The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
This test is the firm's second assay on the point-of-care Accula molecular diagnostics system.
The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.
The Dublin-based company also aims to raise up to €5 million this year to support additions to its R&D and sales and marketing teams.
The firms intend to seek CE marking and US Food and Drug Administration clearance for the test.
The company's microchip-based technology will detect viral and bacterial genetic material using both isothermal amplification and electrochemical measurements.
The test detects and differentiates respiratory syncytial virus and human metapneumovirus on the firm's Solana rapid molecular platform.
The assay runs on the Panther Fusion system, which combines transcription-mediated amplification, real-time TMA, and real-time PCR with full sample-to-result automation.
The panel, developed by collaborator Janssen, is expected to improve detection of influenza and respiratory syncytial virus.
The assay was cleared and CLIA-waived for use on Quidel's Sofia 2 instrument for the detection of RSV using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens.