Trending...
- Opteamix welcomes Girish Ramachandra to its leadership team as Senior Vice President of Client Services
- 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
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
- Crownlight Strategies® Announces Federal Trademark Registration
- New Book Calls 'Sense of Belonging' the Missing Link in Student Success
- Igbozue Connecticut USA Celebrates 2026 Summer Family Picnic
- KT Medical Staffing Addresses the Questions Families Forget to Ask Before Bringing Private Nursing Care Home
- Private Autopsies Give Arizona Families Answers After Nursing Home and Care Facility Deaths
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
- OPUS Global Data Solutions Launches Food Trader Plus, Bringing Operational Control and Deal-Level Profit Visibility to Food Brokers
- Phinge CEO DeMaio Unveils Speech to Congress: User Data Sovereignty vs Tech Surveillance Capitalism, Asserting Foundational 2021 App-Less Patents & IP
- Michael Maertens Hired as Century Fasteners Corp. – Chief Financial Officer
- Beneath the Cloudline Explores Hope After Collapse in a New YA Science-Fantasy Novel
- Built to Last: Why BSI Is Among the Nation's Fastest-Growing Companies, and One of Its Best Places to Work
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
- 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
- RPR Promotes Emily Line to Chief Strategy Officer and Janine Sieja to Chief Product Officer
- Expanding Beyond Space as New Drone Market Opportunities Accelerate Growth: Ascent Solar Technologies (N A S D A Q: ASTI)
- Lauren Merrell, Dale Sorensen Real Estate, announces price improvement for an extraordinary island retreat
- Portalz Publishes FES World First Architecture Introducing a New Cryptographic Platform
- Cellofest Brings Free Cello Concerts and Community Events to Bethany Beach August 5–16
- Blue Sky Capital Strategies, LLC awarded Leasing and Financial Services agreement with Premier Inc
- Michael M. Thomas Expands Executive Leadership Across Central India Outreach and Royal Trinity School
- Northeast Airlines and Travel, Inc. Initiates FAA Part 121 Certification for Boeing 737-800 Freighter Cargo Operations
- Walker's Realty and North Jersey Properties Introduce Extraordinary Luxury Estate for Rent in West Orange, New Jersey
- Extreme Heat Strains Home Appliances: Appliance EMT Offers "Summer Rescue" Relief