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FDA-approved companion diagnostic

Ventana HER2 Dual ISH DNA Probe Cocktail

Dual-color in situ hybridization assay that measures HER2 gene amplification relative to chromosome 17 in FFPE breast and gastric cancer tissue on VENTANA BenchMark instruments.

IVD-developed CDxMethod: ISHSpecimen: Tissue (FFPE)Biomarker: HER2 gene amplification
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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
P190031
Supplements
Manufacturer
Ventana Medical Systems, Inc. (Roche Diagnostics)
Approval date
July 28, 2020
Test specifications
Methodology
ISH
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
HER2 gene amplification
What this test is

VENTANA HER2 Dual ISH DNA Probe Cocktail is an FDA-approved, dual-color chromogenic in situ hybridization assay that uses HER2 and chromosome 17 DNA probes to assess HER2 gene amplification in FFPE breast and gastric or gastroesophageal junction cancer tissue. Performed on VENTANA BenchMark instruments, it reports HER2/Chr17 ratios to classify tumors as HER2-negative or HER2-amplified for treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerERBB2 (HER2)gene amplificationHERCEPTIN

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 HER2 Dual ISH DNA Probe Cocktail 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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