Great Basin Receives 510(k) Clearance for C. difficile MDx Test | GenomeWeb

NEW YORK (GenomeWeb News) – Great Basin today announced it has received 510(k) clearance from the US Food and Drug Administration for its first molecular diagnostic test for Clostridium difficile.

The test is based on a technology that uses an integrated disposable cartridge containing all necessary reagents and runs on a benchtop analyzer. The goal, the Salt Lake City-based firm said, is to deliver assays that can be performed in a CLIA-rated waived or moderately complex laboratory at a lower cost than other molecular diagnostics.

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 Science this week: Neanderthal-derived DNA linked to modern ailments, and more.

Japan needs to catch up on its gene-editing research efforts, the Japan News writes.

Hundreds of people have signed an online petition calling for zero tolerance to sexual harassment in the sciences.

Jeff Huber, former Google X senior vice president, joins Grail as its CEO.

Mar
03
Sponsored by
Agilent Technologies

This webinar will discuss the use of a hybrid capture-based FFPE DNA sequencing methodology with the potential for advancing precision oncology studies.