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The test is the first in a proposed line of assays that will run on the GeneXpress platform with run times of around 30 minutes.
The next-generation sequencing-based test is designed to detect bacteria and viruses in blood samples from patients with suspected infections, especially immunocompromised patients.
The firm said that molecular product sales were up 103 percent, driven by the launch of the Solana Group A Strep assay earlier this year.
For the 40-target panel, the trial found an overall average weighted sensitivity and specificity of 90 and 99 percent, respectively.
The FDA go-ahead marks Quidel's fourth MDx test to receive 510(k) clearance for the Solana platform.
Papilloplex, a kit to detect and differentiate all 14 high-risk HPV genotypes, can be used on cervical swabs and urine samples.
Synlab, a European lab services provider, found the test performed well on samples with low bacterial load and non-respiratory samples.
The $4 billion acquisition is now cleared in the US, Germany, Austria, and South Africa.
The firm also reported a 46 percent increase in molecular biology sales due to growth in its FilmArray line.
The Chinese firm is also developing a menu of extraction-free molecular diagnostic tests using a proprietary "one-step" reagent.
The company said it expects a 1 percent increase in 2016 revenues, but noted that the results were adversely affected by certain competitive pressures in Q4, among other problems.
The assay uses loop-mediated isothermal amplification to directly detect Streptococcus agalactiae infection, a common cause of neonatal meningitis.
The updates include the addition of urine as a specimen type and commercially-sourced inactivated virus as a positive control.
The test detects 11 viruses and three bacterial pathogens in approximately one hour and requires two minutes of hands-on time.
The portable system uses centrifugal microfluidics, with molecular tests deploying a visualization method that obviates the need for sample prep.
The research aims to validate new predictive tests that would enable development of diagnostic and therapeutic solutions to fight sepsis.
The real-time PCR-based test runs on the BD Max system and comes in a single tube that snaps into the BD MAX extraction cartridge.
Researchers implemented qPCR on TaqMan Array Cards to find six pathogens are responsible for up to 90 percent of childhood diarrhea at seven sites in Africa and Asia.
Under the contract, DNAe will develop tests for antimicrobial resistant infections and influenza that it submits to the FDA for clearance.
The test runs on the company's Solana instrument, which can process up to 12 patient samples in a 45-minute run.