The test completes a suite of assays designed to detect pathogens that can cause sepsis using the firm's ePlex system.
Immunexpress received US clearance for a direct-from-blood sepsis test in 2017 and recently won a contract to commercialize a sample-to-answer sepsis assay.
The projects, set to begin this year, concern prostate cancer, infectious diseases, rheumatoid arthritis, inflammatory bowel disease, heart disease, and sleep disorders.
While the study showed initial promise, further work will be necessary to clarify its performance for various clinical indications.
The RT-qPCR-based assay, which has 510(k) clearance, is designed to rapidly differentiate sepsis from systemic inflammatory response syndrome.
The new regulatory approvals add to previous approvals in Singapore, expanding the firm's reach in the Association of Southeast Asian Nations region.
The research highlighted particular challenges for gram-negative organisms among a population of higher-risk patients.
The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.
The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.
With a DNA methylation atlas and deconvolution algorithm, researchers are attempting to trace cfDNA back to tissue sources in healthy or ill individuals.
The New York Times Magazine examines gender discrimination at the Salk Institute.
Science reports that MD Anderson Cancer Center has dismissed three researchers over foreign tie concerns.
A second death in gene therapy trial for type 1 spinal muscular atrophy is under investigation, according to Reuters.
In PLOS this week: antibiotic resistance patterns in Escherichia coli, a dozen genetic loci tied to varicose vein risk, and more.