NOWDiagnostics, Inc. (NOWDx) has made a groundbreaking advance in diagnostic testing with the recent approval from the U.S. Food and Drug Administration (FDA) for its First To Know Syphilis Test, marking it as the first rapid syphilis test in the United States to receive De Novo marketing authorization for over-the-counter (OTC) use. This innovative test delivers results in just 15 minutes from a single drop of blood, providing a crucial tool for at-home testing.

Significant Public Health Advancement

The First To Know Syphilis Test has been authorised under the FDA’s De Novo pathway, a regulatory pathway for novel devices that do not have a predicate device. This pathway was chosen due to the test’s unique position as the first of its kind for OTC use in syphilis detection. The test’s approval arrives amidst a significant rise in syphilis cases across the U.S. According to the Centers for Disease Control and Prevention (CDC), the incidence of syphilis has surged dramatically, with cases increasing by 80% from 2018 to 2022, surpassing 207,000 cases. Additionally, there has been a distressing rise in congenital syphilis, with over 3,700 cases reported in 2022, marking a tenfold increase from 2012.

Impact of Syphilis Resurgence

Syphilis, caused by the bacterium Treponema pallidum, has seen a troubling resurgence, affecting various demographic groups, including newborns. The disease can cause severe complications if left untreated, including cardiovascular and neurological damage, and can be transmitted from mother to child during pregnancy, leading to miscarriage, stillbirth, or serious health issues for the infant. Despite its severity, syphilis often goes unnoticed due to the lack of symptoms, making timely testing and treatment critical in curbing its spread.

Features and Validation of the Test

The First To Know Syphilis Test employs a patented buffer-less lateral flow device that offers a qualitative rapid membrane immunochromatographic assay. This innovative approach enables the detection of syphilis antibodies in human whole blood, making the test both simple and effective for at-home use. Clinical trials involving 1,270 participants demonstrated high reliability of the test, with a negative percent agreement (NPA) of 99.5% and a positive percent agreement (PPA) of 93.4% compared to established FDA-cleared laboratory tests.

Rob Weigle, CEO of NOWDiagnostics, highlighted the significance of this development: “The FDA granting De Novo authorization of our First To Know Syphilis Test could not have come at a more critical time in our nation’s efforts to combat the rising rates of syphilis. The ability to test privately and quickly at home is a game-changer in the fight against sexually transmitted infections.”

Dr. Gregory Bledsoe, MD, MPH, MBA, former Surgeon General of Arkansas, also underscored the importance of this advancement: “The authorization of this test represents a vital step in addressing the syphilis epidemic. With the robust data from clinical studies, I am confident in the test’s performance. Increased public awareness about untreated syphilis is essential, especially in underserved communities. An accessible in-home test like this could significantly improve public health outcomes by facilitating timely detection and treatment.”

Broader Implications for Public Health

The introduction of the First To Know Syphilis Test is expected to play a pivotal role in enhancing access to syphilis testing and reducing the burden of the disease. By enabling individuals to conduct tests in the privacy of their homes, the test not only simplifies the diagnostic process but also addresses barriers to testing access. This advancement aligns with broader public health goals to improve early detection and treatment of sexually transmitted infections.

About NOWDiagnostics, Inc.

NOWDiagnostics, Inc. is a leader in developing innovative over-the-counter and point-of-care diagnostic tests. The company focuses on creating user-friendly tests that empower individuals with the ability to perform accurate diagnostic tests at home, thereby improving healthcare accessibility and outcomes.

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