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

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.

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.”

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. 

Media Contact

sherlockbio@consortpartners.com

Support from the Bill & Melinda Gates Foundation will improve access to Human Papillomavirus testing, with a focus on remote environments and economically-challenged populations

WATERTOWN, MA, September 12, 2023 — Sherlock Biosciences, a company engineering biology to bring next-generation diagnostics over the counter and beyond, today announced that it has received additional funding from the Bill & Melinda Gates Foundation to advance rapid, instrument-free molecular diagnostics for Human Papillomavirus (HPV). The World Health Organization reports that “cervical cancer is the fourth most common type of cancer in women, and more than 95% of cervical cancer is caused by sexually transmitted HPV.”

Amid a global surge in sexually transmitted infections (STIs), new approaches to diagnostics are urgently required and Sherlock Biosciences is addressing critical gaps in global healthcare through the development of portable, disposable, low-cost diagnostic tests that deliver immediate lab-quality results without the need for laboratories.

“This support will further promote Sherlock’s mission to bring the most advanced diagnostic technologies to the most remote or underprivileged environments. We are delighted that the Gates Foundation is extending their support to Sherlock and bringing focus to HPV, one of the fastest-growing, treatable diseases worldwide,” said Bryan Dechairo, President and Chief Executive Officer of Sherlock Biosciences.

Sherlock Biosciences has previously received grants from the Gates Foundation to develop chemistries to expand its assay menu, as well as $5 million in 2020 to develop a CRISPR-based assay for SARS-CoV-2.

Sherlock’s molecular detection enables PCR-quality results, untethered from a central laboratory. Sherlock’s diagnostics can deliver robust high-sensitivity amplification in under five minutes, bringing healthcare closer to people and providing results when they need them. Sherlock’s disposable format brings down the cost of diagnostics and enables global reach, especially in under-served low-resource settings, for better management of disease outbreaks such as HPV.

“Sherlock is at the forefront of global disease detection and diagnosis and we’re delighted that the Gates Foundation continues to support our mission ,” said Jim Collins, Ph. D., co-founder and board member of Sherlock Biosciences. “HPV infection is a global problem with cervical cancer being one of the major reasons for higher rates of mortality for women. Yet, it is highly treatable if detected early. Advanced diagnostics are essential for early detection, which is why this grant is so important.”

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 SynBio 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.

Contact

sherlockbio@consortpartners.com

Cambridge-based manufacturing facility will support production of 5 million diagnostic devices, with capacity to grow, as the company approaches commercialization

CAMBRIDGE, UK and WATERTOWN, MA, August 15, 2023 — Sherlock Biosciences, a company engineering biology to bring next-generation diagnostics over-the-counter and beyond, today announced the launch of its new biomanufacturing facilities, located outside of Cambridge, UK. The state-of-the-art 36,000 square foot manufacturing facility will expand Sherlock’s global diagnostic capacity in the lead-up to commercialization.

“The opening of this new facility is the latest milestone following Sherlock’s acquisition of Sense Biodetection earlier this year,” said Bryan Dechairo, CEO of Sherlock. “Since then, while preparing the biomanufacturing center, we’ve been melding our teams together, as well as integrating chemistry, manufacturing capabilities and technology. We’re excited to enter this next phase together and are poised to change the course of global health.”

The campus includes a purpose-built, ISO 13485-certified 36,000 square foot manufacturing facility, featuring Class 8 clean rooms where Sherlock is currently validating production capabilities for proprietary disposable molecular diagnostic devices, lyophilized reagent beads and carbon particle lateral flow strips. The facility enables Sherlock to rapidly and flexibly scale low-cost manufacturing of its affordable, accurate and accessible molecular diagnostics across several years of commercial growth.

“We built this facility with a pragmatic approach to scale-up, ensuring we had capacity for what the company needs at each stage of its growth,” said Kristin Riley Sherlock’s VP, Operations. “Central to our design was our commitment to ensuring that we deliver affordable diagnostics to the world, and because of the scale and infrastructure of this facility we can deliver on this commitment today and in the future.”

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 SynBio 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.

Contact
sherlockbio@consortpartners.com

Company Expands Leadership Team on Heels of Recent $80 Million Series B Financing

Boston, Mass. – April 7, 2022 Sherlock Biosciences, a company engineering biology to bring next-generation diagnostics to the point-of-need, today announced that industry veteran Karen Davies has been appointed to its executive team as Chief Development Officer. In her new role at Sherlock Biosciences, Davies will serve as a member of the company’s executive leadership team and will lead product development, reporting to Bryan Dechairo, President and CEO of Sherlock Biosciences.

“Karen joins Sherlock at an exciting time as we leverage our recent $80 Million in Series B Financing to drive development of products, enabled by our decentralized diagnostic platform, that will break down barriers and bring diagnostics to the point-of-need,” said Bryan Dechairo, CEO and President, Sherlock Biosciences. “She is a medical diagnostics and device development veteran, with a strong and proven track record of driving innovation across a broad spectrum of diagnostic platforms. I have no doubt she will be instrumental in advancing our strategy and bringing these products to the world.”

Karen joins Sherlock with more than 30 years of medical diagnostics and device development experience, honed at organizations including Gen-Probe, Abbott, Dura Pharmaceuticals and Quidel. While at Quidel, Karen served as Vice President of instrument systems, where she was responsible for product architecture and development, as well as Vice President of business transformation, where she was responsible for internal process improvement and global commercial communications associated with M&A transactions. Over her career, Karen has held key leadership roles as part of launch teams for multiple diagnostic platforms, from the central lab to point-of-care and over the counter to consumers.

“I joined Sherlock because I not only saw a unique opportunity to advance truly novel technology and bring it to market, but because I believe in the Sherlock team’s ability to deliver results to the point-of-need,” said Davies. “The Sherlock team understands that while our products have broad application potential to democratize diagnostics, we need to be highly focused on defining what will drive consumer adoption of the products that will ultimately bend the curve on population health.”

Ms. Davies holds a Bachelor of Science degree in Mechanical Engineering from Stanford University.

About Sherlock Biosciences
Sherlock Biosciences is developing products that will empower people to access answers and have more control over their health decisions. Through our engineering biology tools, CRISPR-based SHERLOCK™ and synthetic biology-based INSPECTR™, we are bringing together the accuracy of PCR with the convenience and simplicity of antigen tests for molecular diagnostics at the point-of-need. SHERLOCK and INSPECTR can be used in virtually any setting without complex instrumentation, making it well suited for use in the home and in low resource settings, opening up a wide range of potential 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.

Contact
Dean Mastrojohn, Goodfuse Communications
dean.mastrojohn@goodfuse.com