The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness.
The main question it aims to answer are:
• the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.

开始日期2023-10-02

申办/合作机构

Baebies, Inc.

NCT04146246

/ CompletedN/A

Comparative Evaluation of the FINDERTM Instrument and FINDERTM G6PD Cartridge in Adults and Neonates

A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.

开始日期2019-11-11

申办/合作机构

Baebies, Inc.

100 项与 Baebies, Inc. 相关的临床结果

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0 项与 Baebies, Inc. 相关的专利（医药）

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项与 Baebies, Inc. 相关的文献（医药）

2023-03-01·Clinical chemistry

A Spotlight on Disruptors and Innovators

Article

作者: Sweeney, Timothy E ; Pamula, Vamsee ; Shah, Ajay ; Tadimety, Amogha ; Evans, Susan ; Patel, Khushbu ; Lee, Jong

Journal Article A Spotlight on Disruptors and Innovators Get access Khushbu Patel, Khushbu Patel Assistant Professor, Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA, United States Address correspondence to this author at: 3401 Civic Center Blvd, Room 5112A, Philadelphia PA, 19104. Fax: 215-590-4162, E-mail: patelk35@chop.edu. Search for other works by this author on: Oxford Academic Google Scholar Susan Evans, Susan Evans Founder, BioDecisions Consulting, Los Gatos, CA, United States Search for other works by this author on: Oxford Academic Google Scholar Jong Lee, Jong Lee Co-founder & CEO, Day Zero Diagnostics, Cambridge, MA, United States Search for other works by this author on: Oxford Academic Google Scholar Vamsee Pamula, Vamsee Pamula Founder & President, Baebies, Inc., Raleigh-Durham, NC, United States Search for other works by this author on: Oxford Academic Google Scholar Ajay Shah, Ajay Shah Co-Founder & CEO, Cytovale, San Francisco, CA, United States Search for other works by this author on: Oxford Academic Google Scholar Timothy E Sweeney, Timothy E Sweeney Co-Founder & CEO, Inflammatix, Burlingame, CA, United States Search for other works by this author on: Oxford Academic Google Scholar Amogha Tadimety Amogha Tadimety Co-Founder & CEO, Nanopath, Cambridge, MA, United States Search for other works by this author on: Oxford Academic Google Scholar Clinical Chemistry, Volume 69, Issue 3, March 2023, Pages 216–221, https://doi.org/10.1093/clinchem/hvad004 Published: 15 February 2023 Article history Received: 28 December 2022 Accepted: 29 December 2022 Published: 15 February 2023

2020-09-01·Molecular genetics and metabolism reports4区 · 医学

Targeted next generation sequencing for newborn screening of Menkes disease

4区 · 医学

ArticleOA

作者: Mauceli, Evan ; Sokolsky, Tanya ; Kaler, Stephen G ; Parad, Richard B ; Yi, Ling ; Bhattacharjee, Arindam

PURPOSE:

Population-based newborn screening (NBS) allows early detection and treatment of inherited disorders. For certain medically-actionable conditions, however, NBS is limited by the absence of reliable biochemical signatures amenable to detection by current platforms. We sought to assess the analytic validity of an ATP7A targeted next generation DNA sequencing assay as a potential newborn screen for one such disorder, Menkes disease.

METHODS:

Dried blood spots from control or Menkes disease subjects (n = 22) were blindly analyzed for pathogenic variants in the copper transport gene, ATP7A. The analytical method was optimized to minimize cost and provide rapid turnaround time.

RESULTS:

The algorithm correctly identified pathogenic ATP7A variants, including missense, nonsense, small insertions/deletions, and large copy number variants, in 21/22 (95.5%) of subjects, one of whom had inconclusive diagnostic sequencing previously. For one false negative that also had not been detected by commercial molecular laboratories, we identified a deep intronic variant that impaired ATP7A mRNA splicing.

CONCLUSIONS:

Our results support proof-of-concept that primary DNA-based NBS would accurately detect Menkes disease, a disorder that fulfills Wilson and Jungner screening criteria and for which biochemical NBS is unavailable. Targeted next generation sequencing for NBS would enable improved Menkes disease clinical outcomes, establish a platform for early identification of other unscreened disorders, and complement current NBS by providing immediate data for molecular confirmation of numerous biochemically screened condition.

2020-01-01·Practical laboratory medicine

Fluorimetric assay with a novel substrate for quantification of galactocerebrosidase activity in dried blood spot specimens

Article

作者: Escolar, Maria ; Pamula, Vamsee K ; Burns, Debbie S ; Nuffer, Miriam H ; Bali, Deeksha ; Eckhardt, Allen E ; Pham, Hong ; Singh, Rajendra ; Ross, Peter ; Norton, Scott M ; Graham, Carrie A ; Ullal, Anirudh J

BACKGROUND:

Decreased galactocerebrosidase (GALC) enzyme activity is causative for Krabbe disease, a lysosomal storage disorder with devastating neurodegenerative consequences. Quantitative fluorimetric assays for GALC activity in isolated blood and skin cells have been described; however, no such assay has been described using dried blood spot (DBS) specimens.

METHODS:

GALC enzyme activity was measured quantitatively using fluorescence from a novel glycosidic substrate: carboxy derived from 6-hexadecanoylamino-4-methylumbelliferone. GALC activity was demonstrated on newborn DBS specimens, known Krabbe disease patient specimens, proficiency testing and quality control samples.

RESULTS:

We present data on characterization of the novel substrate and assay, including pH optimization and enzyme kinetics using a fluorimetric profile. Single and multi-day precision analyses revealed tight analytical measurements with %CV ranging from 5.2% to 14.1%. GALC enzyme activity was linear over the range of 0.31 - 12.04 μmol/l/h with a limit of detection of 0.066 μmol/l/h. Our results with this assay show a clear discrimination between GALC activities in samples from Krabbe disease patients versus presumed normal newborn samples.

CONCLUSIONS:

A fluorimetric assay for GALC enzyme activity measurement on dried blood spot specimens is feasible. Improvements to the assay including novel substrate design, increased substrate concentration and removal of sodium chloride maximize the specificity of the assay and minimize interference from β-galactosidase.

项与 Baebies, Inc. 相关的新闻（医药）

2025-04-23

·PRNewswire

Baebies Receives FDA Breakthrough Device Designation for First Point-of-Care Heparin Monitoring Test

DURHAM, N.C., April 23, 2025 /PRNewswire/ -- Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Anti-Factor Xa test on the FINDER® platform —the first point-of-care heparin monitoring assay. Designed for patients receiving unfractionated or low molecular weight heparin, the test provides results in under 15 minutes from just 50 µL of whole blood. This designation recognizes the test's potential to bring heparin monitoring closer to the patient, enabling faster and more effective dose management in critical care settings. Continue Reading Baebies FINDER Anti-Factor Xa | Cartridge Protocol | FDA Breakthrough Device FINDER Multifunctional Testing - One Platform, Multiple Types of Tests, Delivering Rapid Results for Near-Patient Use FINDER in Action: Simple 4-Step Workflow "This designation provides priority FDA review and dedicated regulatory guidance, accelerating our efforts to bring the test to market," said Richard West, Founder and CEO of Baebies. "It positions FINDER® to expand rapidly into the multi-billion-dollar coagulation testing space." Heparin dosing requires tight control to prevent both bleeding and clotting complications. In high-risk settings such as extracorporeal membrane oxygenation (ECMO), mortality rates are often around 50%, and bleeding occurs in over a third of patients. Anti-Factor Xa tests—the preferred method for guiding therapy—are confined to central labs and often take over an hour, delaying time-sensitive dosing. "It is rewarding to see our long-standing, NIH-funded collaboration with Baebies achieve FDA breakthrough," said Dr. Sitaram Emani, Associate Professor of Surgery at Harvard Medical School. "I look forward to the test supporting timely anticoagulation decisions and advancing heparin management." Unlike existing tests, the FINDER Anti-Factor Xa Test requires no centrifugation and can be run directly at the point of care or in a central lab, delivering results in minutes. It addresses a life-threatening condition, offers significant advantages over existing methods, introduces breakthrough technology where no cleared alternatives exist, and serves the best interest of patients—meeting the FDA Breakthrough Device criteria. "We're growing beyond our pediatric roots to serve broader populations by bringing multifunctional diagnostics to patients of all ages, wherever care is delivered," said Vamsee Pamula, PhD, Founder and President of Baebies . Baebies is a diagnostics company headquartered in Research Triangle Park, North Carolina. With over 22 million tests delivered globally, Baebies is a technology leader that pioneered digital microfluidics (DMF). Its multifunctional FINDER® platform supports chemistry, immunoassay, molecular, and coagulation testing from small-volume samples. Baebies was awarded the ADLM Disruptive Technology Award. Driven by its mission—Any Test, Anywhere, Everyone™—Baebies is shaping a future where diagnostic testing is accessible everywhere, delivering better healthcare for everyone—across every age and setting. Media Contact: Baebies Communications Team [email protected] 919-328-8389 SOURCE Baebies Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

突破性疗法

2025-03-11

·SYNAPSE

Press Release : LaCAR MDx Technologies acquires Baebies, Inc.'s Newborn Screening Division in the U.S.

LaCAR MDx Technologies, a company specialized in automated solutions for newborn screening, announces the strategic acquisition of the Newborn Screening division of Baebies, Inc., a U.S. company known for its innovative neonatal diagnostic technologies. This acquisition is part of LaCAR’s strategy to expand its range of solutions and accelerate its expansion into the U.S. market. Founded in December 2013 in Liège, LaCAR MDx Technologies was created through collaboration between various actors from Belgian economic and scientific networks. With a team of 78 employees spread across four locations, the mission of LaCAR is to make diagnostics faster and more accessible. The company develops innovative solutions in two high-potential sectors: newborn screening and pharmacogenetics. One of LaCAR’s main strengths lies in the development of tests that do not require DNA extraction, simplifying and speeding up genetic analyses while ensuring reliable results. Today, the company operates in more than 50 countries and provides automated solutions to nearly 250 clients. “Our goal is to provide laboratories with increasingly effective solutions tailored to the needs of newborn screening. The acquisition of Baebies Newborn Screening division represents a major step forward, allowing us to offer a more complete range and reinforce our position on the market.” – Arnaud Allaer, CEO of LaCAR MDx Technologies. Based in the U.S., Baebies is known for its innovations in newborn screening, particularly with its SEEKER solution dedicated to detecting Lysosomal Storage Diseases (LSD). Through this acquisition, LaCAR integrates cutting-edge screening technology, extending the number of diseases screened among newborns across Europe. “We share a common vision with Baebies: to provide laboratories around the world with innovative and accessible solutions. This acquisition is an opportunity to strengthen our expertise and put it to work to provide better care for all newborns” announces Arnaud Allaer, CEO of LaCAR MDx Technologies. This acquisition aims to achieve three major objectives for LaCAR: “With this acquisition, we are taking a significant step toward becoming a key player in global newborn screening. By combining our expertise with Baebies', we offer our clients even more effective solutions tailored to high-potential niche market,” adds Arnaud Allaer, CEO of LaCAR MDx Technologies. The integration of Baebies' Newborn Screening division into LaCAR will ensure continuity of operations and optimal customer support. This expansion will have a direct impact on employment and technological development. Following this acquisition, LaCAR plans to strengthen its teams in the United States and Belgium. The exclusivity of this new microfluidic technology applied to neonatal screening will foster the development of the R&D center in Belgium and stimulate innovation within the Belgian biotech ecosystem. These international developments will reinforce the company's historic ecosystem, a point that Benoît Fellin, Head of the Life Sciences Department at Noshaq, is pleased to highlight: ‘This acquisition marks a key milestone in LaCAR's growth and strengthens its international positioning. We're really proud to be following and supporting its development. We are delighted to contribute to this expansion and success, in such a strategic field as neonatal screening.’ “We would like to thank our investors and financial partners (Noshaq, Kazoku, Wallonie Entreprendre International, BNP Paribas Fortis and Belfius) for their trust and support. Thanks to them, we can pursue with great ambition our commitment to innovation and technological progress in the field of neonatal screening” concludes Arnaud Allaer, CEO of LaCAR MDx Technologies. About LaCAR MDx Technologies LaCAR is a Belgian company specialized in the production and commercialization of IVDR diagnostic kits in the fields of pharmacogenetics and neonatal screening, certified ISO 13485 and MDSAP. LaCAR is committed to providing cutting-edge technologies worldwide to improve the quality of healthcare.

并购诊断试剂

2024-03-16

·PRNewswire

Global HIV Point of Care (POC) Tests Pipeline Landscape Report 2023: Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies

DUBLIN, March 15, 2024 /PRNewswire/ -- The "HIV Point of Care (POC) Tests Pipeline by Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies" report has been added to ResearchAndMarkets.com's offering. The report provides comprehensive information about the HIV Point of care (POC) Tests pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. HIV Point of care (POC) Tests is defined as medical diagnostic testing performed outside the clinical laboratory in close proximity to where the patient is receiving care. POC is typically performed by non-laboratory personnel and the results are used for clinical decision making. POC has a range of complexity and procedures that vary from manual methodologies to automated analyzers. POC devices are often 'handheld' or may be small portable analyzers. Scope Extensive coverage of the HIV Point of care (POC) Tests under development The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities The report reviews the major players involved in the development of HIV Point of care (POC) Tests and list all their pipeline projects The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage The report provides key clinical trial data of ongoing trials specific to pipeline products Recent developments in the segment / industry Reasons to Buy Formulate significant competitor information, analysis, and insights to improve R&D strategies Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage Identify and understand important and diverse types of HIV Point of care (POC) Tests under development Develop market-entry and market expansion strategies Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline In-depth analysis of the product's current stage of development, territory and estimated launch date Key Topics Covered: 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 HIV Point of care (POC) Tests Overview 3 Products under Development 3.1 HIV Point of care (POC) Tests - Pipeline Products by Stage of Development 3.2 HIV Point of care (POC) Tests - Pipeline Products by Territory 3.3 HIV Point of care (POC) Tests - Pipeline Products by Regulatory Path 3.4 HIV Point of care (POC) Tests - Pipeline Products by Estimated Approval Date 3.5 HIV Point of care (POC) Tests - Ongoing Clinical Trials 4 HIV Point of care (POC) Tests - Pipeline Products under Development by Companies 4.1 HIV Point of care (POC) Tests Companies - Pipeline Products by Stage of Development 4.2 HIV Point of care (POC) Tests - Pipeline Products by Stage of Development 5 HIV Point of care (POC) Tests Companies and Product Overview 6 HIV Point of care (POC) Tests- Recent Developments 6.1 Oct 10, 2023: Trinity Biotech Welcomes the Decision of the High Court of Kenya to Strike Out the Applications to Prevent the Procurement of Trinscreen HIV by the Kenyan Ministry of Health 6.2 Sep 27, 2023: Update on MedMira's Regulatory Path in Canada and the USA 6.3 Jun 14, 2023: Atomo and Newfoundland Sign Agreement for HIV Testing in Europe 6.4 Mar 22, 2023: Trinity Biotech welcomes TrinScreen HIV's inclusion in the New Kenyan HIV Testing Algorithm 6.5 Feb 28, 2023: Significant purchase order for HIV self-tests for Europe 7 Appendix A selection of companies mentioned in this report includes Abbott Rapid Diagnostics GmbH Aldatu Biosciences Inc Altratech Ltd Atomo Diagnostics Ltd Baebies Inc BBB Technologies Inc Beijing Wantai Biological Pharmacy Enterprise Co Ltd Binx Health Inc Bio-AMD Inc Biocartis Group NV BioHelix Corp Bluejay Diagnostics Inc Calypte Biomedical Corporation Centre International de Reference Chantal Biya Cepheid Inc ChipCare Corp CrossLife Technologies Inc Cue Inc Daktari Diagnostics, Inc. Diagnostics For All Inc Diagnostics for the Real World (Europe) Ltd Endeavor Sciences Inc Epinex Diagnostics Inc ERBA Molecular Ltd Fluxergy LLC GAIA Medical Institute LLC genedrive plc Group K Diagnostics Guangzhou Wondfo Biotech Co Ltd HA TECH Pty Ltd HeatFlow Technologies Inc Identifysensors LLC Imperial College London Integrated Diagnostics Inc (Inactive) Intuitive Biosciences Inc Jan Biotech Inc Jinvator Bio Med GmbH Johns Hopkins University Lynntech Inc Maxim Biomedical Inc MedMira Inc Micronics Inc Molbio Diagnostics Pvt Ltd MyMD Pharmaceuticals Inc Nanobiosym Inc Newmark Diagnostics LLC Northwestern University Osel Inc Philmedi Co Ltd Prenetics Ltd QuantuMDx Group Ltd Quidel Corp Radisens Diagnostics Ltd Rheonix Inc Roche Diagnostics International Ltd Sedia Biosciences Corp Sensible Diagnostics Inc Senzo Inc TheoremDx Inc Trinity Biotech Plc University of Connecticut University of Minnesota UrSure Inc Ustar Biotechnologies (Hangzhou) Ltd. Virax Biolabs Group Ltd Wave 80 Biosciences Inc Yaathum Biotech Pvt Ltd For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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