BETHLEHEM, Pa., Dec. 19, 2024 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced the acquisition of Sherlock Biosciences, Inc., a global health company bringing next-generation diagnostics to consumers and healthcare providers.
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.
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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.
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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.
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sherlockbio@consortpartners.com
Preeminent IP position gives Sherlock freedom to operate and commercialize across multiple CRISPR business avenues
Watertown, Mass., Feb. 21, 2023 – Sherlock Biosciences, a company engineering biology to bring next-generation lab-quality diagnostic testing to the point of need, today announced that the U.S. Patent and Trademark Office (USPTO) has granted a patent for the diagnostic use of the Cas12 enzyme, establishing Sherlock as the leader in CRISPR-based diagnostics with freedom to operate in the U.S. Sherlock has exclusive U.S. rights to the patent from Shanghai-based Tolo Biotech, plus additional intellectual property (IP) for Cas12 and Cas13 from the Broad Institute, giving the company the preeminent IP position in the space.
The newly granted patent covers a method for detecting nucleic acids leveraging the collateral cleavage activity of Cas12. Unlike Cas9 – the enzyme commonly used for gene editing and CRISPR-based therapeutics, and the subject of several patent disputes – Cas12 is best suited for detecting DNA and RNA sequences, rather than editing them. Sherlock and its academic co-founders have already demonstrated the potential for flexible, high-accuracy, low-cost Cas12-based detection of diseases, including malaria, tuberculosis and COVID-19.
“Sherlock’s diagnostic tests have the potential to transform the healthcare paradigm by shifting power to consumers. Securing this patent is an important step to deliver powerful, over-the-counter diagnostics so consumers have more control over their healthcare decisions,” said Bryan Dechairo, president and CEO of Sherlock Biosciences. “Our diagnostics rely on novel uses of synthetic biology and CRISPR technology to condense the traditional lab tools into handheld tests. With this patent, on top of our existing agreement with Tolo granting co-exclusivity to Cas12 globally, we have secured our dominant IP position with the most comprehensive portfolio of diagnostic CRISPR patents.”
Sherlock’s CRISPR-based diagnostics rely on a key pair of technologies to detect diseases, covered by the patent: amplification and collateral cleavage. First, a specific nucleic acid signature is amplified so that the guide RNA can find and recognize it within a test sample. Once the guide RNA identifies and binds to the target nucleic acid, the Cas12 enzyme becomes activated and cleaves a fluorescently labeled probe present in the mixture. This cleavage event triggers a reaction which then leads to the release of a fluorescent signature, indicating a positive test.
“With this patent, Sherlock has a clear, unimpeded pathway to commercialization for our CRISPR-based diagnostics,” said Jim Collins, Ph.D., co-founder and board member of Sherlock Biosciences. “The pairing of proprietary amplification technology from the Wyss Institute, as well as the rapid molecular amplification chemistry gained through our recent acquisition of Sense Biodetection, puts us on track to become a global health leader. This dominant and defensible patent position will allow us to establish the necessary market foothold in the U.S. before we bring our rapid, point-of-need diagnostic tests to the rest of the world.”
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.
sherlockbio@consortpartners.com
Companies enhance leadership in molecular diagnostics by pairing Sherlock’s advanced CRISPR, synthetic biology and AI technologies with Sense’s instrument-free diagnostic hardware and rapid molecular amplification chemistries for faster path to commercialization
WATERTOWN, MA., and CAMBRIDGE, UK – February 1, 2023: Sherlock Biosciences, a company engineering biology to bring next-generation diagnostics to the point of need, today announced the acquisition of Sense Biodetection (Sense), a global molecular diagnostics innovator. The acquisition accelerates Sherlock’s go-to-market strategy by adding Sense’s Veros™ instrument-free rapid molecular test platform and manufacturing capabilities, enabling the vision of highly accurate and affordable diagnostics that can be used anytime, anywhere. Terms of the acquisition are not being disclosed.
“This acquisition accelerates Sherlock’s ability to put the most advanced CRISPR-based diagnostics conveniently in the hands of global consumers,” said Bryan Dechairo, President and CEO of Sherlock Biosciences. “The Sense team has done a great job developing and validating their instrument-free diagnostic technology. Together, we can significantly push forward our go-to-market strategy by leveraging Sense’s innovative chemistry and device engineering, combined with our industry-leading molecular technologies to realize our collective vision of democratizing and decentralizing diagnostics.”
Sense received its CE Mark in March 2022 for its Veros COVID-19 rapid, instrument-free molecular test, demonstrating strong clinical performance with high sensitivity and specificity. Coupled with Sherlock’s proprietary engineering biology tools, including the first FDA-authorized use of CRISPR technology, this transaction enables Sherlock to bring highly accurate, advanced, handheld tests to global consumers for a wide range of diseases from respiratory and sexual health to global health outbreak response. Sherlock will integrate Sense’s chemistry, manufacturing and technology into its platform, leveraging the company’s proven development and regulatory experience to expand the capabilities of the Sherlock platform and drive further innovation.
“This is a powerful combination of proprietary and leading technologies and will allow Sense to realize our vision of delivering the future of diagnostic testing to transform healthcare,” said Timothy Still, CEO of Sense. “Joining Sherlock with their novel CRISPR technology was an excellent opportunity and we look forward to advancing our platform to meet the need for testing wherever and whenever it is needed.”
Sense is headquartered in Oxford, UK with facilities in Cambridge UK and Milford, MA. Sense launched its first product, Veros COVID-19, in select European and South American markets, and is actively developing a portfolio of tests for other infectious diseases, complementing Sherlock’s mission to develop diagnostic products that improve human health.
“The potential for this acquisition to impact global health is significant,” added Paul Meister, Partner at Sherlock investor Novalis LifeSciences, and previously Chairman of Thermo Fisher Scientific. “There’s been a lot of speculation that 2023 will see increased M&A activity in the life sciences industry; it’s impressive that Sherlock is leading this trend in the private market.”
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.
Sense Biodetection is a global molecular diagnostics company focused on empowering patients and transforming healthcare access and affordability by bringing lab-quality results through easy-to-use, rapid, disposable molecular tests without the constraints of an instrument. The company’s Veros product platform will enable widespread testing to enhance patient access, improve patient health and lower systemic healthcare costs. Backed by respected investors, such as Koch Disruptive Technologies, Cambridge Innovation Capital, Earlybird Health and Mercia Asset Management, Sense has launched its first product, Veros COVID-19, in select European & South American markets, and is growing rapidly while building a portfolio of tests for other diseases.
Consort Partners for Sherlock Biosciences
sherlockbio@consortpartners.com
Technology Developed with Support from the Bill & Melinda Gates Foundation will Enable Testing in Remote Low- and Middle-income Environments, Expanding Healthcare Access and Improving Global Health
Watertown, Mass., November 29, 2022 – Sherlock Biosciences, a company engineering biology to bring next-generation diagnostics to the point of need, today announced that it has received additional funding from the Bill & Melinda Gates Foundation to advance its rapid, instrument-free molecular diagnostic testing platform.
Funding from the foundation has supported platform advancements that are addressing critical gaps in current solutions including the need for portable, disposable, low-cost diagnostic tests that can be deployed in low-resource environments.
“We are deeply grateful for the support of the Bill & Melinda Gates Foundation, as we seek to disrupt diagnostics by providing accurate, actionable information wherever and whenever it is needed,” said Bryan Dechairo, president and CEO of Sherlock Biosciences. “In addition to the development of chemistries for expanding our assay menu, the funding will support integration of all functions with a model system on a prototype device, a critical milestone to making these powerful diagnostic products accessible to people at the point of need.”
Sherlock’s novel CRISPR-based nucleic acid detection method enables highly accurate and low-cost detection of DNA and RNA. The objectives of this project are to leverage many of the innovations enabled by the foundation’s support, while advancing non-instrumented execution and interpretation of the assay. The resulting platform for molecular diagnostics will have increased specificity and sensitivity for multiplexed detection of multiple infectious disease targets from a single patient sample. For low- and middle-income countries that may not have access to large centralized testing facilities, this solution represents a powerful addition to global testing capacity.
“We founded Sherlock Biosciences with a commitment to leveraging the power of disruptive molecular diagnostics to improve global health,” said David Walt, Ph.D., co-founder and board member of Sherlock Biosciences. “The continued support by the Bill & Melinda Gates Foundation is a testament to the importance of this mission and our belief that driving access to accurate, low-cost molecular diagnostics in low-resource areas has the potential to transform lives.”
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.