Detection of viral RNAs at ambient temperature via reporter proteins produced through the target-splinted ligation of DNA probes
Real-Time, Multiplexed SHERLOCK for in Vitro Diagnostics
Sherlock at Apex of CRISPR-based Diagnostics after USPTO Grants Earliest Priority Patent
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.”
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
sherlockbio@consortpartners.com
Sherlock Bio to buy UK firm in quest for CRISPR-based handheld diagnostic tests
Sherlock Biosciences Acquires Sense Biodetection to Commercialize Disposable CRISPR-Based Diagnostics
Sherlock Biosciences Acquires Sense Biodetection Advancing CRISPR-Based Diagnostics for Consumers
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.”
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.
About Sense Biodetection
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.
Media Contact
Consort Partners for Sherlock Biosciences
sherlockbio@consortpartners.com
Sherlock Biosciences Receives Grant to Advance Development of Power-free Diagnostics
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.”
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.