DIAGNOSTICS | FDA Clears Baebies Disposable Enzyme Deficiency G6PD Test

Baebies, a US developer of screening and pediatric testing technology, has received Food and Drug Administration (FDA) 510(k) clearance for its rapid, point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. The test is run on the FINDER® platform, which features a toaster-sized instrument and a disposable cartridge.


Using a 50 µL blood sample (one drop of blood), FINDER delivers results approximately 15 minutes after sample introduction. Test results display G6PD enzyme activity in units per gram of hemoglobin and adjusted male median values. The company announced completion of CE Mark for FINDER in December 2019.

The FINDER platform is powered by digital microfluidics (DMF) technology – a method to programmably manipulate tiny droplets of liquid by electrical control of surface tension on a disposable cartridge. DMF technology eliminates the need for mechanical pumps or valves for liquid handling, reducing the required sample volume and providing fast and reliable diagnostic results.

‘’This is a significant milestone not only for our company but for patients whose lives can be improved by detection of G6PD deficiency’’ said Richard West, CEO of Baebies. ‘’FINDER performs rapid testing from just one drop of blood, making testing easier and more accessible. With G6PD as the first FDA-cleared test on our FINDER platform, we look forward to adding many additional types of tests to the versatile and multifunctional platform’’

G6PD deficiency is the most common enzyme deficiency worldwide, affecting approximately 400 million people. A defect in the G6PD enzyme causes premature destruction of red blood cells, which are a key component of the oxygen carrying system.

‘’Early diagnosis of G6PD deficiency is critical to ensure children and adults living with G6PD deficiency receive the care they need to manage symptoms and prevent complications later on in life’’ said Vamsee Pamula, PhD, President of Baebies.

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