In a clinical study, the First to Know test correctly identified 99.5% (1158 out of 1164) of negative specimens and 93.4% (99 out of 106) of positive specimens when compared with 3 FDA-cleared ...

Now authorized for professional use in Canada, the iStatis Syphilis Antibody Test offers a fast, accurate, and portable solution to strengthen syphilis screening efforts nationwide.

In the 2 years before the intervention, 296 of 4,764 (6.2%) encounters included testing for syphilis, which increased almost eightfold after the intervention to 2,307 of 4,401 (52.4%).

This approval to begin clinical trials comes at urgent time in Canada, where rates of syphilis have skyrocketed in recent years. In 2022, there were 13,953 reported syphilis cases, with rates ...

The test will likely be positive for individuals who have previously had syphilis, even if they have been treated. The FDA clearance was based on a clinical study (ClinicalTrials.gov Identifier ...

Infectious Disease > STDs FDA OKs First Syphilis Screening Test for At-Home Use — Amid a surge in cases, FDA hopes at-home tests will help increase syphilis diagnosis, treatment by Katherine ...

MedMira’s focus on syphilis is based on the tremendous impact of this sexually transmitted disease on global health. In 2018 alone, the European CDC reported about 34,000 new confirmed cases of ...

As syphilis cases surge throughout the United States, the U.S. Food and Drug Administration on Friday approved the first diagnostic at-home test to spot the bacterial disease.

On 10 July 2025, the World Health Organization (WHO) prequalified the first bundled set of three in vitro rapid diagnostic tests (RDTs) capable of ...