Tag Archives: Nuclea Biotechnologies

November 2015—Nuclea Biotechnologies has met the requirements from the FDA for its Carbonic Anhydrase IX Automated immunohistochemistry kit as a class I in vitro diagnostic device for use on a Ventana Benchmark XT instrument.

Nuclea Biotechnologies will begin offering more than 50 research-use-only mass spectrometry–based biomarker tests as part of its laboratory services. The tests detect and quantify protein biomarkers in human serum or plasma and are available to pharmaceutical companies for clinical trials, to researchers, and as companion diagnostics.

April 2015—Nuclea Biotechnologies is partnering with St. Louis-based BacterioScan to validate the BacterioScan 216Dx instrument in a CLIA-certified laboratory. This collaboration will focus on antimicrobial susceptibility testing to guide the best course of antibiotic treatment for different strains of urinary tract infections.

August 2014—Nuclea Biotechnologies has partnered with Clinical Reference Laboratory for initial CLIA assay validation and subsequent laboratory processing in support of three of Nuclea’s key tests. Initial efforts will focus on Nuclea’s flagship assay, the Oncogene Science 159 gene-based prostate cancer monitoring test, and its Nuvera breast cancer assay.

April 2014—Nuclea signed development deals with AccuGenomics and Nuvera Biosciences that will include validating two new assays in the treatment of chronic myeloid leukemia and breast cancer.

January 2014—With the recent acquisition by Nuclea Biotechnologies of Wilex (Oncogene Science), Nuclea will begin its foray into the GMP manufacturing and marketing of the FDA 510(k)-cleared HER2/neu blood test out of its facility in Cambridge, Mass. The test is available as an in vitro diagnostic in the U.S., Canada, and Europe (CE mark).