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Dako Gets FDA OK for HER2 Tests for Gastric, Stomach Cancer

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Dako has received clearance from the US Food and Drug Administration to expand the intended use of its HercepTest and HER2 FISH pharmDx Kit to include patients with metastatic gastric or gastroesophageal junction adenocarcinoma (stomach cancer).

The tests are used to help guide treatment for patients for whom Herceptin (trastuzumab) is being considered. The tests were cleared for the indication along with approval for Genentech's Herceptin in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic cancer of the stomach or gastroesophageal junction in men and women who have not received prior medicines for their metastatic disease.

Dako had announced in August 2009 that it was working with Genentech to submit to the FDA two genetic tests — the immunohistochemistry-based HercepTest and the HER-2 FISH pharmDx test — as companion diagnostics for Herceptin for the treatment of gastric cancer. It had filed for FDA clearance of the test earlier this year for the stomach cancer indication.

According to Dako, over one million new cases of stomach cancer are diagnosed each year, and the disease is the second most-common cause of cancer-related deaths globally.

The HercepTest and HER2 FISH pharmDx Kit already have the CE Mark in Europe.