SPRINGDALE, Ark.--(BUSINESS WIRE)--NOWDiagnostics, Inc. (NOWDx), a developer of over-the-counter (OTC) and point-of-care (POC) diagnostic tests, today announced that its First To Know® Syphilis Test—a key tool in syphilis prevention—is now available for purchase nationwide. The first-of-its-kind, self-directed rapid test provides in-home results in 15 minutes with as little as a drop of blood, offering individuals an accurate, easy-to-use, and private way to test for syphilis. First To Know® is the only syphilis test in the U.S. with FDA marketing authorization for OTC use, and it can now be purchased online on Amazon and in thousands of major retail, pharmacy, and drugstore locations across all 50 states.
“The First To Know® Syphilis Test is designed to break down barriers to healthcare access and address the stigma that too often surrounds STI testing. By empowering individuals to test privately and conveniently, anytime and anywhere, we’re supporting public health initiatives focused on expanding access to testing and reducing the spread of syphilis,” said Rob Weigle, CEO of NOWDx. “Thanks to our retail and our Public Health partners, this test is now accessible across the country at an affordable price point—under $30, similar to or less than a typical co-pay—offering a meaningful solution for people who might otherwise delay or avoid testing and enabling them to take control of their health.”
In the U.S., syphilis cases have surged to the highest levels in 70 years. Perhaps most concerning, congenital syphilis cases have skyrocketed by 937% over the past decade. As one of the fastest-growing sexually transmitted infections (STIs) in the U.S., syphilis can cause severe complications if untreated, including blindness, paralysis, and organ damage. When transmitted during pregnancy, it can lead to miscarriage or infant death. Alarmingly, it is estimated that up to 60% of people with syphilis may not know they are infected, as many do not notice symptoms, further contributing to its spread.
“With syphilis cases at critical levels nationwide, accessible testing options like the First To Know® Syphilis Test are more essential than ever,” said Harold Phillips, Deputy Director of Programs at the National Minority AIDS Council (NMAC) and Former Director of the White House Office of National AIDS Policy (ONAP). “For those at risk, including individuals with symptoms or exposure and especially pregnant women, having access to private, convenient testing can make all the difference. We’ve seen with the HIV epidemic that removing barriers to early testing is key to controlling the spread of infection and ensuring timely care, especially for communities disproportionately impacted. Expanding access to tools like this test represents a vital step toward a healthier, more equitable future.”
To learn more about the First To Know® Syphilis Test and find a convenient purchase location near you, visit firsttoknow.com/where-to-buy.
About First To Know® Syphilis Test
The First To Know® Syphilis Test is a patented buffer-less lateral flow device that provides a qualitative rapid membrane immunochromatographic assay for detecting Treponema pallidum (syphilis) antibodies in human whole blood (capillary) from individuals suspected of having a syphilis infection. First to Know® received marketing authorization in August of 2024 from the FDA through the de novo pathway recognizing it as a novel device for syphilis testing in the United States, distinguishing it from other products on the market. In a clinical study of 1,270 people, the NPA (negative percent agreement) was 99.5%, meaning it correctly identified 99.5% of negative specimens; the PPA (positive percent agreement) was 93.4%, meaning it correctly identified 93.4% of positive specimens when compared to three FDA cleared laboratory tests. Results from the First to Know® Syphilis Test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.
About NOWDiagnostics (NOWDx)
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. Please visit nowdx.com for more information.
