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The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

At least one drugmaker is planning to submit for FDA approval of its KRAS inhibitor based on data from Phase I/II, single-arm trial in heavily pretreated lung cancer patients.

Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.

Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.

CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.

For heavily pretreated ovarian cancer patients, doctors will now have to weigh their HRD status in the context of an increasingly complex backdrop of biomarker information.

The vaccine targets multiple proteins that are overexpressed by breast tumors and aims to prevent the disease from developing.

The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.

Diaceutics is projecting that FDA will soon approve more personalized drugs than all-comer drugs, but absent changes in diagnostics strategies many patients won't receive them.

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