Baebies has obtained 510(k) clearance for its point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency from the US Food and Drug Administration (FDA).
The new test runs on the company’s Finder platform, which consists of a toaster-sized instrument and disposable cartridge.
Powered by digital microfluidics (DMF) technology, the Finder platform uses only one drop (50µL) from a blood sample and delivers results in about 15 minutes.
The G6PD testing platform displays the G6PD enzyme activity results in units per gram of haemoglobin as well as the adjusted male median values.
In December 2019, the company secured CE mark for the Finder platform.
Baebies co-founder and CEO Richard West said: “This is a significant milestone not only for our company but for patients whose lives can be improved by detection of G6PD deficiency.
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“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.”
According to the company, deficiency in G6PD enzyme causes premature destruction of red blood cells.
Haemolytic anaemia is the most common clinical symptom associated with G6PD deficiency.
G6PD deficiency also causes mild to severe jaundice in newborns and can lead to kernicterus in some cases.
Baebies co-founder and president Vamsee Pamula said: “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.”
The company stated that many other assays are currently under development on its Finder platform, with a focus on addressing the unmet needs in haematology and infectious disease through multifunctional syndromic testing.