaceutical focused on Myriad's myChoice HRD companion diagnostic.
Five and a half years after its decision to spin off its pharmaceutical business and a year and a half away from having the US Supreme Court break its monopoly on BRCA gene testing, Myriad Genetics is no longer an exception among molecular diagnostics companies. It must find its way along a more crowded path.