Roche has secured CE IVDR approval for its Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay鈥檚 label expansions, marking advancements in the identification of HER2-ultralow breast cancer and biliary tract cancer patients.
The diagnostic test is designed to assess HER2 receptor protein expression, a key predictive biomarker for determining patient eligibility for HER2-targeted therapies.
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It is claimed to be the first companion diagnostic approved for identifying patients with HR-positive metastatic breast cancer classified as HER2-ultralow, who may qualify for treatment with Enhertu (trastuzumab deruxtecan).
Enhertu is a HER2-directed antibody drug conjugate discovered by Daiichi Sankyo and is being co-marketed with AstraZeneca.
Furthermore, the test is also the first to assist in evaluating HER2-positive status in biliary tract cancer patients with an immunohistochemistry score of 3+, making them eligible for Jazz Pharmaceuticals鈥� Ziihera (zanidatamab-hrii).
It was also utilised in the DESTINY-Breast06 trial, which indicated a notable enhancement in progression-free survival for patients with HER2-low and HER2-ultralow metastatic breast cancer receiving Enhertu compared to standard chemotherapy.
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By GlobalDataRoche Diagnostics pathology lab head Jill German said: 鈥淥ur understanding of HER2 is rapidly evolving, and this expanded approval ensures our diagnostics are leading the way.
鈥淲e’re enabling clinicians to unlock personalised, life-altering treatments for patients who urgently need them.”
Previously, the test was indicated for identifying breast cancer patients eligible for HER2-targeted treatments such as Kadcyla, Herceptin, Perjeta, or Enhertu, as well as gastric cancer patients suitable for Herceptin treatment.
The assay operates in conjunction with the fully automated Ventana BenchMark slide staining instrument, standardising immunohistochemistry (IHC) processes and reducing human error.
It also reduces variability associated with manual and semi-automated IHC methods.
In July, Roche’s Elecsys pTau181 test received CE Mark approval, advancing the ability to rule out Alzheimer’s disease.
