DURHAM, N.C. – (March 24, 2022) – Baebies® announced today it has received CE Mark for its FINDER® SARS-CoV-2 point-of-care test, which performs RT-PCR testing to detect SARS-CoV-2 on the FINDER 1.5 Instrument. The CE Mark confirms that the FINDER SARS-CoV-2 test meets the requirements of the European Medical Devices Directive, which now allows Baebies to commercialize the test across the European Union and other CE Mark geographies.
The FINDER SARS-CoV-2 testing platform leverages Baebies’ core digital microfluidics (DMF) technology to streamline and miniaturize the conventional RT-PCR process, enabling lab-quality results directly at the point of care. The test provides qualitative detection of RNA from the SARS-CoV-2 virus in nasopharyngeal and nasal swab specimens with RT-PCR performed in 17 minutes or less. Conventional RT-PCR testing results are typically reported after 24 hours. The testing platform features a compact, toaster-sized instrument with a mini tablet for user interface and each test is run on a single-use disposable cartridge.
“CE Mark is an important regulatory milestone for Baebies to expand the reach of our FINDER SARS-CoV-2 test and introduce the power of digital microfluidics to new markets across the world,” said Richard West, Co‑Founder and Chief Executive Officer of Baebies. “Our technology unlocks access to rapid, accurate testing at the point of care so communities can manage the threat of COVID-19 now and into the future.”
As COVID-19 restrictions lift, testing remains essential to reduce the spread of the virus. The FINDER 1.5 Instrument helps laboratories, hospitals, and other point-of-care settings meet the demand for fast and accurate testing today, delivering the speed of a rapid antigen test and the accuracy of an RT-PCR lab test. It also provides flexibility for future expansion with additional panels currently under development using the same cartridge format and instrument.
For more information about FINDER 1.5, please contact us.