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Tag Archives: Nuclea Biotechnologies—

RUO biomarker tests, 9/15

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.

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Nuclea, CRL to offer diagnostic assays, 8/14

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.

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HER2/neu blood test, 1/14

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).

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