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FDA Warns Exact Sciences that CRC Assay Requires Premarket Approval
 
Exact Sciences said this week that it has received a warning letter from the US Food and Drug Administration notifying the company that its colorectal cancer screening assay will require premarket approval.
 
In the letter, the FDA's Office of In Vitro Diagnostics Device Evaluation and Safety said it believes the company’s DNA-based PreGen-Plus assay is a medical device and therefore requires premarket approval or clearance.

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The World Bank is seeking approval for a $12 billion plan to provide low-income nations with funds to procure SARS-CoV-2 vaccines, according to Reuters.

The Washington Post reports that Herbert Tabor, who worked at the US National Institutes of Health for 77 years, has died at 101.

Science writes that public health officials and others are debating whether cycle threshold values should be included on SARS-CoV-2 results.

In Nucleic Acids Research this week: online database of SARS-CoV-2 protein structures, atlas of the human brain, and more.

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This webinar will discuss a new method that relies on Crystal digital PCR from Stilla Technologies to monitor chimerism in patients after stem cell transplantation, which is a key part of surveillance for impending clinical relapse.

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This webinar will share the Lorraine Cancer Institute's experience in implementing a novel targeted solution to accurately assess homologous recombination repair (HRR) deficiency by analyzing a series of genes, beyond BRCA, and calling multiple types of variants, including copy number variants (CNVs).

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