NEW YORK (GenomeWeb) – T2 Biosystems today said that it has filed a 510(k) premarket submission with the US Food and Drug Administration for its T2Dx system and T2Candida assay.

The Lexington, Mass.-based firm said that it has submitted clinical trial data to the agency providing evidence that the instrument and assay can identify specific life-threatening, sepsis-causing pathogens directly from an unpurified blood sample in as fast as three hours. Current culture-based diagnostic methods typically take two to five days to provide an answer, T2 noted.

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: co-evolutionary signatures of insect hosts and bacterial symbionts, distinct transcript isoforms of high-grade ovarian cancer, and more.

Adam Rutherford discusses genetic genealogy at the Guardian.

Portions of the US 21st Century Cures Act are raising some safety concerns.

David Dobbs writes at Buzzfeed that genomics has delivered little on its promises.