The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
A European study, published today in NEJM, used a POC, PCR-based system to perform CYP2C19 genotyping to guide platelet inhibitor therapy.
The test is the cornerstone of a study involving roughly a thousand patients from two British neonatal centers that is set to commence this fall.
Filter tips for use with QiaSymphony SP/AS instruments may leak, which could lead to delayed or inaccurate results and cause serious injury or death.
NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems.
The Cobas TV/MG test detects Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.
The firm said its new molecular platform, which offers random-access testing, high throughput, and a broad menu has the potential to replace multiple instruments in molecular labs.
An early user of a new Mycoplasma genitalium and antibiotic resistance test from SpeeDx that uses the Xpert cartridge shared some initial validation data.
The firm said that its cell-free DNA assay has shown a high positive predictive value in preliminary clinical studies involving stage IV colorectal cancer patients.