Credo Preps MDx System, Multiplex Respiratory Test for US Launch
NEW YORK – Singapore-based Credo Diagnostics Biomedical is preparing to start US clinical trials for a new near-patient point-of-care molecular diagnostic system and multiplex respiratory test. The company intends to submit the instrument and assay to the US Food and Drug Administration for 510(k) clearance and to use it as a springboard for entering the US diagnostic testing market. Called the VitaSIRO solo™— with SIRO short for “sample-in, results-out” — the new system was developed with the intention of bringing lab-quality testing to the point of care, according to Tan Tai Lim, the firm’s vice president.
