Genes2Me announced on Thursday that its OnePCR system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This approval paves the way for the company to market and deploy its integrated qPCR platform across clinical laboratories, hospitals, and point-of-care settings in the United States.
The OnePCR system integrates cartridge-based technology with automated nucleic acid extraction, rapid amplification, and real-time detection, offering a streamlined solution for molecular diagnostics. Genes2Me has developed a comprehensive test menu of over 50 CE-marked assays tailored for this platform.
According to the company’s website, OnePCR delivers results in 30 to 70 minutes, supports multiplexing of up to 20 targets, and features a five-channel fluorescence system along with a circular cassette design for ease of use and scalability.
As part of its global expansion strategy, Genes2Me appointed industry veteran John Bishop to its advisory board in May, aiming to strengthen its product roadmap and drive growth in international markets.