Trending...
- RAS AP Consulting Expands Managed AP Governance™ Ecosystem, Launches Trademark Process, and Secures IFOL Speaker Invitation
- UK Financial Ltd Makes History: Chainlink CRE Circulating Supply Verification Goes Live Across Its Complete Ecosystem Of Nine Exchange-Traded Tokens
- FDA Clears Major Regulatory Hurdle as Preservative-Free Ketamine Program Moves Within Reach of Commercialization: NRx Pharmaceuticals: (NAS DAQ: NRXP)
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:
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.
More on ncarol.com
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."
More on ncarol.com
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. 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.
"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.
More on ncarol.com
- Move in this Fall! New Released Quick Move-In Townhomes at Heritage at South Brunswick with Limited-Time Incentives
- Crossroads4Hope Marks 25 Years Ensuring No One Faces Cancer Alone At its Inspiring Hope Gala
- Q1 2026 Arizona Technology Industry Impact Report Recaps Advanced Manufacturing Growth, High-Value Jobs and Workforce Investment
- Former Prosecutor Opens Stegall Law in Summerville
- Vboost Celebrates 14 years of Automotive Viral Marketing
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."
More on ncarol.com
- EXETR Exteriors Unveils XOS — Proprietary Roofing Project Management Platform
- Ignazio Arces Wins Stevie® Award for Maverick of the Year at the 2026 International Business Awards
- New from Regal House, The Great Awakening: dark comic vision of a split nation veering off the rails
- Tickeron Highlights AI Trading Agent Performance Across Multiple Market Sectors
- Stop Bleeding Cash on Mediocre Talent. Build a Powerhouse Remote Team Instead
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. 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.
Filed Under: Business
0 Comments
Latest on ncarol.com
- PricZone Launches Online Shopping Platform Offering Electronics, Gaming, and More
- Heritage at South Brunswick Introduces New Ferndale Floorplan: The Largest Single-Family Home Design in the Community
- Lineus Medical Elevates Leadership to Accelerate Growth After Breakthrough Clinical Results
- Gateway Center Arena Announces Duane Curry as General Manger
- New from Regal House Publishing, The Parliament of Mice, classic animal fables retold as satires
- XRPPower Expands Platform Security With Enhanced Brand Protection and Official Verification Standards
- Cuvo Health, the #1 White Label Telehealth Platform, Surpasses 300 Exclusive Providers Serving All 50 States
- RAS AP Consulting Expands Managed AP Governance™ Ecosystem, Launches Trademark Process, and Secures IFOL Speaker Invitation
- UK Financial Ltd Makes History: Chainlink CRE Circulating Supply Verification Goes Live Across Its Complete Ecosystem Of Nine Exchange-Traded Tokens
- International Rights Groups Raise Alarm Over Freedom of Religion and Expression in South Korea
- The City's Most Elegant Open-Air Dinner Party Returns September 12, 2026
- FDA Clears Major Regulatory Hurdle as Preservative-Free Ketamine Program Moves Within Reach of Commercialization: NRx Pharmaceuticals: (NAS DAQ: NRXP)
- Autonomous Robotics Platform Expansion as Public Market Debut is Very Close: MBody AI Corp. (N A S D A Q: MBAI)
- New Book gives Consumer Goods Leaders a Governance Playbook for Generative and Agentic AI
- Loud! OOH calls for prize draw advertising standards as £1.3bn category moves outdoors
- Black Ribbon Productions Launches With Fearless 2026 Horror Slate
- Actor Dominic Pace Returns to Television and Film
- Opteamix welcomes Girish Ramachandra to its leadership team as Senior Vice President of Client Services
- Silicon Box Ships 500M Units at High Yield, Expands Production Capacity for Panel-Level Packaging
- Why Baton Rouge's Humid Climate Can Contribute to Carpenter Ant Damage — J&J Exterminating Explains How to Protect Your Home