The FDA has approved Foundation Medicine's FoundationOne CDx, the first-of-a-kind comprehensive companion diagnostic test for solid tumors. The test looks for hundreds of cancer genes, providing ...

The guidance notes that it could be possible for CDxs that are "adequately validated to detect biomarker(s) of interest and to identify appropriate patients for treatment" to be "indicated more ...

Maybe it takes a certain set of experiences like going to medical school and then having cancer, or geekiness, to get excited by spending two days at a biotech conference on companion diagnostics, CDx ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved a blood-based companion diagnostic for osimertinib for use in certain patients with non–small ...

(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 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 ...

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 ...

Assay will predict which patients are best suited to the therapeutic that targets the steroid sulfatase enzyme. bioMérieux agreed to develop a companion test for Ipsen’s Phase I breast cancer drug ...

After decades of research and theoretical debates, it seems precision oncology is finally falling into place. At the end of May, FDA triggered a seismic shift in the field with its decision to approve ...

bioMerieux and Ipsen announced that they have signed an agreement by which bioMerieux will develop a companion test for a new breast cancer drug undergoing clinical evaluation by Ipsen. The ...