Sherlock Biosciences licenses Wyss Institute’s ambient nucleic acid amplification technology from Harvard to develop highly accurate, low-cost diagnostics for point-of-need

The method, integrated with highly specific CRISPR-based nucleic acid detection technology, could enable simple-to-use, portable and ultra-sensitive diagnostics for infectious disease detection in low-resource settings

By Benjamin Boettner

(BOSTON) — Today, the Wyss Institute for Biologically Inspired Engineering at Harvard University and Sherlock Biosciences Inc., announced that Sherlock has secured an exclusive world-wide license from Harvard University’s Office of Technology Development (OTD) that enables the amplification of nucleic acid molecules at ambient temperatures. The company will integrate the method, which was developed at the Wyss Institute by Founding Core Faculty member and Sherlock Biosciences co-founder James Collins, Ph.D. and his team, with its CRISPR-based SHERLOCK^TM platform to advance instrument-free diagnostic assays that can detect pathogen or disease-related nucleic acids at the point-of-need.

“Many of the diagnostic detection assays that we create in the lab for use in low-resource settings break new ground because they embody first-of-its-kind methodology that is rooted in synthetic biology,” said Collins, who co-founded Sherlock and is a member of the company’s board of directors. “While these assays are well-capable of detecting limiting amounts of target nucleic acids, their results also need to be made visible to the naked eye to be useful at the point-of-need. Our newly engineered amplification method allows one to amplify pathogen or disease-reporting nucleic acid molecules at ambient temperatures, which is an important step in this direction.”

Collins, with his group at the Wyss Institute and Massachusetts Institute of Technology (MIT), has pioneered diagnostic approaches that apply synthetic gene networks in wearable and paper-based diagnostics like, for example, a COVID-19-detecting face mask, and easily deployable and simple-to-use Ebola and Zika-detecting paper-based diagnostic tests, is also the Termeer Professor of Medical Engineering & Science at MIT.

Most nucleic acid-detecting diagnostic assays, including currently available SARS-CoV-2 PCR tests, are performed on qPCR instruments that cycle between defined temperatures. To eliminate the necessity for precise temperature cycling, biomedical researchers have developed so-called “isothermal amplification methods” that require heat to activate the amplifying enzymes, but then amplify nucleic acid sequences at a single tightly controlled temperature. The Wyss Institute’s ambient amplification method now could introduce an unprecedented robustness into molecular detection assays because it enables maximum amplification without heat-activation and in a range of temperatures, opening up various opportunities for point-of-need testing in different temperature and geographical settings.

While [many diagnostic assays that we create in the lab] are well-capable of detecting limiting amounts of target nucleic acids, their results also need to be made visible to the naked eye to be useful at the point-of-need. Our newly engineered amplification method allows one to amplify pathogen or disease-reporting nucleic acid molecules at ambient temperatures, which is an important step in this direction.

“The highly stable enzyme-based, multi-component nucleic acid amplification method coming out of Collins’ Wyss lab will be a pivotal piece of our technology platform,” said Bryan Dechairo, Ph.D., President and CEO of Sherlock Biosciences. “CRISPR-based SHERLOCK^TM technology can already be used as a diagnostic tool in virtually any setting to detect target RNA or DNA molecules with high sensitivity and specificity without strict temperature requirements. By integrating it with this next-generation amplification technology, we will be able to perform the entire detection-amplification-visualization process at ambient temperatures and, importantly, instrument-free. This unlocks vast potential for diagnostics to treat infectious disease in low resource settings, where access to diagnostics has traditionally been limited.”

Sherlock was launched in 2019 with the vision of harnessing the emerging power of CRISPR and other technologies to build low-cost, portable diagnostic tests addressing critical unmet diagnostic needs for patients at-home and in low-resource settings that lack immediate access to critical clinical infrastructure who need fast answers to control their health decisions. The SHERLOCK^TM technology was licensed to Sherlock by the Broad Institute and is co-owned by Harvard University. In 2020 the company broke ground with the first FDA-authorization for CRISPR technology for its CRISPR SARS-CoV-2 rapid diagnostic kit for the detection of the virus that causes COVID-19.

“The ambient nucleic acid amplification technology developed at the Wyss has the potential to bring CRISPR-based diagnostics into patient’s homes and low-resource settings,” said Wyss Founding Director Donald Ingber, M.D., Ph.D. “It is an excellent example of how Wyss researchers keep pushing the needle by devising disruptive technologies through their creativity, drive, and persistence.” Ingber is also the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children’s Hospital, and the Hansjörg Wyss Professor of Bioinspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.