Trending...
- Cut Costs & Boost Profits with the First Major Upgrade in 30 YEARS Replacing Rotary Lasers and Historic Clear Tube Altimeter Bubbles
- BumblebeeSmart Introduces Rounded Busy Board Set for Preschoolers
- 38 States Complete. 12 States Remain. California Man enters North Carolina on Historic Quest to Cross All 50 States on Foot
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
- Little Wheels Adds Parent Recording to Vehicle Tales, Turning Bedtime Stories into Family Keepsakes
- Rio Bela Cosmetics Launches Inclusive Line of Organic Skincare Products
- The 7 Visibility Problems Costing Independent Hotels Thousands Every Month
- Jackson Hewitt New Management Event
- Viola's Babygirl's, LLC Proudly Announces Teri Tobin's Soulful New Christmas EP "Home For The Holidays"
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
- Stoxtel Introduces High-Throughput "Matrix" Engine to Address Mexico's Crypto Trading Volatility
- UK Financial Ltd Sets Listing Date With Catex Exchange For The Listing Of Mayacat The World's First Ever Gold Backed ERC 3643 "SEC Ready" Token
- Cyntexa Announces Updates to ChargeOn on Salesforce AppExchange
- Althea Gibson Honored as Final Release in U.S. Mint's American Women Quarters Program
- Lokal Media House Achieves Yelp Platinum Partner Status
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
- Revenue Optics Announces the Appointment of Sonal Chowdhury as Senior Manager – Strategic Operations
- How California Convinces Buyers Not to Purchase New Cars — and How This Hurts Dealers
- Tax Fears and Political Volatility Drive Wealthy UK Residents to Consider Leaving, La Vida Survey Shows
- Titan Steel Buildings Expands Nationwide to Deliver Large Steel Warehouses and Industrial Facilities
- Marry Me Marinara Announces New Gourmet Pasta Sauce - Bringing Restaurant Quality to Home Kitchens
- Kaltra Removes Size Barriers for Microchannel Coils with Fully Integrated Large-MCHE Production
- Guests Can Save 10 Percent Off New Vacation Rental Homes at KeysCaribbean's Village at Hawks Cay Villas
- Paylode Acquired by Moved to Power the Next Generation of Ancillary Revenue Automation
- Global Preschool Giants Unite to Celebrate the 12th Anniversary of Badanamu's Hit Song "Ponytail"
- America's Leading Annuity Expert Carlton Cap Averil II Joins Tom Hegna on "Financial Freedom with Tom Hegna"
- Cheeron Partners with CRCC to Support Shanghai East Railway Station
- MiBoxer Shines at 2025 Hong Kong International Lighting Fair, Intelligent Lighting Solutions Acclaimed by Global Clients
- Anern Launches the AN-SLZ2 Smart Integrated Solar Street Light
- "Nikko Kitchen," Tochigi Prefecture's New Gourmet Eatery, has Opened Near Tobu Nikko Station
- Michael Gi Delivers Inspiring New Gospel Releases That Lift Hearts and Honor Legacy
- Ashley Wineland To Release Scorching Single and Film Noir Cinematic Video for 'Love Letter'
- Why Gourmet Steaks Are the Perfect Holiday Gift
- Make This Fall Your Most Stylish Yet with Nickel-Free Bestsellers from Nickel Smart
- Platinum Plumbing Launches First Veteran Hot Water Heater Giveaway to Honor Local Heroes
- Cut Costs & Boost Profits with the First Major Upgrade in 30 YEARS Replacing Rotary Lasers and Historic Clear Tube Altimeter Bubbles