The First to Know Syphilis Test, manufactured by NOWDiagnostics, is the first over-the-counter home test for this sexually transmitted disease approved by the U.S. Food and Drug Administration (FDA). Photo courtesy of NOWDiagnostics
Aug. 16 (UPI) – The U.S. Food and Drug Administration approved the first over-the-counter syphilis home test on Friday in response to the rising number of cases of the sexually transmitted disease across the country.
Regulatory authorities gave the green light for the release of the “First To Know Syphilis Test” from NOWDiagnostics of Springdale, Arizona, pointing out that it is the first home test to detect antibodies against Treponema pallidum (syphilis) in human blood.
They warned that home test results alone were not sufficient to confidently diagnose syphilis infection and that additional testing by healthcare professionals should follow.
Still, the approval represents an important milestone in the detection and treatment of sexually transmitted diseases at a time when the number of cases is rising rapidly across the United States, health officials said.
“Access to home testing can help increase initial screening for syphilis, including among people who are reluctant to see their health care provider about possible sexually transmitted infection,” said Dr. Michelle Tarver, deputy director of the FDA’s Center for Devices and Radiological Health. “This can lead to increased laboratory testing to confirm the diagnosis, which in turn can lead to increased treatment and a reduction in the spread of infection.”
Syphilis can cause severe heart and brain damage and, if left untreated, can cause blindness, deafness and paralysis. If transmitted during pregnancy, it can result in miscarriages, lifelong health problems and death of the child.
It is one of the most serious sexually transmitted diseases and is currently experiencing a massive resurgence. The U.S. Centers for Disease Control and Prevention reported that syphilis cases increased 80% between 2018 and 2022, from 115,000 to over 207,000, reaching their highest level since the 1950s.
The situation has become so worrying that the Ministry of Health established the National Syphilis and Congenital Syphilis Syndrome Federal Task Force in January to address the problem.
“The syphilis crisis in our country is unacceptable,” said HHS Secretary Xavier Becerra. “The Biden-Harris administration is committed to addressing this urgent problem and using all available tools to eliminate disparities in our health care system.”
