CAMBRIDGE, Mass. & BEDFORDSHIRE, U.K.—New options for point-of-care diagnostic testing are the name of the game for a recently announced collaboration between Sherlock Biosciences and Mologic Ltd. With the aid of the Bill & Melinda Gates Foundation—thanks to the expansion of an existing grant to Mologic—Sherlock Biosciences and Mologic will combine their core synthetic biology platform and advanced lateral flow expertise, respectively, for the development of sophisticated molecular diagnostics for point-of-need testing in patients’ homes and in low-resource areas. In addition, Mologic will expand its footprint in Cambridge thanks to a joint development center to be built in Sherlock’s laboratory space. Financial details for this agreement were not released.
“We believe there is a unique and 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, CEO and co-founder of Mologic. “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’s key technology, the INSPECTR (Internal Splint-Pairing Expression Cassette Translation Reaction) platform, is a synthetic biology approach that uses cell-free systems as programmable molecular diagnostic devices, which results in instrument-free diagnostic tests with utility across a variety of diseases.
For its part, Mologic has developed ELTABA (Enzymatic Ligand Transformation Affinity Binding Assay), an enzymatic activity platform that provides users with highly specific, sensitive measurement of enzymes. Substrate cleavage sites are detected with a specific antibody that is captured and developed in a traditional lateral flow immunoassay format.
The hope is to combine the functions of these technologies to develop affordable, universal diagnostic platforms that can detect DNA or RNA targets at any point of need.
“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,” noted 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.”
In other recent point-of-care news from Mologic, the company announced in late November that it had initiated a clinical trial to validate Headstart, its in-vitro urine-based multi-biomarker self-test, for diagnosing exacerbations in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The COPE-WEL trial will recruit 263 patients across 10 sites in the United Kingdom. Joining Mologic are Prof. Chris Brightling, National Institute for Health Research (NIHR) Senior Research Fellow and Clinical Professor in Respiratory Medicine at the University of Leicester, who is leading the study at the NIHR Leicester Biomedical Research Centre; Prof. Keir Lewis, chair in Respiratory Medicine at Swansea University and R&D director at Hywel Dda University Health Board; and another study leader.
Headstart detects five biomarkers that point to infection and inflammation in COPD patients. In a proof-of-concept study, the test proved capable of predicting the onset of a COPD exacerbation up to six days before symptoms emerged, or up to nine days before a clinical diagnosis. In the newly announced COPE-WEL study, participants will conduct daily urine testing to establish their baseline biomarker profile, then monitor those biomarkers over the course of six months.
“COPD is now the third most common cause of death worldwide. Sufferers experience daily breathlessness and recurrent lung attacks often needing admission to hospital,” noted Lewis. “Headstart is based on a urine test and applies state-of-the-art biomarker measurement with app technology to place a simple kit in the patient’s home. This puts the patient at the heart of their care, and we hope early warning of worsening COPD could stop attacks before they take hold. I am delighted to be continuing work with Mologic on this groundbreaking project, as I believe Headstart offers a fabulous opportunity to impact this devastating illness.”