Baebies said on Wednesday that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a rapid point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, which causes hemolytic anemia.
The test is run on the firm's Finder platform, which consists of a toaster-sized instrument and disposable cartridge. Using one drop of blood, Finder provides results in approximately 15 minutes after the sample has been introduced to the instrument, Baebies said.
Test results display G6PD enzyme activity in units per gram of hemoglobin and adjusted male median values.
The G6PD test is the first to be cleared by the FDA to run on the Finder platform.
The most common enzyme deficiency, G6PD deficiency affects 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.
The most common clinical symptom associated with G6PD deficiency is hemolytic anemia, which occurs when red blood cells are destroyed faster than the body can replace them. This type of anemia leads to paleness, jaundice, dark urine, fatigue, shortness of breath, and a rapid heart rate.
In addition to causing hemolytic anemia, G6PD deficiency is also a significant cause of mild to severe jaundice in newborns and in some cases, can lead to kernicterus.
Baebies noted that early diagnosis is critical to ensure that children and adults living with G6PD deficiency receive the care they need to manage symptoms and prevent complications later in life.
The Durham, NC-based digital microfluidic company announced completion of the CE Mark for Finder in December 2019.