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CDx development

The firms plan to use Thermo Fisher's Oncomine Dx Target test to identify cancer patients with RET alterations who might benefit from Lilly's LOXO-292.

The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.

Caris will use its whole-transcriptome sequencing assay and Molecular Intelligence Trials service to identify patients for a phase II clinical trial.

The test will be used to identify men with metastatic, castrate-resistant prostate cancer and germline BRCA mutations who are enrolled in a study for olaparib.

Qiagen and Foundation Medicine will develop tissue- and plasma-based companion tests to identify best responders to the PI3K inhibitor alpelisib

The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.

The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.

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 so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments. 

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.

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