Trending...
- T. Jones Group's Cameron Jones Serves as Judge for the 2026 CHBA National Awards for Housing Excellence
- $29.8 Million Record Setting Q1 with Boosted Annual Guidance to $160 Million for Expanding Pre-Owned Boat Dealer: Off The Hook YS, Inc. N Y S E: OTH
- SRK Collective Media Group Launches with a Modern Approach to Media, Authority Building, and Cultural Visibility
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
- Advanced AI Capabilities Reflected by Upcoming Company Name and Stock Symbol Change for Evolving Pre-Owned Boat Dealer: Off The Hook YS: N Y S E: OTH
- AI-Driven Defense Expansion, Autonomous Systems and Israeli Aerospace Manufacturing Platform: VisionWave Holdings (N A S D A Q: VWAV)
- AI Predicts the Most Likely 2026 FIFA World Cup Winner
- The AI Production Shift: Why Game Development Is Entering Its Most Accelerated Phase
- World-First AI Humanoid Robot Debuts on Cherie Barber's Ground-breaking Australian Reno Show
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
- New Survey Reveals America's Most Feared Bridges for Cyclists — Golden Gate Tops the List
- Raymond Lavine, Extended Care Benefits Advisor and Author, to Appear on National Television Series Moving America Forward
- NaturismRE Launches Structured Nudism & Naturism Encyclopedia, Aiming to Reframe Public Understanding
- AI Is Closing the Gap Between Offshore Virtual Assistants and Onshore Staff
- CCHR Highlights Concerns Over Coercive and Failed $140 Billion Mental Health Practices at Psychiatric Convention
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.
0 Comments
Latest on ncarol.com
- Derek Advanced Tracking Systems Revolutionizes Asset Monitoring with Advanced Technology
- The AI Direction Deficit: TripleTen Study Finds Staff Get Told to Use AI — But Not Trained to Use It
- $29.8 Million Record Setting Q1 with Boosted Annual Guidance to $160 Million for Expanding Pre-Owned Boat Dealer: Off The Hook YS, Inc. N Y S E: OTH
- All About Technology Celebrates 25 Years of Bridging Detroit's Digital Divide
- iatroX surpasses 500,000 clinical queries and expands specialist exam coverage
- Inside-Out Hollywood: The Relentless Rise of Joseph Nybyk (AKA Joseph Neibich)
- Husband-and-Wife Photography Team Brings Personal Approach to Families Across the Triangle
- SRK Collective Media Group Launches with a Modern Approach to Media, Authority Building, and Cultural Visibility
- MSBG Corporation Acquires GridWatch US Telemetry Automation System
- TAYP Expands Athlete Exposure Platform Beyond Georgia With New Push Into Virginia and the 757
- KT Medical Staffing Expands Concierge Nursing and Private Duty Nursing Services in Orange County
- The Millennium Alliance Achieves Great Place To Work® Certification™ Amid Continued Growth
- The Millennium Alliance Appoints Former Adweek Executive Eric Hayden Shakun as Chief Financial Officer to Accelerate Next Phase of Growth
- T. Jones Group Named Finalist Across Multiple Categories at the 2026 Georgie Awards
- Rock & Roll Fan Granted Dream Experience Thanks to Donors and Grant A Dream™ Program
- The Simplest Small Business You're Probably Not Thinking About
- San Francisco Writer Wins Webby Award, Internet's Highest Honor, for Website Based on her Novel
- EDC Weekend Comedy Special Featuring Don Barnhart & Friends — Use Promo Code FRIEND for 50% Off
- N Y S E: OTH Off The Hook YS Is Building a Vertically Integrated Marine Empire — And Investors Are Starting to Notice
- Concierge Title Agency Merges with Independence Title, Inc. to Deliver an Expanded Concierge Closing Experience Across South Florida