SEEKER achieves CE Mark approval and is now accessible in Europe and other countries that…
Baebies Announces FDA Acknowledgement of Emergency Use Notification for FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test – RT-PCR within 17 Minutes
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DURHAM, N.C.--(BUSINESS WIRE)--Baebies, a growth-stage company developing innovative products to enable early disease detection and comprehensive diagnosis, today announced that the U.S. Food & Drug Administration (FDA) acknowledged the company’s Emergency Use Notification (EUN) for an RT-PCR test to detect SARS-CoV-2 on the FINDER® 1.5 Instrument. The company’s FINDER SARS‑CoV-2 Test is intended for the qualitative detection of RNA from the SARS-CoV-2 virus in nasopharyngeal and nasal swab specimens with RT-PCR performed within 17 minutes.
“Our FINDER SARS-CoV-2 test combines the accuracy of RT-PCR testing with a rapid turn-around time, which is made possible by our innovative digital microfluidics technology,” says Richard West, Co‑Founder and Chief Executive Officer of Baebies. “We are launching the FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test to address the continued need for access to fast and accurate testing in health care facilities with high complexity laboratories. Our team has worked tirelessly for the last year to bring this to market and we are very excited to reach this important milestone.”
The FINDER 1.5 platform includes a toaster-sized instrument and disposable single-use cartridge and features:
- Small footprint at just 8 inches wide with a commercial tablet interface
- Easy and intuitive workflow
- Quick installation and no specialized training needed
- Digital microfluidic technology, which minimizes sample and reagent volumes
Development of the FINDER SARS-CoV-2 Test was supported in part by funds from the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative. The underlying digital microfluidics (DMF) technology is a method to programmably manipulate tiny droplets of liquid by electrical control of surface tension on a disposable cartridge. Baebies’ DMF technology is protected by several hundred patents.
Digital microfluidics supports multifunctional assay methods – including molecular, immunoassay, and chemistry – on the same cartridge. Currently under FDA 510(k) review, FINDER tests for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a genetic defect leading to anemia and severe jaundice. FINDER can efficiently test for G6PD deficiency from low blood volume (50 µL) with a turn-around time of approximately 15 minutes after sample introduction. Additionally, Baebies has a robust development pipeline and recently won the prestigious 2020 AACC Disruptive Technology Award for FINDER in a tight competition emerging as the next innovative testing solution that will transform patient care.
“In development of our FINDER SARS-CoV-2 Test, we focused on accelerating RT-PCR and sample processing for rapid results through several innovations – all made possible by digital microfluidics,” noted Vamsee Pamula, co-founder and President. “This technology powers both our diagnostic platform, FINDER, and FDA-authorized newborn screening platform, SEEKER. Baebies’ core focus still remains neonatal and pediatric diagnostics, however, the current COVID-19 pandemic doesn’t distinguish between children and adults – everyone is at risk.”
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. Baebies has shipped over 10 million tests. Baebies’ products include SEEKER®, an FDA-authorized and CE-marked high throughput newborn screening platform, and FINDER®, a CE-marked flexible, single sample testing platform that is currently not commercially available in the U.S. The FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test have been validated but FDA’s independent review of this validation is pending. Our mission is to save lives and make lives better for all by bringing new technologies, new tests and new hope to children, parents and healthcare professionals worldwide. Baebies is headquartered in Durham, North Carolina. For more information, visit baebies.com and follow on LinkedIn, Twitter and YouTube.