FDA Approves First Over-the-Counter Test for Syphilis

FDA Approves First Over-the-Counter Test for Syphilis

The last time I reported on the sexually transmitted disease syphilis, the Centers for Disease Control and Prevention (CDC) reported that the number of syphilis cases has surged to the highest level in seventy years.

Health experts also expressed deep concern about the exploding number of cases of the disease among newborns. Fetal infection with this bacteria can adversely affect various organs and systems, resulting in deformed bones, anemia, and brain disorders. Miscarriages, stillbirths, and low birth weights are also possible outcomes of congenital syphilis.

Now, the Food and Drug Administration (FDA) has approved the first over-the-counter, at-home test for syphilis as a new tool in fighting against the spread of the disease.

Regulators issued the green light for the release of the First To Know Syphilis Test, made by NOWDiagnostics of Springdale, Ariz., noting its status as the first at-home test to detect Treponema pallidum, or syphilis, antibodies in human blood.

They cautioned that results from the home test alone are not sufficient to accurately diagnose a syphilis infection and should be followed by additional testing by medical professionals.

Even so, the approval marks a significant milestone in the detection and treatment of STDs as cases soar across the United States, health officials said.

Biotechnology company NOWDiagnostics, Inc. has a license to sell the over-the-counter test. The privacy aspect is considered a key selling point for this product.

Traditionally, syphilis is detected by a health care provider using a blood test or by testing fluid from a syphilis sore.

However, the new test, called First To Know, uses a drop of blood to offer an early indication that a person may have syphilis, with results available in about 15 minutes. The results must be confirmed by a doctor.

The FDA said the test offers a new option for people who might be unable or reluctant to visit a doctor to get tested.

“Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure,” Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in a statement. “This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection.”

According to reports, a box with one test will cost $29.98 and will be available at major retailers in the fall.

The National Syphilis and Congenital Syphilis Syndemic Federal Task Force was created by the Department of Health and Human Services earlier this year in response to the skyrocketing cases.

The at-home test is part of the department’s strategic plan, which aims to reverse the “dramatic rise” of STIs in the US.

If untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis, according to the CDC.

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