FDA clears Ventana ALK CDx assay to identify lung cancer patients

15 June 2015 (Last Updated June 15th, 2015 18:30)

The US Food and Drug Administration (FDA) has authorised Roche Group subsidiary Ventana Medical Systems to use its ALK (D5F3) CDx assay as a companion diagnostic to identify lung cancer patients for Pfizer's FDA approved targeted therapy Xalkori (crizotinib).

ALK assay

The US Food and Drug Administration (FDA) has authorised Roche Group subsidiary Ventana Medical Systems to use its ALK (D5F3) CDx assay as a companion diagnostic to identify lung cancer patients for Pfizer's FDA approved targeted therapy Xalkori (crizotinib).

Xalkori is an oral first-in-class ALK inhibitor, which is indicated to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK) positive as detected by an FDA approved test.

With FDA Class III approval, ALK immunohistochemistry (IHC) testing can be used on Ventana BenchMark IHC instruments that provide better test results with a binary and straightforward scoring method.

"With FDA Class III approval, ALK immunohistochemistry (IHC) testing can be used on Ventana BenchMark IHC instruments that provide better test results with a binary and straightforward scoring method."

The test was granted CE-IVD status in Europe in 2012, while approval from the Chinese Food and Drug Administration (CFDA) was obtained in 2013.

Roche Tissue Diagnostics (Ventana) president Daniel Zabrowski said: "Traditional fluorescent in-situ hybridisation (FISH) ALK testing methods have required patients to wait weeks before receiving their ALK mutation status.

"With an approved ALK IHC test, physicians and their ALK positive patients now have the option to learn their ALK status and start an ALK-targeted therapy within days."

Ventana Companion Diagnostics medical director Mary Padilla said: "The test provides physicians and patients a fast and accurate method to identify ALK protein expression, and clinicians can be confident knowing that our FDA approval is based on data resulting from collaboration between Ventana and Pfizer.

"Ventana used the Ventana ALK (D5F3) CDx assay and scoring method to retrospectively test patient samples from Pfizer-sponsored clinical trials and demonstrated that the test is effective in identifying patients with ALK-positive NSCLC who may benefit from treatment with Xalkori (crizotinib)."

Companion diagnostics tests are designed to confirm the presence of a specific biomarker to help physicians in selecting effective therapies for their patients, based on the individual characteristics of each person.


Image: The FDA Class III approval makes ALK IHC testing widely accessible on Ventana BenchMark immunohistochemistry instruments worldwide. Photo: courtesy of Ventana Medical Systems.