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The test, built on the company's VeraCode technology, is for Factor V and Factor II.

An FDA official said that the agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

FDA believes Pathway Genomics is offering a device that has not been cleared for marketing by the agency, and that the firm has "moved outside of the currently sanctioned boundaries for lab-developed tests by marketing a product in a retail store that asks consumers to collect the sample."

The FDA said that in expanding its DTC genomics service from the internet to Walgreens, Pathway Genomics "has moved outside of the currently sanctioned boundaries for laboratory-developed tests."

An FDA advisory committee acknowledged that next-generation sequencing is a powerful tool for ensuring vaccines are free of harmful contaminants, while expressing concerns about data interpretation as well as the challenges of implementing a regulatory framework for sequencing-based vaccine QC.

At the European Lung Cancer Conference last week in Geneva, Biodesix presented data from a multi-center Phase III study that showed VeriStrat was able to identify NSCLC patients most likely to have a "significant survival benefit" from treatment with Tarceva.

Strand's software "will be advantageous to both the FDA and the industry to manage pharmacogenomic data submissions," FDA's Frederico Goodsaid said.

CEO Jay Flatley called the clearance of BeadXpress for use in in vitro diagnostics a "significant and exciting transitional step" for the company into the diagnostics market.

After pharmacogenetic analysis in a Phase II melanoma study for tremelimumab failed to yield any clinically meaningful gene-response markers, Pfizer inked a codevelopment deal with Debiopharm handing over Phase III development of the drug with a protein marker linked to response. But commercialization rights still belong to Pfizer.

“These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts,” Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.

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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.