The tests can now be used to identify HER2-positive metastatic breast cancer patients that could be eligible for Enhertu.
The US Food and Drug Administration (FDA) has approved expanded indications for Roche’s Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and Ventana HER2 Dual ISH DNA Probe Cocktail tests to aid in identifying HER2-positive metastatic breast cancer patients who may be eligible for treatment with Enhertu (trastuzumab deruxtecan).
Previously, Roche’s PATHWAY HER2 (4B5) test had been approved for identifying metastatic breast cancer patients with HER2-low and HER2-ultralow expression. With this expanded approval, the Pathway HER2 (4B5) test in combination with the Ventana HER2 Dual ISH DNA Probe Cocktail can now be used to identify patients across the full spectrum of HER2 expression for potential eligibility for Enhertu, an HER2-directed antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
“Metastatic breast cancer remains a significant challenge,” says Laura Apitz, head of pathology lab at Roche Diagnostics, in a release. “Diagnostic advances like these bring much-needed hope for patients. With this approval, our breast diagnostic portfolio can further guide therapy decisions for clinicians, enabling a more personalized approach.”
Addressing Evolving Understanding of HER2 Biology
The approval reflects advances in understanding HER2 biology, which now shows that HER2 expression exists on a continuous spectrum rather than as distinct “positive” or “negative” categories. Breast cancer represents one in four of all cancers diagnosed in women worldwide, and metastatic breast cancer poses a growing challenge, especially in younger populations where cases among women aged 25 to 39 increased by 32% between 2009 and 2015.
The Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is used in combination with the fully automated BenchMark Ultra and BenchMark Ultra Plus staining platforms. The assay standardizes all immunohistochemistry processes from baking through staining and reduces the possibility of human error. It also minimizes inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated immunohistochemistry methods.
Automated Brightfield Solution
The Ventana HER2 Dual ISH DNA Probe Cocktail assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene status. The assay is optimized for use with the Ventana Silver ISH DNP Detection Kit and the Ventana Red ISH DIG Detection Kit on the fully automated BenchMark Ultra and BenchMark Ultra Plus staining platforms.
The Ventana HER2 Dual ISH DNA Probe Cocktail assay is an enhanced version of the previous-generation test. New oligonucleotide probes and highly sensitive detection kits provide clear results to pathology labs more quickly, allowing clinicians to make treatment decisions earlier.
These diagnostics strengthen Roche’s broader breast cancer portfolio, which offers solutions that cover the full spectrum of breast cancer management, including important predictive assays.
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