Durham’s Baebies Gains FDA Approval for Diagnostic Test

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Baebies, a medical device and diagnostics company in Durham, has received permission from the U.S. Food and Drug Administration to market a rapid, point-of-care test for the world’s most common enzyme deficiency.

The permission, known as a 510(k) clearance, is for a test to diagnose glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic disorder that affects about 400 million people worldwide, mostly males.

“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, co-founder and chief executive officer of Baebies.

The test is run on the company’s FINDER platform and features a toaster-sized instrument and a disposable cartridge. Using one drop of blood, FINDER delivers results in about 15 minutes.

“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,” West said.

Additional assays under development are focused on addressing unmet needs in hematology and infectious disease through multifunctional syndromic testing, a seamless combination of multiple types of tests – molecular, chemistry, hematology, immunology, etc. – performed on a single platform to resolve the signs and symptoms associated with a clinical condition.

Leveraging digital microfluidics

Babies' FINDER diagnostic device
Babies' FINDER diagnostic device. -- Baebies photo

The FINDER platform is based on digital microfluidics (DMF) technology, a way to 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.

The FINDER platform and its underlying digital microfluidics technology have been recognized through multiple awards, including the Disruptive Technology Award from the American Association for Clinical Chemistry, recognizing innovative testing solutions that will transform patient care.

“Our research with Baebies has shown that the FINDER digital microfluidics platform provides rapid G6PD results using a small amount of blood,” said Beverly Rogers, M.D., chief of pathology at Children’s Healthcare of Atlanta and adjunct professor of pathology and pediatrics at Emory University School of Medicine. “Identifying G6PD-deficient patients provides potentially critical information to providers, and ensures this condition is considered when clinical care decisions are made.”

Deficiency destroys red blood cells

G6PD deficiency is caused by a defect in the G6PD enzyme, leading to premature destruction of red blood cells, a key component of the body’s oxygen-carrying system. The most common clinical symptom of G6PD deficiency is hemolytic anemia, leading to paleness, dark urine, fatigue, shortness of breath and a rapid heart rate.

G6PD deficiency is also a significant cause of mild to severe jaundice in newborns and in some cases can lead to kernicterus, a type of brain damage.

“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, Ph.D., co-founder and president of Baebies. “I am proud of our team for pioneering yet another test, and this time for point-of-care use, so clinicians can identify patients with G6PD deficiency and intervene with support so they can stay healthy.”

Vinod K. Bhutani, M.D., FAAP, professor emeritus of pediatrics at Stanford University School of Medicine, and his team of researchers were the first to evaluate the FINDER G6PD assay, assessing device performance and comparing the test to known reference methods. Results of the evaluation were published in Seminars in Perinatology, a peer-reviewed medical journal, in 2020.

“Implementation of this mode of assay in nurseries will allow clinicians to know G6PD enzyme activity before a newborn is discharged from the hospital,” Bhutani said.

Supported by NCBiotech

Baebies is a growth-stage company developing products to enable early detection of diseases and syndromes in children and adults

Guided by the vision that “everyone deserves a healthy start," the company delivers millions of tests globally every year to central laboratories and point-of-care sites around the world.

The company received a $500,000 Strategic Growth Loan from the North Carolina Biotechnology Center in 2014, when it was founded. The support helped it raise $13 million in equity financing the following year.

Barry Teater, NCBiotech Writer
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