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ChipDx Eyeing FDA Submission for Breast Cancer Relapse Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – ChipDx today said that it plans to file for US regulatory approval of its test for breast cancer recurrence.

ChipDx Founder and Chief Scientific Officer Ryan van Laar told GenomeWeb Daily News that the company has received pre-IDE evaluations for one of BreastGeneDx's signatures from the US Food and Drug Administration's Center for Devices and Radiological Health and is looking for partners to "assist in pursuing the next stage of the assay validation/FDA submission process."

The firm, he said, also has received pre-IDE evaluation for one signature from FDA for its Cancer GeneDx test to detect cancer of unknown origin. ChipDx has also developed ColonGeneDx for predicting recurrence and survival of patients with colon cancer, which is available for research-use only.

Current commercialization efforts are focused on the breast cancer test. The 200 gene signature test is for the prediction of breast cancer relapse and was designed to be used on the Affymetrix GeneChip microarray system. It is currently available online for research-use only.

The New York-based molecular diagnostics firm said that a recent study published in the Journal of Molecular Diagnostics that analyzed whole-genome profiles of 477 breast cancer patients suggested BreastGeneDx is "the strongest predictor of outcome in each validation series, compared to other methods of predicting breast cancer prognosis."

In untreated node-negative patients the test achieved 88 percent sensitivity and 44 percent specificity for 10-year recurrence-free survival. Positive and negative predictive values were 32 percent and 92 percent, respectively, ChipDx said.

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