Corporate Member Update: FoundationOne®CDx Receives FDA-Approval as a Companion Diagnostic for ALUNBRIG® (brigatinib) to Identify Patients with ALK positive Metastatic Non-Small Cell Lung Cancer

We have received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for ALUNBRIG® (brigatinib), which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. FoundationOne CDx, the only FDA-approved tissue-based comprehensive genomic profiling (CGP) test, is now able to detect ALK+ mNSCLC and identify patients who may be appropriate for treatment with ALUNBRIG which is approved as a first-line or later-line therapy.

Read the full press release for details.