SAN JOSE, Calif.,March 28, 2025 -- Today, Visby Medical™, a leading innovator in medical diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the Visby Medical Women's Sexual Health Test for Over the Counter (OTC) use. This groundbreaking test enables reliable, rapid, and private at-home testing for Chlamydia, Gonorrhea, and Trichomoniasis—the three most common curable sexually transmitted infections (STIs).

The CDC confirmed a human case of avian influenza A(H5) in Missouri, with the patient now recovered. No animal exposure or transmission has been identified. This is the 14th U.S. case of H5 in 2024 and the first without known animal contact. The CDC continues to assess the situation, but the public risk remains low. Further testing is ongoing.

Monkeypox is a growing concern, with over 15,000 cases and 527 deaths in the Democratic Republic of Congo in 2024. India remains vigilant despite no new cases, while nearby Pakistan has reported a few. Key symptoms include fever, rash, and swollen lymph nodes. Prevention focuses on hygiene, isolation, and vaccination for high-risk groups. Vulnerable populations, such as children and the elderly, are at greater risk, underscoring the need for early detection and preventive measures.

The Visby Medical Sexual Health Test significantly reduces the time to diagnose and treat STIs compared to traditional lab-based tests. A study from Johns Hopkins found that the point-of-care (POC) PCR test, providing results in just 47 minutes, led to more accurate antibiotic use and shorter emergency department stays. The test's faster diagnosis helps reduce over-treatment and antimicrobial resistance. This marks a shift towards quicker, more effective STI management.

with full laboratory automation in a high-volume reference laboratory setting...