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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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Politico reports that the NYPD DNA database has grown since it announced it would be removing profiles from it.

Forbes reports that a structural biology lab at Oxford University studying the coronavirus was hacked.

Science reports that a Dutch research funding agency is combating a ransomware attack.

In Science this week: set of 64 haplotype assemblies from 32 individuals, and more.

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Fabric Genomics

The growth of next-generation sequencing (NGS) testing presents both opportunities and challenges for clinical, informatics, and laboratory teams. 

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Wastewater based epidemiology (WBE) has been established as a viable, valuable, and cost-effective means to monitor infectious disease within a community. 

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This webinar will outline the development and commercialization journey of a novel CRISPR-based SARS-CoV-2 test.