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FDA Approves Dako's CISH Companion Test for Herceptin

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Originally published Dec. 13.

The US Food and Drug Administration has approved Dako's HER2 CISH pharmDx Kit for quantitatively determining HER2 status in tumors of breast cancer patients who are considering treatment with the drug Herceptin.

The chromogenic in situ hybridization method enables simultaneous evaluation of gene amplification and tumor tissue morphology. The kit assesses HER2 status in formalin-fixed, paraffin-embedded breast cancer tissue. Dako's CISH test is automated on its Autostainer instruments.

The FDA-approved label for the HER2 CISH pharmDx Kit describes it as a companion test to determine whether a breast cancer patient is HER2-positive, and therefore should receive Roche/Genentech's Herceptin.

"Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients," the label indicates.

Ahead of the FDA approval, Dako last year launched the CISH HER2 kit in Canada, Europe, and several other countries. In a study of 365 breast cancer patients, the CISH test had 97.7 percent concordance with HER2 assessments made with fluorescence in situ hybridization-based tests. The company believes that CISH testing will be broadly adopted by pathology labs since it doesn't require the use of a fluorescence microscope.

"With the HER2 CISH pharmDx Kit … the pathologist can use a traditional bright field microscope to determine whether the patient is likely to benefit from receiving treatment with Herceptin," the company said previously.

There is at least one other FDA-approved HER2 CISH test on the market. In 2008, Invitrogen, now a subsidiary of Life Technologies, gained approval from the FDA for its SPOT-Light HER2 CISH Kit.

Dako's Herceptest and the Roche/Ventana's Pathway test are two FDA-approved immunohistochemistry assays for gauging HER2 to identify likely responders to Herceptin. Additionally, for the same indication, the agency has also approved Abbott/Vysis's FISH-based PathVysion HER-2 DNA Probe Kit.

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