NOWDiagnostics | NOWDx

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

“Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections." - Robert Weigle, CEO of NOWDx 📰 Quartz, Bruce Gil https://lnkd.in/g4K5mhFW

The countdown to USCHA is on! We’re just a few days away from showcasing the 'First To Know® Syphilis Test' at Booth 702. Be among the first to see how this new test can make a difference in syphilis detection and prevention. #USCHA2024 #FirstToKnow #SyphilisAwareness #Syphilis

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. 📈 Syphilis has resurged at an alarming rate in the U.S. in nearly every demographic group and region, including newborns. According to the Centers for Disease Control and Prevention (CDC), cases increased by 80% to over 207,000 between 2018 and 2022. More than 3,700 cases of congenital syphilis were documented among newborns in 2022—10 times the number diagnosed in 2012. 💉 If untreated, syphilis can seriously damage the heart and brain and cause blindness, deafness, and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues, and infant death. Often, those with syphilis do not notice symptoms. 📰 MedTech Dive, Ricky Zipp https://lnkd.in/dxiHtmfT

We’re excited to announce our presence at two major conferences this September! Join us at USCHA in New Orleans from Sept 12-15 and at the STI Prevention Conference in Atlanta from Sept 16-18. Discover how the newly launched 'First To Know® Syphilis Test' is set to revolutionize STI prevention. #USCHA2024 #STIPrevention2024 #FirstToKnow #SyphilisAwareness #STIPrevention

In a news release, FDA officials expressed hope that the [First To Know®] product will improve access to at-home sexually transmitted disease (STI) testing and increase initial screening for syphilis, reducing the spread or worsening of the infection. 📰 Pharmacy Times, Alexandra Gerlach https://lnkd.in/ekFF877r

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. 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. 📰 Medical Product Outsourcing, Sam Brusco https://lnkd.in/eJnhuA95

The First To Know® test received marketing authorization 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. 📰 MedCity News, Frank Vinluan https://lnkd.in/gsAZ8nBU

"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

“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