First To Know Syphilis Test Offers At-Home Diagnosis in 15 Minutes

Traditional syphilis testing often requires clinic or lab visits, posing challenges for individuals seeking privacy or with limited healthcare access. NOWDiagnostics’ First To Know Syphilis Test circumvents these barriers with a convenient, in-home solution offering results in just 15 minutes.

The test, the first of its kind approved for over-the-counter (OTC) use in the US, detects antibodies for Treponema pallidum, the bacterium responsible for syphilis. Using a single drop of blood, it delivers highly accurate results, with clinical trials showing a 99.5 percent accuracy rate for negative cases and 93.4 percent for positive cases. While confirmatory testing is recommended to ensure diagnosis accuracy, this test could provide a critical first step for early detection and intervention.

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Current syphilis diagnostic methods, while widely used, present several challenges that can delay treatment and hinder accessibility. According to the Centers for Disease Control and Prevention (CDC) recommendations for 2024, nontreponemal tests like rapid plasma reagin (RPR) often struggle with sensitivity in early-stage syphilis, potentially missing cases before the immune system mounts a detectable response. Treponemal-specific tests, while more accurate, detect antibodies that persist for life, making it difficult to distinguish between past and active infections without additional testing.

These methods also rely on laboratory infrastructure, specialized equipment and trained personnel, creating accessibility barriers in resource-limited settings. Moreover, test results often take several days, delaying the initiation of treatment. Even newer automated treponemal tests, while promising, remain expensive and out of reach for many public health systems.

NOWDiagnostics CEO Rob Weigle emphasized the test’s potential to expand access to testing by breaking down common barriers like cost and stigma. Priced under $30, lower pricing compared to some of its competitors, it offers an affordable alternative for individuals who might otherwise delay testing. The test is now available online and in thousands of pharmacies, drugstores and retail locations nationwide, providing an accessible option for people across all 50 states.

This launch comes at a critical time. Syphilis rates in the US have reached a 70-year-high, and congenital syphilis cases have increased by 937 percent in the last decade.

According to the World Health Organization (WHO), an estimated eight million adults aged 15 to 49 acquired syphilis in 2022. The infection, which is often symptomless in its early stages, can lead to severe complications such as blindness, paralysis and organ damage if left untreated.

In the press release, Harold Phillips, deputy director of Programs at the National Minority AIDS Council and former director of the White House Office of National AIDS Policy, highlighted how private and accessible testing options are key to reducing the spread of infection, especially when current at-home tests could take several days to receive results.

With no specialized training required and results in minutes, the NOWDiagnostics’ First To Know Syphilis Test could significantly improve outcomes for underserved communities.