Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.