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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Researchers have sequenced the northern white rhinoceros to gauge whether it could be brought back from the edge of extinction, the New York Times reports.

Bavaria expands its forensic genetic analyses to include DNA phenotyping, raising discrimination concerns.

Tufts University researchers found a role for miRNA in transmitting stress between generations, the Economist reports.

In Science this week: gut microbiome influences liver cancer growth, spread; and more.

Jun
14
Sponsored by
Sophia Genetics

This webinar will discuss an effort underway at the University of North Carolina Medical Center's to overcome limitations in the hematological genomic testing workflow with artificial intelligence (AI) from Sophia Genetics.

Jun
19
Sponsored by
Advanced Cell Diagnostics

This webinar will provide evidence for the use of RNA in situ hybridization (RNA ISH) as a replacement for immunohistochemistry (IHC) in cancer research and diagnostic applications.

Jun
20
Sponsored by
PerkinElmer

In this webinar, Michael Quail of the R&D Sequencing team at the Wellcome Trust Sanger Institute will provide an expert perspective on library prep for next-generation sequencing.

Jun
28
Sponsored by
PerkinElmer

This webinar will review a standardized, high-throughput, and fully automated library prep protocol for human metagenomic analysis.