NOWDiagnostics Receives FDA De Novo Marketing Authorization for Over-the-Counter Syphilis Test
The landscape of at-home healthcare has taken a significant leap forward with NOWDiagnostics’ First To Know® syphilis test receiving FDA De Novo marketing authorization for over-the-counter use. This milestone marks a crucial step in providing consumers with faster, more accessible, and affordable testing options.
Now, individuals will have the ability to obtain syphilis test results within the privacy of their own homes, further democratizing health information and promoting early intervention. The test itself is a capillary, blood-based lateral flow immunoassay that produces results in a matter of minutes—offering a robust solution to the growing demand for rapid, reliable, and confidential testing solutions.
In the context of a resurging syphilis epidemic, which has seen a 74% increase in reported cases between 2017 and 2021 in the US, this development holds significant potential in mitigating the spread of the disease. It is particularly critical for pregnant women, as untreated syphilis can lead to serious complications, including miscarriage, stillbirth, and lifelong medical issues for the child.
- Syphilis, a sexually transmitted infection once thought to be in decline, is now exhibiting a disturbing resurgence. This upward trend is underscored by the tenfold increase in congenital syphilis cases over the past decade as reported by the Centers for Disease Control and Prevention (CDC).
- The First To Know test has been specifically designed to meet consumer demand for faster and more accessible testing options. This approach is key to expanding access to critical health information, driving earlier intervention, and ultimately improving health outcomes.
NOWDiagnostics has been poised for this breakthrough, securing strategic investments from prominent partners like the Labcorp Venture Fund. This funding support has been instrumental in driving the company’s mission to bring cutting-edge diagnostic solutions to the market.
As the healthcare landscape continues to evolve, the First To Know syphilis test stands out as a beacon of innovation, offering a new vanguard in the battle against a formidable and increasingly prevalent health threat.
