Sherlock Biosciences Launches to Provide Better, Faster and More Affordable Diagnostic Testing Worldwide Through Engineering Biology

Sherlock Biosciences, an Engineering Biology company dedicated to making diagnostic testing better, faster and more affordable, announced its launch and initial financing of $35 million. The financing includes a $17.5 million non-dilutive grant and an investment from the Open Philanthropy Project with support from additional undisclosed investors.

Sherlock is using Engineering Biology tools, including CRISPR and Synthetic Biology, to create a new generation of molecular diagnostics that can rapidly deliver accurate and inexpensive results for a vast range of needs in virtually any setting.

“Our founders have created some of the most important breakthroughs in modern science through advances in the field of Engineering Biology, the practice of designing and building biological systems into tools that can enhance human health,” said Rahul K. Dhanda, Sherlock’s co-founder, president and CEO. “We are building Sherlock to transform these breakthroughs into a new and powerful generation of molecular diagnostics that will enable users to make more effective decisions in both clinical and non-clinical settings worldwide – including hospitals, industrial settings, low-resource settings and at home.”

The company takes its name from one of its foundational platform technologies, SHERLOCK™ (Specific High-sensitivity Enzymatic Reporter unLOCKing), which is licensed from the Broad Institute of MIT and Harvard. SHERLOCK was developed by a team led by co-founder and chair of Sherlock’s scientific advisory board Feng Zhang, Ph.D., and collaborators, as a method for identifying specific genetic targets using CRISPR. SHERLOCK can detect genetic fingerprints across multiple organisms or sample types and has been described in four papers published in the journal Science.

The company is also developing INSPECTR™ (INternal Splint-Pairing Expression Cassette Translation Reaction), a Synthetic Biology-based molecular diagnostics platform developed by a team led by co-founder James J. Collins, Ph.D., at the Wyss Institute for Biologically Inspired Engineering at Harvard University. The technology, licensed from Harvard’s Office of Technology Development, can be programmed to distinguish targets based on a single nucleotide without an instrument, at room temperature.

Used as stand-alone tools or in combination, these platforms allow for the detection and quantification of targets without complex instruments and in a variety of potential settings. The flexibility and modularity of these platform technologies open a wide range of potential applications and actionable insights in areas including precision oncology, infection identification, food safety, at-home testing, and disease detection in the field.

The company will employ a strategy of selective partnering and direct product development to apply these technologies into a wide range of settings and applications. The financing will be used to advance development programs and design new assays.

“Engineering Biology-based tools have broad potential to transform not just the treatment of disease but also how diseases are diagnosed,” said co-founder James Collins, Ph.D. “Sherlock Biosciences will make a significant difference in the world by bringing the power of Synthetic Biology and CRISPR to diagnostic development.”

“We believe Sherlock Biosciences offers an enormous opportunity to improve human health worldwide by delivering fast, accurate and simple diagnostic testing. It is especially encouraging that the broad potential of its technologies is matched by co-founders and a team who are deeply experienced scientists, entrepreneurs and clinicians,” said Heather Youngs, program officer for scientific research at the Open Philanthropy Project. “Development of this technology could both reduce viral pandemic threats and benefit healthcare more broadly. We are excited to support Sherlock’s efforts to realize the potential of diagnostics and propel this technology into the mainstream.”

“Our team has the expertise and technology to transform diagnostics with a powerful set of Engineering Biology tools to enable rapid test design and deployment, an essential component of addressing many healthcare needs, including the growing problem of resistant bacteria,” said co-founder Deborah Hung, M.D., Ph.D. “After early experiments, our tools were quickly used in a wide range of geographies with real patient samples, confirming that we can swiftly respond to urgent healthcare needs.”

“We founded Sherlock Biosciences to improve health worldwide through the development of disruptive molecular diagnostics. We are delighted to have the support of the Open Philanthropy Project and our investors as we develop Sherlock’s platforms to achieve that goal,” said co-founder David Walt, Ph.D. “Existing molecular diagnostic tools are often limited in their effectiveness because they are costly, labor-intensive, and are not mobile. We believe that Sherlock is poised to overcome those challenges by creating tests that are faster, less expensive and easier to use than currently available molecular diagnostics.”

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FDA, CDC, and CMS Launch Task Force to Facilitate Rapid Availability of Diagnostic Tests During Public Health Emergencies

The U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.

“Public health emergencies, like Ebola outbreaks, remind us that we’re a global community when it comes to public health protection. Bacteria and viruses don’t respect territorial boundaries. It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. We’re all in this together. To that end, the FDA knows that collaborating with our federal partners to employ our collective expertise, experiences from previous incidents, and resources will better assist in a global response. We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies’ coordination,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “This task force will help our agencies better collaborate to prepare for, and respond to, public health threats, including identifying threats and ensuring the appropriate diagnostics are in place to support efforts in the field.”

The FDA, CDC and CMS each play a critical role in responding to public health emergencies, including identifying threats, regulating medical products, and providing oversight for laboratories. The agencies have robust teams of scientists, researchers and policy experts that are dedicated to preparing the U.S. for rapid disaster response.

Diagnostic tests—such as those that can detect pathogens like the Ebola and Zika viruses—can be quickly made available to meet response needs during a crisis through the Emergency Use Authorization (EUA) process. The FDA has authority to issue an EUA for the use of diagnostic tests during public health emergencies, provided criteria are met. The CDC is responsible for providing agent-specific subject matter expertise in epidemiology, laboratory expertise and guidance to clinicians and laboratories responding to the emergency. The CDC and other federal laboratories are often the ones developing new tests to respond to emergency needs. CMS has authority to ensure quality testing at laboratories through the Clinical Laboratory Improvement Amendments (CLIA). CMS provides guidance, even during public health emergencies, to laboratories on meeting CLIA requirements to ensure laboratories produce accurate, reliable and timely results.

Prior to this partnership, feedback from the clinical laboratory community indicated that there was uncertainty about how to implement the diagnostic tests once they received an EUA; particularly, the community was uncertain about meeting CLIA regulations under an EUA to allow labs to start testing specimens.

“During public health emergencies, ensuring the health and safety of patients through quality laboratory testing will remain the focus of CMS,” said Kate Goodrich, director of the Center for Clinical Standards and Quality and CMS Chief Medical Officer. “Timely implementation of EUA diagnostic assays in the US healthcare system is dependent upon laboratories understanding the instructions for use and applying them to the patient samples received for testing. As part of this taskforce, it is our goal to provide clear and consistent guidance to laboratories on the application of CLIA requirements for these emergency assays.”

By standardizing collaboration efforts, the federal partners hope to address issues related to implementation of diagnostic tests authorized for emergency use under an EUA, as well as other unmet needs and gaps in preparing and responding to global health threats. The task force will provide a forum for each agency to coordinate, provide consultation, and improve the availability of diagnostic tests during public health emergencies. In addition, to assist in public health preparedness, the task force will work to define, refine and streamline interagency approaches for the implementation of EUA diagnostic tests. The hope is that the task force will enable an even more efficient federal government response for making diagnostic tests available in the event of a public health emergency.

“Time and time again, we’re reminded that disease knows no borders. While our globalized world and modern transportation help promote economic prosperity, these features also facilitate the spread of emerging infectious diseases,” said Chesley Richards, CDC’s Deputy Director for Public Health Science and Surveillance. “In the past 15 years alone, we’ve faced serious global outbreaks of deadly pathogens. During public health emergencies, it is critical for diagnostic tests to be made available and adopted quickly into clinical and public health laboratories for rapid patient care.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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