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.
The kit, which was launched today, leverages real-time RT-PCR technology to detect and quantify hepatitis C virus-specific RNA with genotypes 1 to 6.
The test, which searches for fragments of DNA 200 basepairs or longer that are characteristic of diseased mucosa, may eventually compete with diagnostics like Exact Sciences' Cologuard.
The firm said that the Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.