Pharmaceutical company Roche (SIX:RO) (SIX:ROG) (OTCQX:RHHBY) reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for the VENTANA ALK (D5F3) CDx Assay to identify ALK-positive non-small cell lung cancer (NSCLC) patients.

The company said the VENTANA ALK (D5F3) CDx Assay can identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Roche medicine ALECENSA (alectinib). The VENTANA ALK (D5F3) CDx Assay is the only test US FDA-approved as a companion diagnostic for ALECENSA.

Additionally, the company's VENTANA ALK (D5F3) CDx Assay is available for use on the Roche BenchMark XT or BenchMark ULTRA IHC/ISH slide staining systems.

Under the company's clinical studies, the VENTANA ALK (D5F3) CDx Assay has shown to identify more patients that will benefit from an anti-ALK target therapy than fluorescent in situ hybridization (FISH) testing. It is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument.

In conjunction, the company's VENTANA ALK (D5F3) CDx Assay test acts as an aid in identifying patients eligible for treatment with XALKORI (crizotinib), ZYKADIA (ceritinib) or ALECENSA (alectinib). It is an important biomarker found in NSCLC and its detection and inhibition can help shrink tumors in some ALK-positive patients.