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FDA-approved companion diagnostic

Ventana ALK (D5F3) CDx Assay

Qualitative IHC assay using anti-ALK (D5F3) on VENTANA BenchMark to detect ALK protein in FFPE NSCLC tissue and support targeted therapy decisions.

IVD-developed CDxMethod: IHCSpecimen: Tissue (FFPE)Biomarker: ALK protein expression
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P140025
Supplements
S005, S006, S014
Manufacturer
Ventana Medical Systems, Inc. (Roche Diagnostics)
Approval date
June 12, 2015
Test specifications
Methodology
IHC
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
ALK protein expression
What this test is

VENTANA ALK (D5F3) CDx Assay is an FDA-approved, qualitative immunohistochemistry test that uses rabbit monoclonal anti-ALK, clone D5F3, with OptiView DAB IHC Detection and Amplification on VENTANA BenchMark instruments to detect ALK protein expression in FFPE NSCLC tissue. It classifies tumors as ALK positive or negative to guide ALK-directed treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)ALKprotein expressionALECENSA, LORBRENA, XALKORI, ZYKADIA

IVD Manufacturer

Ventana Medical Systems, Inc. (Roche Diagnostics)

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Order this test

If your organization is connected to Casandra, you can place an electronic order forVentana ALK (D5F3) CDx Assay directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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