Prodesse Files for FDA OK for C. Difficile Assay | GenomeWeb

NEW YORK (GenomeWeb News) – Prodesse today said that it had filed for US Food and Drug Administration clearance of its molecular diagnostics assay for Clostridium difficle.

The Milwaukee, Wis.-based firm said that it had filed for 510(k) clearance of the ProGastro Cd Assay following clinical trials conducted at several clinical labs in the US. The assay is already being used for clinical diagnostics in Europe, and additional studies of the test are currently being conducted in the UK.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In PNAS this week: diatom genetic diversity, microfluidic droplet method for single-cell screening, and more.

Scientific publishers are looking into whether artificial intelligence can help the peer-review process, Wired reports.

Researchers are using gene editing to develop more robust livestock and crops, AFP reports.

Researchers rally near the American Association for the Advancement of Science annual meeting in Boston.