HER-2 Test Cleared by FDA to Select Herceptin Therapy Candidates

NEW YORK (Reuters Health) Jan 10 – Abbott Laboratories said Thursday that it has received US Food and Drug Administration (FDA) clearance for its PathVysion HER-2 DNA Probe Kit to help determine if women with aggressive metastatic breast cancer are good candidates for Genentech's monoclonal antibody therapy, Herceptin.

PathVysion is already approved to give women with overexpression of the HER-2 gene a prognosis and to determine suitability of therapy with the chemotherapy drug adriamycin, said Abbott spokesman Don Braakman.

Oncologists may have been using PathVysion off-label to select candidates for therapy with Herceptin, but the FDA approval "provides another level of comfort for them to use it as a primary test," he told Reuters Health.

"With this third approval, we expect PathVysion to become the most widely used HER-2 test," he added.

The product has not been approved outside the US for selecting patients for Herceptin therapy.

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