The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
The fourth test for which the firm has received regulatory clearance this year takes aim at a common microbial cause of healthcare-associated infections.
T2 said that the panel will be commercially available in Europe in Q3, and added that it is in the midst of completing a pivotal trial in preparation of a submission to the FDA.
The Sentosa SQ HIV genotyping assay is now approved in Australia and the Sentosa SQ melanoma panel is approved in Singapore.
Promega would first seek clearance for an assay that detects dMMR in colorectal cancer patients, and could seek a far broader clearance in the long term.
The firm said it will offer 25 million units consisting of common stock and common warrants at $.40 per unit.
