Summary: Sherlock Biosciences has initiated the PROMISE Study, a multicenter clinical trial to assess the performance of their over-the-counter disposable molecular STI test against standard lab PCR testing.
Takeaways:
- Innovative Testing: The Sherlock STI test provides results in under 30 minutes using self-collected swabs, aiming to make STI testing more accessible and rapid.
- Public Health Impact: The study addresses the CDC’s call to prioritize STIs, especially among disproportionately affected groups, and seeks FDA authorization for at-home use.
- Broad Participation: The trial involves 2,500 participants from diverse backgrounds, reflecting the varied demographic impacted by STIs, with the goal of demonstrating the test’s effectiveness for lay users.
Sherlock Biosciences today announced the enrollment of the first participant in the PROMISE Study, a multicenter clinical study to evaluate the performance of the Sherlock STI over-the-counter (OTC) disposable molecular STI test against the gold standard of central lab PCR testing. The Sherlock test is one of the first molecular disposable tests for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG). Test results are provided in under 30-minutes by analyzing DNA and RNA self-collected through penile meatal or vaginal swabs.
This trial comes at a time when the Centers for Disease Control and Prevention has called for STIs to be made a “public health priority.” In 2022 in the U.S., there were about 1.6 million cases of Chlamydia and about 650,000 cases of Gonorrhea. The spread of Chlamydia is especially challenging as it is often asymptomatic and populations like Latino, African American, Native American and men-having-sex-with-men are disproportionately impacted by these STIs.
Further Reading: How Should We Tackle the STI Epidemic?
The PROMISE Study aims to recruit individuals from different backgrounds to ensure that the trial accurately reflects the broad diversity of the STI-impacted population. The study will enroll approximately 2,500 subjects at 20 study sites across the United States and will involve symptomatic and asymptomatic sexually active lay users aged 14 years and up. The study seeks FDA’s marketing authorization for OTC In-Vitro Diagnostics under guidelines for self-testing at home and also requests CLIA waiver categorization.
“There continues to be a major gap in care for those with STIs due to the lack of accessibility to diagnostic testing, especially in underserved populations,” says Bryan Dechairo, president and chief executive officer of Sherlock Biosciences. “Enrollment of the first participant in this clinical trial marks a major milestone for Sherlock and for population health. Our aim is to reach broad, demographic regions and age groups with diverse socioeconomic and educational backgrounds. By aligning the trial with the current infected population, we hope to prove efficacy in the hands of lay users.”
Sherlock’s OTC test has the potential to increase both screening and subsequent treatment rates for two of the most common and curable STIs by providing rapid answers even in the privacy of one’s home.
“This is an exciting study, as affordable, accessible, and accurate at-home testing would be transformative in the fight against STIs. Stigma around STIs has led to fewer individuals getting tested and treated. With faster, more discreet testing we can slow the spread of infections,” says Barbara Van Der Pol, PhD, MPH, professor of medicine and public health at the University of Alabama at Birmingham and the director of the UAB STD Diagnostics Laboratory.
