Industry executives said that clinical needs associated with antimicrobial resistance and sepsis are generating more interest in AST technologies.
The firm said that its new hematology-based cellular biomarker test has the potential to advance clinicians’ approach to sepsis triage and diagnosis.
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.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
The funds will be used to support development and early marketing of a rapid test system for antibiotic resistance targeting patients with suspected sepsis.
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 firm expects to use the funding to meet demand for its Steripath platform, which improves accuracy, consistency, and predictability of diagnostic lab tests.
The new regulatory approvals add to previous approvals in Singapore, expanding the firm's reach in the Association of Southeast Asian Nations region.