2,500-strong PROMISE Study of Sherlock’s DNA-based test for Chlamydia and Gonorrhea will run in 20 sites across diverse demographics, mirroring STI prevalence
Accelerating screening and reducing disease prevalence through low-cost, easy-to-use and accessible OTC testing
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WATERTOWN, MA, May 30, 2024 – 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 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.
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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,” said 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.
Dr. Barbara Van Der Pol, Professor of Medicine and Public Health at the University of Alabama at Birmingham and the Director of the UAB STD Diagnostics Laboratory said: “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.”
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About Sherlock Biosciences
Sherlock Biosciences is a global health company that is bringing diagnostics answers over the counter and beyond. Sherlock’s molecular diagnostics leverage proprietary CRISPR and Synthetic Biology chemistries to rapidly deliver results anytime, anywhere they are needed, bringing together the lab accuracy of PCR with the convenience and ease-of-use of antigen tests for molecular diagnostics at the point-of-need. Two novel device platforms including a disposable format, deliver affordable, accurate and accessible diagnostics in the home and in low resource settings, opening up a wide range of applications in areas including infectious disease, early detection of cancer, treatment monitoring and precision medicine. In 2020, the company made history with the first FDA-authorized use of CRISPR technology. For more information, please visit www.sherlock.bio.
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