NEW YORK (GenomeWeb) – Startup PapGene announced today that it has received Breakthrough Device designation from the US Food and Drug Administration for its blood-based cancer diagnostic assay.

The FDA granted the status based on the assay's ability to detect both ovarian and pancreatic cancer. PapGene's assay uses a combination of circulating tumor DNA and protein biomarkers to detect cancers in average-risk, asymptomatic individuals over the age of 65.

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In Science this week: International Wheat Genome Sequencing Consortium publishes the bread wheat cultivar Chinese Spring reference genome, and more.

At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.

The New York Times reports that genetic testing has uncovered unfaithful penguins at a Utah aquarium.

Cancer researcher loses funding under new Wellcome Trust anti-bullying policies, the Guardian reports.

Aug
27
Sponsored by
Qiagen

This webinar offers a look at how an advanced genetics laboratory implemented and validated a commercial bioinformatics system to help scale its operations.

Sep
17
Sponsored by
SeraCare

Today’s challenging clinical next-generation sequencing applications require a rigorous, comprehensive quality control management program to ensure confidence in results.

Sep
18
Sponsored by
Horizon Discovery

In this webinar, Kevin Balbi, head of bioinformatics at Sarah Cannon Molecular Diagnostics, will discuss the validation of targeted sequencing panels on the Ion Torrent platform using Horizon Discovery’s Tru-Q controls.