Sherlock Biosciences has enrolled its first patient in the PROMISE trial which evaluates the company’s rapid over-the-counter (OTC) test for sexually transmitted infections (STIs).
The molecular test analyses DNA and RNA which is self-collected through penile meatal or vaginal swabs to test for the presence of chlamydia trachomatis and neisseria gonorrhoeae. Sherlock says that its diagnostic provides results in under 30 minutes. The World Health Organization (WHO) estimates that more than one million curable STIs are acquired every day, with chlamydia and gonorrhoea being the most common STIs.
The PROMISE trial will evaluate the company’s OTC test against the current gold standard for diagnosing STIs, the polymerase chain reaction (PCR) test. The study is expected to enrol approximately 2,500 participants ages 14 years and older who are symptomatic and asymptomatic sexually active.
Sherlock plans to use the data to support a marketing authorisation with the US Food and Drug Administration (FDA). The company plans to seek approval under the OTC in vitro diagnostics under Vitro Diagnostics under guidelines for self-testing at home and will also request CLIA waiver categorisation, signifying that the test is so simple that there is little risk of error.
“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 Sherlock Biosciences president and CEO Bryan Dechairo.
“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.”
GlobalData estimates that the market for in vitro diagnostics to grow to be worth over $35.6bn by 2033. Rapid diagnostics have also increased in popularity, especially following the Covid-19 pandemic.
Multiple companies are developing at-home and rapid testing for STIs. In June 2023, Linear Diagnostics received funding to develop a 20-minute STI test to diagnose gonorrhoea and chlamydia.
In October 2023, UK gynaecological health start-up Daye initiated a clinical trial investigating a tampon capable of detecting human papillomavirus (HPV) and STIs. According to the company, the tampon offers the advantage of collecting a bigger and more comprehensive sample compared with a conventional swab.
