Foundation Medicine’s Lung Cancer Diagnostic Approved

Cambridge, Mass.-based Foundation Medicine has received the FDA’s approval for its FoundationOne CDx diagnostic device for lung cancer.

The product is intended as a companion diagnostic for Takeda Oncology’s oncology drug Alunbrig (brigatinib), which is approved for treatment of adults with anaplastic lymphoma kinase-positive metastatic nonsmall-cell lung cancer.

FoundationOne CDx is a tissue-based genomic test that can detect this type of cancer and identify patients who may be appropriate for treatment with Alunbrig.