Companies Partner to Develop Instrument-Free Molecular Diagnostic Tests

Sherlock Biosciences and Mologic Ltd., are collaborating to revolutionize molecular diagnostic testing in low-resource settings and within the home. The work is being facilitated by the Bill & Melinda Gates Foundation through an expansion of an existing grant to Mologic. Through the partnership, Mologic will expand its presence in Cambridge, Mass., as part of a joint development center that will be built within Sherlock’s lab space. The companies will combine Sherlock’s core synthetic biology platform with Mologic’s advanced lateral flow expertise to develop simple, sophisticated molecular diagnostics for use at the point of need.
 
Supporting endeavors to create a new field of molecular diagnostics and facilitate more targeted therapies, the funding from the Gates Foundation will bolster efforts to leverage Sherlock’s synthetic biology-based INSPECTR platform and Mologic’s core immunoassay platforms—ELTABA for enzyme activity detection, and CARD, the high sensitivity lateral flow technology developed at Mologic’s Centre for Advanced Rapid Diagnostics. This work will advance affordable, universal detection platforms that will detect DNA or RNA targets in virtually any decentralized site, including low-resource settings and home-based testing. Mologic established its CARD platform with prior funding and support from the Gates Foundation.
 
This collaboration will enable Mologic to expand its presence in the United States, where it has already established a New England subsidiary. By building out a joint development space with equipment and staff, Mologic will establish full immunoassay research and development capabilities and enhance its ability to provide service and support to its U.S.-based partners.
 
“Our INSPECTR platform was designed to be the very first low-cost, rapid, instrument-free molecular diagnostic system to truly address diagnostic needs where solutions do not exist today, especially in low-resource and home settings,” said Rahul K. Dhanda, Sherlock’s co-founder, president, and CEO. “This program will enable us to build on the power of our INSPECTR platform to create diagnostic tools that provide accurate and affordable results in virtually any setting, while working with Mologic and the Bill & Melinda Gates Foundation to develop lateral flow technology to improve global health.”
 
“We believe there is a powerful synergy between Mologic and Sherlock, and we are delighted to have the Gates Foundation support our efforts to combine our first- and best-in-class technology platforms for nucleic acid sensing, super-antibody engineering, ultra-sensitive lateral flow assays, and enzyme activity detection,” said Mark Davis, Mologic’s CEO and co-founder. “By leveraging both companies’ core technologies, we believe we can create extremely sensitive diagnostic tests that produce results with unprecedented speed, without requiring instrumentation, thermal amplification or electricity.”
 
Sherlock Biosciences’ INSPECTR (Internal Splint-Pairing Expression Cassette Translation Reaction) platform leverages the power of synthetic biology by using cell-free systems as programmable molecular diagnostic devices. INSPECTR enables the creation of instrument-free, simple-to-operate diagnostic tests that can be applied across multiple diseases and used in a variety of settings.
 
Mologic’s patented enzymatic activity platform ELTABA (Enzymatic Ligand Transformation Affinity Binding Assay) enables highly specific and sensitive measurement of enzymes outside of the laboratory and in the hands of untrained users. The system works by detecting substrate cleavage sites with a specific antibody that is captured and developed in a traditional lateral flow immunoassay format. This technology enables amplification of signal and a more specific interaction compared to simple antigen detection.
 
Mologic’s Centre for Advanced Rapid Diagnostics (CARD) was established in 2016 with support from the Bill & Melinda Gates Foundation to redefine and re-engineer the critical components of the lateral flow immunoassay. In 2018, CARD succeeded with the aim of developing a rapid, ultra-sensitive, visually read and electricity free detection platform. First demonstrated with malaria and HIV as exemplars, the step change improvements in lateral flow technology resulted from improvements to the engineering of super-antibodies, the deployment of a novel nanoparticle as an alternative to gold, and innovations in assay choreography and smart design. The CARD platform is now being deployed across Mologic’s internal portfolio and for external clients through its services division.
 
Sherlock Biosciences is dedicated to making molecular diagnostics better, faster and more affordable through engineering biology platforms. The company is developing applications of SHERLOCK, a CRISPR-based method to detect and quantify specific genetic sequences, and INSPECTR, a Synthetic Biology-based molecular diagnostics platform that is instrument-free. SHERLOCK and INSPECTR can be used in virtually any setting without complex instrumentation, opening up a wide range of potential applications in areas including precision oncology, infection identification, food safety, at-home tests and disease detection in the field. 
 
Mologic develops advanced lateral flow and rapid diagnostic technologies. Leveraging its core technology platforms, the company works with global organizations, researchers and clinicians to help them deliver fast, reliable and accurate diagnosis at the point-of-care. Mologic’s founder, professor Paul Davis, was the originator of the Clearblue pregnancy test that was launched in 1988 as the world’s first commercial application of lateral flow technology. The creativity, insight and knowledge that led to that ground-breaking invention has guided Mologic since its formation in 2003.
 
Mologic offers technology and scientific research expertise for contract research and development, alongside a portfolio of device and reagent products for clinical and commercial applications. The company also helps organizations to scale-up manufacturing from initial prototyping through low to mid-scale production. Mologic’s science has broad application across markets and disease states where rapid, accurate point-of-care testing can help make a difference in patient care and patient outcomes.
 
The company is actively seeking strategic partners for its internal pipeline of respiratory, infection, infectious disease and women’s health diagnostics.
 
Mologic is headquartered in Bedford in the United Kingdom and has a U.S. subsidiary in the greater Boston area. Mologic is backed by London-based venture capital funders Calculus Capital and Foresight Group.