FDA Approval Paves Way for First At-Home Syphilis Test by NOWDiagnostics

In a major breakthrough, the US Food and Drug Administration (FDA) has approved the first at-home, over-the-counter test for detecting syphilis antibodies.

The new test, developed by NOWDiagnostics, Inc., promises to make it easier for individuals to screen for syphilis in the privacy of their own homes.

Home Testing for Syphilis Now Available

Syphilis is a sexually transmitted disease that can have serious health consequences if left untreated.

Traditionally, detecting syphilis requires a visit to a healthcare provider for a blood test or testing of fluid from a sore. With the new test, people can now obtain results in about 15 minutes by pricking their finger and testing a small drop of blood, according to Reuters.

The FDA, while approving this new option, has stressed that the test should not be used as the sole method for diagnosing syphilis. Further testing by a healthcare professional is necessary to confirm any results and to ensure an accurate diagnosis.

Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, highlighted the potential benefits of this home test.

Recent data from the US Centers for Disease Control and Prevention (CDC) show a dramatic 80% increase in syphilis cases from 2018 to 2022. This rise includes a troubling increase in cases among newborns, which have surged more than tenfold over the past decade.

In 2022, over 207,000 syphilis cases were reported in the US, the highest number since the 1950s, according to CNN.

Syphilis starts with small sores on the genitals or anus, which can heal on their own but may lead to more severe health issues if untreated. If not treated, it can cause blindness, deafness, and severe damage to the heart and brain. During pregnancy, syphilis can cause miscarriage or serious health problems for the baby.

NOWDiagnostics' Plan to Promote Syphilis Test

NOWDiagnostics is hopeful that their test will help increase testing rates, especially in populations that might face barriers to traditional healthcare settings. The test's approval comes at a time when the public health system is struggling with increasing cases of syphilis and limited resources.

The company plans to use social media and collaborate with retailers to promote the test and raise awareness among key groups, including pregnant individuals and men who have sex with men.

Jeffrey Klausner, a professor of medicine and public health, points out that while the new test will benefit many, it may not fully address the needs of the most vulnerable groups, such as the homeless or undocumented individuals.

These populations often face challenges in accessing healthcare and may remain undiagnosed and untreated, The Washington Post reported.

The test has shown a 93.4% accuracy rate in clinical trials and is designed to be user-friendly. However, there are concerns about ensuring that the test reaches those in greatest need, and the ongoing challenge of accessing affordable and effective treatment for all affected individuals.