The partners inked a licensing deal to market and distribute TGen's DeepChek-TB as a compact, portable, and affordable diagnostic model for physician use.
The test can detect resistance to two of the most commonly prescribed antibiotics used to treat strep throat, and could potentially be adapted for point-of-care use.
Along with WHO, Mologic, and Leiden University Medical Center, FIND is developing two rapid diagnostic tests to detect circulating anodic antigen in blood or urine.
Regional Medical Laboratory, a commercial reference lab, is using the Alinity next-gen immunoassay system in the face of growing test volumes and a shortage of trained labor.
The test will leverage next-generation sequencing to sequence PCR amplicons of the UL54 and UL97 genes in which drug resistance with CMV has been associated.
Revenues included sales to the former US lab business and revenue from T-SPOT.TB tests sold to Quest after Nov. 6 as part of a long-term supply agreement.
The firm said it secured a record 14 new contracts of T2Dx instruments in the fourth quarter, which was at the high end of its guidance for the second half of 2018.
The test is designed to identify and differentiate between Zika, dengue, and chikungunya in serum samples, even in the presence of more than one target.
BioMérieux received clearance for its Vitek 2 gram-negative susceptibility card as a test used to determine the antimicrobial susceptibility of certain aerobic bacilli.
In an SEC document, the company said net proceeds are expected to be $5.8 million and will be used to support an anticipated submission to the FDA, among other things.
Since moving to rapid molecular testing, the lab has doubled its billable test volume, largely through increasing clients for its outreach lab services.
