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Roche Receives FDA Approval for VENTANA ALK (D5F3) CDx Assay to Identify Lung Cancer Patients Eligible for Treatment with Roche’s ALECENSA (alectinib)

Roche recently announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to 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 FDA-approved as a companion diagnostic for ALECENSA.

Ventana Companion Diagnostics CAP/CLIA lab launches new Robust Prototype Assays

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced the launch of three new companion diagnostic robust prototype assays (RPAs) for the detection of biomarkers PSMA, MDM2 and FGFR, offering biotech and pharmaceutical companies more options in exploring novel treatment options for patients with cancer. The new assays bring the company’s CAP/CLIA testing menu to almost 400, nearly 100 of which are RPA assays and the remainder are IVD approved Ventana tests.

Ventana Receives FDA Clearance for Estrogen Receptor (ER) Image Analysis and Digital Read Application for Breast Cancer

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Companion Algorithm ER (SP1) image analysis algorithm used with the VENTANA iScan Coreo scanner running Virtuoso software. With this clearance, Ventana is now the only company in the industry offering a comprehensive portfolio of FDA-cleared image analysis algorithms and digital read applications for the five key immunohistochemistry (IHC) breast markers.

Ventana to Partner with Incyte on the Development of Companion Diagnostic Tests

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced that it has entered into an agreement with Incyte Corporation to collaborate on the development of companion diagnostic tests for Incyte’s oncology drug programs, beginning with the Incyte IDO1 inhibitor program. As part of the agreement, Ventana will support Incyte’s personalized medicine healthcare strategies for cancer drug development using its vast expertise in companion diagnostics, immunohistochemistry technology platforms, and worldwide customer support network.