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The FDA has confirmed to DxS that its TheraScreen KRAS test is a Class III device. The company is in the process of submitting its premarket approval application to the agency.

The data presented last week at the Molecular Medicine Tri-Conference showed that the investigational test detected "dramatically different" miRNA expression patterns in the blood of cancer patients compared to those who were cancer-free.

Patent Reform Act reintroduced; FDA clears UF-developed wound care tech; GSK inks ophthalmology research pact with University College London, and more ...

Qiagen said that PreAnalytix's PAXgene system is now the only collection, stabilization, and purification method — either automated or manual — available in the US for IVD use.

In Print: Mar 3, 2009

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Microarray-Related Papers of Note, February 2009

Georgia Biotech Tort-Shield Bill, Michigan 'Cluster of Innovation,' Maryland Nanobiotechnology Grants, North Carolina Biotechnology Center, Solano Economic Development Corp., Hong Kong Stimulus Package

The integration of ADMETRx's ADME evaluation and CeeTox's toxicity screening during drug discovery and lead optimization will help pharmaceutical and biotech companies efficiently improve their drug discovery decision making capabilities, a CeeTox official told CBA News.

The agency will use the mass spec system in its ARS service to develop screens for drugs in livestock and poultry.

Mari Baker is leaving Navigenics, Andrew von Eschenbach has joined a consulting firm, Jay Flatley takes a seat on Helixis' board, and more.

The molecular diagnostics developer's full-year sales swelled 16 percent, as it plans to file for regulatory clearance for a variety of tests.

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NPR says the explosion and fire earlier this week at a Russian lab that stores dangerous pathogens revives the question of whether such samples should be kept.

According to Wired, Nebula Genomics is providing a way for people to get their genomes sequenced anonymously.

A 26-year-old woman tells Cosmopolitan about learning her APOE status at a young age.

In Science journals this week: a functional genomic screen uncovers drug combination that increases KRAS inhibitor efficacy in aggressive lung cancer, and more.