The expanded indication helps identify patients with metastatic gastroesophageal adenocarcinoma eligible for targeted therapy.
The Food and Drug Administration (FDA) approved the expanded use of two companion diagnostic tests from Roche to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma (GEA).
The approval applies to the PATHWAY HER2 (4B5) Rabbit Monoclonal Primary Antibody test and the VENTANA HER2 Dual ISH DNA Probe Cocktail. These tests are now indicated to assess HER2 status in patients with gastric, gastroesophageal junction, and esophageal adenocarcinoma. The results help clinicians determine eligibility for ZIIHERA (zanidatamab-hrii), a HER2-targeted treatment developed by Jazz Pharmaceuticals.
GEA includes a group of aggressive cancers originating in the gastrointestinal tract. These cancers are often diagnosed at advanced stages and represent the fifth and sixth leading causes of cancer deaths worldwide, according to the company.
“GEA can be a difficult diagnosis for patients to face, with most cases only being detected once the disease has progressed to an advanced stage,” says Laura Apitz, head of pathology lab at Roche Diagnostics, in a release. “By adding GEA to the approved indications for our widely-available HER2 assay, we expand the patient population eligible for targeted therapy and potentially improve patient outcomes.”
This is the first time a test has been approved to determine HER2 status specifically in esophageal cancer. Previously, patients with this form of the disease lacked an approved diagnostic path to access targeted therapies.
The PATHWAY HER2 (4B5) test is an immunohistochemistry assay designed for use on the automated VENTANA BenchMark slide staining platform. The VENTANA HER2 Dual ISH DNA Probe Cocktail uses dual-color technology to detect HER2 gene amplification, allowing pathologists to compare HER2 status with other markers within the same case.
Two regimens containing ZIIHERA are currently FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA. Roche says the tests provide laboratories and pathologists with actionable insights to support personalized treatment approaches across multiple cancer types.
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