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Prodesse's assay will follow BD's moelcular diagnostic assay, which received FDA OK earlier this year.

The planned phase I study is expected to enroll around 30 patients with elevated low-density lipoprotein, and will examine the effects of a single administration of the drug on levels of the cholesterol.

The issue is divisive in that results from a comparative effectiveness study could alter how insurers reimburse certain drugs and diagnostics, which could in turn change physicians' prescribing habits.

The assay, based on the Oncotype DX platform, met the primary endpoint for determining the likelihood of post-operative disease recurrence in patients with stage II colon cancer, but did not meet the endpoint for the ability to predict benefit from post-operative 5-fluorouracil/leucovorin treatment.

The new assay is the fourth real-time test submitted by Prodesse for FDA clearance.

Citing the FDA's handling of KRAS testing for anti-EGFR monoclonal antibodies, the report asserts that in the near term complex genetic tests such as Oncotype DX should be "performed through CLIA labs, and not held up by slow regulatory processes."

Short Reads: Apr 7, 2009

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Genome Analysis Centre, University of Barcelona, NIAID, Massachusetts Institute of Technology, J. Craig Venter Institute, University of Maryland, SeqWright, Hologic, BioReference Laboratories, GeneDx, University of Michigan, Genomatix Software, NHGRI

Quest, whose ClariSure test is based on a bacterial artificial chromosome array, is also considering adopting oligonucleotide array-based platforms sold by companies such as Affymetrix, Agilent Technologies, Illumina, and others.

Osmetech is betting the five-year deal will expand its sales and marketing efforts in the US and allow it to allocate more resources towards bringing its pipeline of tests to market.

James Czaban, Frank Barone

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President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.

A study of Great Danes homes in on a genomic region linked to fearfulness.

CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.

In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.