Investigators will use Biocept's liquid biopsy tests to detect ALK rearrangements both at baseline and to monitor treatment response and resistance mechanisms.
The Ventana assay is an immunohistochemistry-based companion diagnostic that identifies ALK-positive NSCLC patients eligible for the Novartis drug Zykadia.
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.
Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.
The IHC test was used in clinical studies that led to Zykadia's approval last week as a first-line option for metastatic NSCLC patients with ALK rearrangements.
The coverage decision limits the test to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue-based testing.
The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the EGFR gene.
Progenetics will distribute GeneStrat and Veristrat liquid biopsy tests in Israel, making Biodesix's tests available in the Middle East for the first time.
The firm's ROS1 gene fusion kit was approved as a companion diagnostic for Pfizer's Xalkori.