FDA authorizes 1st over-the-counter, at-home test for syphilis

The first at-home, over-the-counter antibody test for syphilis received marketing authorization from the U.S. Food and Drug Administration (FDA) on Friday.

This means biotechnology company NOWDiagnostics, Inc., which manufactures the test, now has a license to sell it.

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."

A box, which comes with one test, will be sold for $29.98, and will be available at major retailers in fall 2024, the company told ABC News.

In a clinical study of 1,270 people, the test was able to correctly identify 99.5% of negative specimens and correctly identify 93.4% of positive specimens when compared to three FDA-cleared laboratory tests, the company said.

"We have a great team who worked tirelessly to bring this product to market. They deserve all the credit," Rob Weigle, CEO of NOWDiagnostics, said in a statement to ABC News. "This simple first of its kind screening test could aid significantly in the fight to end this epidemic and bring down the rates of syphilis around the country by allowing anyone to test themselves in the privacy of their own home."

"Over 50% of cases have no symptoms. If you suspect you might have been exposed or have had unprotected sex with someone and don't know their sexual history, you should consider taking this test," the statement continued.

Syphilis is a sexually transmitted infection that can be treated with antibiotics. However, when left untreated, it can cause serious health problems including hearing loss, blindness, nerve damage leading to muscle weakness, damage to the internal organs and even death, according to the Centers for Disease Control and Prevention (CDC).

There's been a dramatic uptick in syphilis cases in the U.S. in recent years, with the CDC reporting a nearly 80% increase from more than 113,000 cases in 2018 to more than 203,000 in 2022.

Additionally, growing number of cases are in babies born to untreated moms, known as congenital syphilis. In 2022, 3,755 babies were born with syphilis in the U.S., an increase from the 1,325 cases among babies in 2019.

Congenital syphilis can cause miscarriage, stillbirth, premature birth and low birth weight. Additionally, babies born with syphilis can have deformed bones, severe anemia, enlarged live rand spleen, skin rashes, jaundice and brain or nerve problems, according to the CDC.