Baebies Announces Submission of 510(k) to U.S. FDA for Glucose-6-Phosphate Dehydrogenase on FINDER

DURHAM, NC / ACCESSWIRE /  May 7, 2020 / Baebies, a growth-stage company developing diagnostic products to provide a healthy start for children everywhere, announced today the submission of FINDER G6PD to the U.S. Food and Drug Administration (FDA). FINDER™, a near-patient testing platform, includes a toaster-sized instrument and a disposable cartridge, which tests for Glucose-6-Phosphate Dehydrogenase (G6PD) from low blood volume (50 µL) with a turn-around time of approximately 15 minutes after sample introduction.

G6PD deficiency is the most common enzyme deficiency worldwide, affecting approximately 400 million people. Hemolytic anemia is the most common clinical symptom associated with G6PD deficiency that is most often triggered by bacterial or viral infections, antibiotics and drugs including those that are used to treat malaria, and foods such as fava beans. Hemolytic anemia can lead to jaundice, shortness of breath, and rapid heart rate.

Richard West, Co-Founder and Chief Executive Officer of Baebies commented, "With the submission of FINDER G6PD to the FDA, Baebies takes an important step forward in support of our mission. This is the first of many tests to come on the FINDER platform, which will fully exploit the flexibility of digital microfluidic technology. We look forward to continued communication with the agency through the review process."

FINDER received CE Mark in December 2019 as an In Vitro Diagnostic device (IVD) and is commercially available in Europe and other countries that recognize CE Mark. FINDER is not currently for sale in the United States.

About Baebies

Baebies – guided by the vision that "everyone deserves a healthy start" – develops and commercializes products and services that enable early disease detection and comprehensive diagnosis for children. Baebies' products include SEEKER®, an FDA-cleared and CE-marked high throughput newborn screening platform, and FINDER™, a CE-marked low volume pediatric testing platform that is currently not commercially available in the U.S. Our mission is to save lives and make lives better for all children by bringing new technologies, new tests and new hope to parents and healthcare professionals worldwide. To further our mission, Baebies also provides expanded newborn screening services from its CLIA-certified laboratory. Baebies is headquartered in Durham, North Carolina. For more information visit baebies.com and follow us on LinkedIn, Twitter and YouTube.

CONTACT:

Emily McLoughlin
emcloughlin @ baebies.com

SOURCE: Baebies, Inc.

ReleaseID: 588745