FDA Clears Dako's Companion Dx for Herceptin

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FDA Clears Dako's Companion Dx for Herceptin
December 13, 2011
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By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration late last month approved a Dako test for use as a companion diagnostic for determining which patients may benefit from treatment with Herceptin (trastuzumab).

The Danish cancer diagnostic firm's HER2 CISH pharmDx Kit measures copies of the HER2 gene in formalin-fixed, paraffin-embedded breast cancer tissue specimens by using a chromogenic in situ method, and results "are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients," FDA said in its approval letter to Dako.

The CISH procedure is automated on Dako's Autostainer instruments.

During the summer, FDA cleared a test made by Ventana Medical Systems, part of the Roche Group, which measures the number copies of the HER2 gene for use as a tool to determine patients who may be candidates for Herceptin, manufactured by Genentech, also a Roche company.

Dako's HercepTest and Her2 FISH pharmDx were approved by FDA last year to guide treatment of patients with Herceptin in combination with chemotherapy 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.

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