regulatory approval

In Europe, Blueprint will commercialize the drug first in Germany as a treatment for advanced GIST patients with a PDGFRA D842V mutation.

The test detects the presence of two biomarkers within a single cell associated with HPV infections that can progress to cervical cancer.

Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.

The agency approved the drug for metastatic, RET fusion-positive, non-small cell lung cancer patients who are identified by an FDA-approved test.

Amoy will develop its AmoyDx Pan Lung Cancer PCR Panel (9-in-1 Plus) as a companion diagnostic test for Haihe's MET kinase inhibitor Glumetinib.

The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.

The drugmaker said it is working with centers of excellence in Canada to set up companion diagnostic testing to identify patients with PIK3CA mutations.

The assay provides comprehensive genomic information to oncologists from a blood draw, using targeted next-generation sequencing of circulating cell-free DNA.

The commission took the earlier CHMP recommendation to approve the treatment based on the positive results from the Phase III SOLAR-1 trial.