We are very pleased to announce that today, our First To Know® Syphilis Test received FDA De Novo Marketing Authorization for Over-the-Counter (OTC) Use. First To Know® is the first and only rapid syphilis test in the U.S. that provides an in-home result in 15 minutes with a single drop of blood. “FDA granting De Novo authorization of our First To Know® Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis. Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.” — Robert Weigle, CEO of NOWDx. "This FDA authorization is a significant milestone in addressing the syphilis epidemic. After reviewing the robust data from the clinical studies, I am impressed with the test's performance. There is a critical need to increase public awareness about the seriousness of untreated syphilis, especially in underserved and marginalized populations. An in-home test like this has the potential to greatly impact public health by improving access to timely detection and treatment." — Dr. Gregory Bledsoe, MD, MPH, MBA, former Surgeon General for Arkansas. Learn more about today’s announcement: https://lnkd.in/g47CWk6B #SyphilisTest #HealthAwareness #StayInformed #FirstToKnow #OverTheCounterTest #PublicHealth #EarlyDetection #HealthMatters #BeProactive #InHomeTesting
NOWDiagnostics | NOWDx
Herstellung medizinischer Geräte
SPRINGDALE, AR 2,933 followers
In Home Test – In Home Result – In Minutes
Über uns
NOWDiagnostics (NOWDx) develops and manufactures over-the-counter (OTC) and point-of-care (POC) diagnostic tests. Its patented approach enables virtually any immunological assay to be accurately performed onsite in one step using a small amount of capillary blood, yielding results in minutes. With over 75 patents issued and pending, NOWDx's First To Know® and ADEXUSDx® product lines are available in markets worldwide. Founded in 2013, with headquarters and manufacturing in Springdale, Arkansas, NOWDx envisions a world where people have greater access to in-home testing with results in minutes. The company’s investors include Kompass Kapital Management, DigitalDx Ventures and the Labcorp Venture Fund. NOWDx is committed to changing healthcare by providing accessible, affordable, and accurate testing for all.
- Website
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http://www.nowdx.com
External link for NOWDiagnostics | NOWDx
- Industrie
- Herstellung medizinischer Geräte
- Größe des Unternehmens
- 11-50 Mitarbeiter
- Hauptsitz
- SPRINGDALE, AR
- Typ
- In Privatbesitz
- Gegründet
- 2013
- Spezialitäten
- Medical Clinic Support
Standorte
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Primäre
1200 STEWART PLACE
SPRINGDALE, AR 72764, US
Employees at NOWDiagnostics | NOWDx
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Amy Summy
EVP, Chief Marketing Officer and Consumer Business Lead - Labcorp
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Stephen Tang
30+ years as Chairman, CEO, Founder. Business & Civic Leader. Value professional will, dignity, and personal humility.
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Jeremy W. Wilson
Managing Partner, NewRoad Capital Partners
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Claire England
Investment Partner at GPG Ventures | Kauffman Fellow
Aktualisierungen
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"An in-home test like this has the potential to greatly impact public health by improving access to timely detection and treatment." - said Dr. Gregory Bledsoe, MD, MPH, MBA, former Surgeon General for Arkansas 📰 New York Post, Deirdre Bardolf https://lnkd.in/e9Fs-mCN
FDA approves $30 at-home syphilis test in US as cases see disturbing spike: report
nypost.com
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“Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.” - Dr. Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health 📰 The Hill, Eden Teshome https://lnkd.in/e4JEYNWJ
FDA gives green light to first at-home syphilis test as cases rise
https://thehill.com
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NOWDx is committed to changing healthcare by providing accessible, affordable, and accurate testing for all. 📰 Yahoo, Kaitlin Reilly https://lnkd.in/g2Ck9R9n
Syphilis cases are on the rise. The FDA just approved a home test that could combat that.
yahoo.com
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"We have a great team who worked tirelessly to bring this product to market. They deserve all the credit. This simple first of its kind screening test could aid significantly in the fight to end this epidemic and bring down the rates of syphilis around the country by allowing anyone to test themselves in the privacy of their own home." - Robert Weigle, CEO of NOWDx 📰 ABC News, Mary Kekatos, Sony Salzman https://lnkd.in/g2J9UGHj
FDA authorizes 1st over-the-counter, at-home test for syphilis
abcnews.go.com
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We are excited to announce that Susan Ward is stepping into the role of Director of Marketing at NOWDx, where she will lead strategic marketing and product management initiatives to elevate brand visibility and drive product growth. With her extensive expertise in IVD diagnostics, Susan will be focused on promoting the First To Know® Syphilis Test (https://bit.ly/3Au6EJL). #syphilis #test #marketing #newhire #testing #inhomeresult #diagnostics #nowdx #firsttoknow
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We are thrilled to announce that T.J. Rivetti has joined our NOWDx leadership team as Director of Sales, Public Health. T.J. will cultivate relationships with public health departments and STI-funded agencies throughout the U.S. to achieve the sales goals of NOWDx, with a focus on our First To Know® Syphilis Test. #syphilis #test #publichealth #newhire #testing #inhomeresult #diagnostics #nowdx
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First To Know® is the first and only rapid syphilis test in the U.S. that provides an in-home result in 15 minutes with a single drop of blood. NBC News https://lnkd.in/gVxjKYD3
FDA authorizes first at-home syphilis test
nbcnews.com
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“FDA granting De Novo authorization of our First To Know® Syphilis Test could not have come at a more important juncture in our country’s efforts to slow the rise of syphilis." - Robert Weigle, CEO of NOWDx. 📰 Conor Hale, Fierce Biotech https://lnkd.in/g-m8z2vg
FDA clears its first at-home blood test for syphilis
fiercebiotech.com
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"There is a critical need to increase public awareness about the seriousness of untreated syphilis, especially in underserved and marginalized populations. An in-home test like this has the potential to greatly impact public health by improving access to timely detection and treatment." - Dr. Gregory Bledsoe, MD, MPH, MBA, former Surgeon General for Arkansas First To Know 📰 The Washington Post, Rachel Roubein https://lnkd.in/gPMJE6B3
FDA clears first at-home syphilis test amid surge in cases
washingtonpost.com