GlobalData on MSN

NG Biotech announces FDA approval for diagnostic assays

NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.
The Manila Times

FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ -- In a major step forward against Antimicrobial ...
Nasdaq

T2 Biosystems Receives FDA Breakthrough Device Designation for Candida Auris Diagnostic Test

LEXINGTON, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the ...
Technology Networks

Faster, More Accurate Testing for BV and Candida

Roche’s cobas® BV/CV PCR assay aims to address frequent misdiagnosis of bacterial vaginosis and Candida vaginitis. The duplex test detects both conditions from one swab with high specificity, enabling ...
Nasdaq

T2 Biosystems Announces Submission for FDA Breakthrough Device Designation for Candida Auris Diagnostic Test

LEXINGTON, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that ...