The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said.
The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.
The agency has approved the use of Exact's Cologuard test for average-risk individuals aged 45 and older.
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.
Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.
The assay is for detecting varicella-zoster virus in cerebrospinal fluid and can be used with the firm's Liaison MDx instrument.
The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.
The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.
A new study catalogues the genome and evolutionary history of the oak family, UPI reports.
Dog DNA testing is a growing market, but there's still a lot of uncertainty about the accuracy of the results, the Boston Globe says.
A University of South Florida researcher is testing bone fragments to determine if they belong to Amelia Earhart.
In Cell this week: antisense Piwi-interacting RNA responses to endogenous retroviruses, proteomic patterns in hepatocellular carcinoma, and more.