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The Center will use the funds to study labeling of genetic tests, direct-to-consumer genomic test marketing, and genetic discrimination.

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.

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The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.