The FDA’s approval on Thursday for BioMarin’s Roctavian gene therapy for severe hemophilia A came with a second approval attached: for a companion diagnostic that can identify which patients may be ...

The FDA approved the Oncomine Dx Target Test for identifying HER2-mutant NSCLC patients eligible for Hernexeos, an oral tyrosine kinase inhibitor. Hernexeos offers a new treatment option for ...

Pharmaceutical companies are keen to have a stake in the personalized medicine market, viewed as a growing trend in the future of healthcare and a significant source of life science innovation. As ...

TruSight Oncology Comprehensive is the first US FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims The 500+ gene biomarker test advances ...

Seattle's NanoString Technologies ($NSTG) stands to make up to $45 million if it can come up with a successful companion diagnostic test to screen for a subset of ...

(RTTNews) - Guardant Health, Inc. (GH) said Thursday that the U.S. Food and Drug Administration has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic for patients with BRAF ...

The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) ...

The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer ...

FDA approved a PD-L1 companion test to identify patients with ovarian, fallopian tube or primary peritoneal cancer who may receive Keytruda. The U.S. Food and Drug Administration (FDA) has approved PD ...

Approval reinforces Myriad’s leadership in comprehensive HRD testing and establishes MyChoice CDx as the only FDA-approved companion diagnostic for Zejula in the United States SALT LAKE CITY, March 17 ...

Oro Valley-based Ventana Medical Systems, part of of Swiss drug giant Roche, has won FDA approval of a companion test for a drug to treat non-small cell lung cancer. The U.S. Food and Drug ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) announced today that the U.S. Food and Drug Administration (FDA) has approved Agilent Resolution ctDx FIRST as a companion ...