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Thermo Fisher, Proteome Sciences Form Biomarker Alliance

Thermo Fisher Scientific today said that it will collaborate with Proteome Sciences to develop quantitative proteomic workflows for biomarker discovery and validation.

DiagnoCure’s PCA3 Prostate Cancer Biomarker Submitted By Gen-Probe to the U.S. Food and Drug Administration

DiagnoCure, Inc., a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced today that its commercial partner, Gen-Probe Incorporated, has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its PROGENSA(R) PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer. DiagnoCure holds the worldwide rights to the PCA3 biomarker and, in 2003, granted an exclusive sub-license to Gen-Probe for diagnostic applications.

Consortium Develops Algorithm from Blood-Based Alzheimer’s Biomarkers

In a study appearing in the newest issue of the Archives of Neurology, members of the Texas Alzheimer’s Research Consortium reported that they have identified protein biomarkers in the blood that can be used to distinguish between individuals with and without Alzheimer’s disease.

Immunogenicity Testing Proves Invaluable

Immunogenicity is a measure of the immune response to a biotherapeutic drug. It is a very relevant issue affecting not only the use of therapeutic protein drugs such as mAbs but also peptides, enzymes, cytokines, growth factors, recombinant proteins, and other biological products.

GeneNews Expected to Debut ColonSentry in New York by Year’s End

GeneNews is expected to debut in its ColonSentry colorectal cancer screening LDT in New York State either by the end of the year or within the first three months of 2011, according to an equities analyst.

Reni Benjamin of Rodman & Renshaw on Tuesday said GeneNews’s R&D partner Enzo Biochem’s clinical lab division has finished validating the PCR-based test, and is about to submit the final data package to state regulators.