US authorizes first home test for three common sexually transmitted infections
The home test, developed by privately held company Visby Medical, does not require mailing samples to a lab like other existing home-based STI tests.
The new test for common STIs chlamydia, gonorrhea, and trichomoniasis, which is intended for females with or without symptoms, delivers results in about 30 minutes.
All three infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility, the FDA said.
Visby's single-use test includes a collection kit and a powered testing device, which communicates securely with the Visby Medical App to display results when the test is complete.
"Expanding access to tests for STIs is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection," said Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health.
The common STIs caused by different pathogens have distinct symptoms such as painful urination, lower abdominal pain, heavy menstrual bleeding, and itching or irritation in the genital area.
More than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023, according to a report on STIs from the Centers for Disease Control and Prevention (CDC).
It is estimated that trichomoniasis is the most prevalent non-viral STI worldwide, affecting about 2.6 million people in the U.S., according to the CDC.
Last year, the FDA authorized the first at-home, over-the-counter test to detect syphilis antibodies in human blood.
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