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Baebies Receives CE Mark for Molecular POC SARS-CoV-2 Test

NEW YORK – Molecular diagnostic firm Baebies announced on Thursday that its Finder SARS-CoV-2 point-of-care test has received CE marking.

The RT-PCR test runs on the company's compact Finder 1.5 instrument, which uses digital microfluidics technology to miniaturize the PCR process. The single-use assay qualitatively detects RNA from the virus in both nasopharyngeal and nasal swab samples, returning results in about 17 minutes, the Durham, North Carolina-based company said in a statement.

Baebies currently has other test panels under development for the Finder 1.5 platform using the same cartridge format, it added. The company previously received up to $11.6 million in funding from the global nonprofit Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator to develop the platform for sepsis testing for neonates and children. 

It has also received CE marking for two newborn screening assays and a glucose-6-phosphate dehydrogenase test.