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Nuclea Files for FDA Approval of Breast Cancer, Prostate Cancer Assays

This article has been updated from a previous version, which incorrectly stated that the company had filed for premarket approval of its assays.

SAN FRANCISCO (GenomeWeb News) – Nuclea Biotechnologies said on Wednesday that has filed premarket IDE filings with the US Food and Drug Administration for its breast cancer and prostate cancer assays.

The submission is for the Pittsfield, Mass.-based firm's serum based fatty acid synthase and USP2a diagnostic assays and outlines the use of FAS as a monitoring tool. The company said it began the filing process in mid-2011.

In October Nuclea raised $6.4 million to support its FDA submission for the assays, as well as facility upgrades, new hires, and general operations.

Nuclea develops gene- and protein-based diagnostic tests for the prognosis of disease outcome and for the prediction of therapeutic response. Its three businesses are Nuclea Diagnostic Laboratories, Nuclea Biomarkers, and Nuclea Biotherapeutics. Each operate as wholly owned subsidiaries.

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