US-based medical device and diagnostics firm Baebies has secured CE Mark for its Finder SARS-CoV-2 point-of-care test to detect SARS-CoV-2, the virus that causes Covid-19.

The CE Mark will enable the firm to commercialise its Finder SARS-CoV-2 test, which performs RT-PCR testing to detect SARS-CoV-2 on the Finder 1.5 instrument, across the European Union and other CE Mark geographies.

Equipped with Baebies’ core digital microfluidics (DMF) technology, the platform streamlines the traditional RT-PCR testing process, enabling lab-quality results to be delivered directly at the point of care.

The test detects RNA from the virus in nasopharyngeal and nasal swab specimens in 17 minutes or less. The findings of traditional RT-PCR testing are usually available after 24 hours.

The Finder platform uses a single-use disposable cartridge to run the test with the help of compact, toaster-size equipment with a mini tablet for user interface, said the company.

Baebies co‑founder and CEO Richard West said: “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.

“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.”

Baebies said the Finder 1.5 Instrument can empower labs, hospitals and other point-of-care settings to fulfil the need for fast and accurate testing with a speed of rapid antigen test and the accuracy of an RT-PCR lab test.

The firm is developing additional panels utilising the same cartridge format and instrument in case of any for future expansion.

In February 2017, Baebies received FDA clearance to market its newborn screening system to detect four lysosomal storage disorders (LSDs).