Today, we are pleased to announce that the CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test has received FDA 510(k) clearance for both OTC and Rx versions. Transitioning from EUA to 510(k) clearance marks an important regulatory milestone, supporting continued market availability beyond the emergency authorization framework and reaffirming CorDx’s commitment to quality, regulatory compliance, and accessible respiratory diagnostics. With both OTC and Rx versions cleared, the test offers flexible testing options for consumers and healthcare professionals across home and clinical settings. One test. Three respiratory pathogens. Advancing accessible respiratory diagnostics. For stock availability and pricing information, please contact your Sales representative. #CorDx #TyFast #FDA510K #COVID19 #Influenza #MultiplexTesting #RapidDiagnostics
CorDx
Biotechnology Research
Alpharetta, Georgia 32,633 followers
A global diagnostics organization delivering answers when you need them most.
About us
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
- Website
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https://cordx.com/
External link for CorDx
- Industry
- Biotechnology Research
- Company size
- 1,001-5,000 employees
- Headquarters
- Alpharetta, Georgia
- Type
- Privately Held
- Founded
- 2006
Employees at CorDx
Locations
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Primary
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5900 Windward Pkwy W
Alpharetta, Georgia 30004, US
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9540 Waples St
Unit C
San Diego, California 92121, US
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Beijing, 102433, CN
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Dubai, AE
Updates
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🍂 Hayrides, pumpkin patches, bonfires, apple orchards. Fall is prime season for outdoor plans, and unfortunately, still prime season for bug bites. The AL21 Insect Bite Healer uses gentle heat technology to relieve itching and discomfort fast; no creams, no chemicals, just quick relief so you can get back to enjoying the season. Don't let one itchy bite cut your fall fun short. 🎃 Link in comments 🍁 #FallSeason #InsectBiteRelief #OutdoorSafety #AL21
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📦 A reliable diagnostics partner should be the standard. CorDx distributors get access to a full line of point-of-care and OTC rapid tests, backed by a vertically integrated supply chain designed to support consistent fulfillment. From infectious disease to fertility to substance abuse testing, our catalog is built to meet demand across the healthcare and retail channels you serve. If reliable supply has been the missing piece in your distribution business, let's talk. Link in comments 📦 #BecomeADistributor #Diagnostics #SupplyChain #Partnership
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🎀 October is Breast Cancer Awareness Month, a reminder that early detection remains one of the most powerful tools we have. At CorDx, we believe access to health information, and the diagnostics that support it, should never be complicated. This month, we're using our platform to amplify that message. Talk to your provider about a screening schedule that's right for you. #BreastCancerAwareness #EarlyDetection #WomensHealth #HealthEducation
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🤧 "Is it a cold, the flu, or COVID-19?" is a common question during respiratory season. The CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test detects and differentiates Flu A, Flu B, and COVID-19 antigens from a nasal swab, with results in 10 minutes. When answers can't wait, neither should your testing. Link in comments 👇 #FluSeason #RapidTesting #AtHomeTesting #Diagnostics #OTC
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Congratulations to Liangfang Zhang, professor and Chair of the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at UC San Diego, on being named a 2026 MacArthur Fellow. Known as the MacArthur “genius grant,” the fellowship from the MacArthur Foundation provides $800,000 in unrestricted funds over five years. Professor Zhang is being recognized for his pioneering work in nanomedicine and his development of cell-mimicking nanoparticles with the potential to transform how diseases are treated. His research exemplifies what can happen when bold scientific ideas are pursued with a clear vision for real-world impact. Professor Zhang’s journey from fundamental discovery to technologies with potential clinical applications is a powerful example of that vision in action. We are honored to celebrate this achievement and look forward to seeing how Professor Zhang and his team continue to advance nanomedicine and improve human health. Congratulations, Professor Zhang, on this well-deserved recognition!
Congratulations to Liangfang Zhang on being named UC San Diego's latest MacArthur Fellow! Known as the MacArthur "genius grant," the fellowship from the MacArthur Foundation provides $800,000 in unrestricted funds over five years. Zhang, professor and chair of the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering, is being honored for his pioneering work in nanomedicine to create cell-mimicking nanoparticles to treat disease. His invention is a kind of cellular disguise. He takes membranes from human cells and uses them to cloak tiny, biodegradable particles about one-thousandth the width of a human hair. Armed with these disguises, the cell-mimicking nanoparticles can deliver medicines to targeted sites in the body; act as “nanosponges” that absorb and toxins and other disease-causing molecules; block viruses from replicating; and much more! “This honor means a great deal to me,” Zhang said. “It recognizes 16 years of work by my team to take cellular nanoparticle technology from an early discovery to a platform that has influenced the field and may ultimately benefit patients.” There is a personal dimension to Zhang’s drive to turn laboratory ideas into practical technologies. When he joined UC San Diego in 2008, his laboratory was first housed in the UC San Diego Moores Cancer Center. Every day, he would see dozens of cancer patients pass through the building. “That environment provided a natural intersection between engineering and medicine,” Zhang said. “Seeing so many people suffering, I couldn’t help but think about what I could do to improve medicine. As a scientist, I felt a responsibility to do something that could make a difference.” Zhang is committed to that mission. One of the biotech startups he co-founded, Cellics Therapeutics, Inc., is working to translate the nanosponge technology toward clinical studies and treatments for bacterial infections, autoimmune diseases and inflammatory diseases. “We’re also looking to use the cellular nanoparticles to neutralize a wide variety of pathogens, including bacterial toxins and viruses,” Zhang said. Learn more in the video below, courtesy of the MacArthur Foundation, and in our news story: https://lnkd.in/gSMmJxCe Video description: Liangfang Zhang in his lab at UC San Diego's Franklin Antonio Hall. The clips show Zhang working in the lab, speaking to the camera, and interacting with other scientists in his research group.
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Today, we are pleased to announce that the CorDx TyFast Respiratory Antigen Combo Rapid Test (Flu A/B/COVID+ADV/RSV+PIV/HMPV) is now CE marked under the EU IVDR, supporting its availability for the European market. The test is intended for the qualitative detection of respiratory antigens associated with seven common respiratory pathogens — Influenza A, Influenza B, SARS-CoV-2, Adenovirus (ADV), Respiratory Syncytial Virus (RSV), Parainfluenza Virus (PIV), and Human Metapneumovirus (HMPV) — in human nasal swab specimens, as an aid in the diagnosis of respiratory infection in individuals with respiratory symptoms, including fever, sore throat, cough, and rhinorrhea. Designed for at-home self-testing by individuals with respiratory symptoms, this non-automated chromatographic immunoassay provides visual results at 10 minutes, helping users test for multiple respiratory pathogens that may present with similar symptoms. One test. Seven respiratory pathogens. Results in 10 minutes. Designed for respiratory season! #CorDxTyfast #IVDR #CEMarking #RespiratoryTesting #RapidTest #AntigenTest #OCT #Diagnostics #IVD
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Respiratory season comes back every year on a predictable timeline. The facilities that handle it well plan for it months ahead. 📋 Our latest post breaks down the 5 questions healthcare providers ask most about flu, RSV, and COVID-19 season, and how to get ahead of it. Read more: https://lnkd.in/e99tU7g6 #FluSeason #RSV #COVID19 #POCTesting
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Reliable supply is the whole business. 📦 CorDx distributors get access to a full line of rapid tests backed by global regulatory authorizations and a manufacturer with a vertically integrated supply chain from raw materials to finished product. Reliable supply. More confidence in lead times. Start the conversation: https://lnkd.in/eByQ38AJ #BecomeADistributor #Diagnostics #SupplyChain #PartnerWithCorDx
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Backpacks, lunchboxes, and the first classroom cold of the year, right on schedule. 🤧 When flu and COVID-19 symptoms overlap, guessing isn't a plan. CorDx's TyFast Flu A/B & COVID-19 test delivers reliable results from one comfortable swab in as little as 10 minutes, so families and providers can act fast instead of waiting it out. Learn more: https://lnkd.in/eTQCCtu3 #BackToSchool #RespiratoryHealth #RapidTesting #TyFast
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