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The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
The company announced agreements to use the Oncomine Dx Target Test in drug development programs with Daiichi Sankyo, Takeda, and Spectrum Pharmaceuticals.
The drugmaker will use Myriad's expanded molecular diagnostic panel to evaluate best responders to a combination of Lynparza and Avastin in clinical trials.
The initial FDA approval of Thermo Fisher's NGS panel test for personalizing cancer treatment may allow rapid expansion to new indications.
The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments.
Analyzing utilization data, Diaceutics found that issues around 13 genetic tests prevent around 78,000 patients from getting personalized, targeted treatments each year.
The agency approved Novartis' Rydapt for AML patients with FLT3 mutations, who will be identified by Invivoscribe's LeukoStrat CDx.
Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.