NEW YORK – Caszyme, a Vilnius, Lithuania-based biotechnology company, has partnered with Vilnius University and NSage, a South Korean firm, to develop a CRISPR-based diagnostics platform.
The partners have formed a consortium called Universal CRISPR-based Detection Platform for Versatile and Rapid Diagnostics (UNCOVER), which commenced on April 1 and will run for the next three years. UNCOVER is supported by €300,000 ($338,000) in government funding from Lithuania, and Caszyme will contribute €180,000, according to CEO Monika Paulė. NSage, based in Incheon's Songdo International Business District, will also contribute funding.
The platform will rely on protein engineering technologies and bioinformatics from the three partners, who plan to identify new Cas proteins and optimize existing ones. Initial applications will be in infectious disease detection, in particular for SARS-CoV-2 and other respiratory infections, though Paulė said the platform could be used for a variety of pathogens and disease biomarkers in humans and animals.
The infectious disease market has been targeted by other research groups and companies with CRISPR-based diagnostics platforms, including Proof Diagnostics, Mammoth Biosciences, the Broad Institute, Harvard University, and Princeton University.
According to Paulė, infectious disease testing will be first because samples from the COVID-19 pandemic are readily available, making it an ideal use case to establish proof of concept. By the time UNCOVER runs its course in 2028, the partners hope to have a functional CRISPR-based diagnostic platform that could be outlicensed to partners who could deploy their own content on it. The technology could also be optimized for use with different kinds of devices, from more sophisticated cancer testing platforms in developed countries to simpler devices intended for less developed markets.
"We're doing the technology part," said Paulė. "If a diagnostics company wants to enter the CRISPR diagnostics field, they can license this platform and we'll adapt it to the indications they are looking for."
According to Paulė, this kind of technology development work is common for Caszyme, which she cofounded in 2017 with Virginijus Šikšnys, a professor and biochemist at Vilnius University, and Giedrius Gasiūnas, Caszyme's CSO. In 2016, Šikšnys was awarded the Warren Alpert Foundation Prize for his contribution to the understanding of the CRISPR bacterial defense system.
Two-thirds of Caszyme's team is involved in technology development. "Most of them have spent their lives in the CRISPR gene editing field," said Paulė. Given its expertise, Caszyme has sought to develop CRISPR gene editing technology "on the whole spectrum," she said, from bioinformatics through discovery, development, and validation.
Since its establishment, the company has collaborated with partners serving diverse markets including therapeutics, agriculture, and now diagnostics. Representatives of New England Biolabs, an early partner, as well as Corteva Agriscience are members of Caszyme's board.
Gintautas Tamulaitis, a research professor at Vilnius University and a consortium leader, has been involved in CRISPR-Cas research for 15 years and is listed as a co-inventor on multiple patents related to gene editing, several of them specific to Type III-A CRISPR-Cas systems.
According to Paulė, Caszyme has been in discussions with NSage since before the COVID-19 pandemic. While NSage is working on a variety of therapeutic and diagnostics applications, some unrelated to gene editing, it is interested in CRISPR diagnostics and has its own IP portfolio related to gene editing discoveries.
According to NSage CEO Bonghee Lee, one aim of the UNCOVER consortium is to develop an "ultrasensitive diagnostic kit that eliminates the need for amplification." Such a kit could give any future diagnostics partners an edge, he said.
Lee, a professor at Gachon University, founded NSage in 2016. Originally focused on induced pluripotent stem cell therapy and automated stem cell manufacturing, the company recently decided to expand its pipeline into gene editing diagnostics.
According to Lee, the company has a focus on delivering point-of-care tests to market and is looking to integrate CRISPR-Cas systems with isothermal amplification, microfluidics, and portable fluorescence detection to create such test devices.
"These tools are well suited for resource-limited settings, field testing, and decentralized diagnostics, making them versatile across clinical, agricultural, and public health applications," said Lee.
As part of UNCOVER, NSage will develop optimized detection chemistries for pathogens and help validate the resulting diagnostic workflow. The company is also seeking to accelerate the commercialization of resulting CRISPR-based diagnostics, strengthen its IP position, and establish new collaborations with academia and industry, Lee said.
All UNCOVER participants are keen to see the resulting technology adopted in East Asia, where rapid, decentralized diagnostics are in demand, Lee said, "especially in response to outbreaks and antimicrobial resistance."
Asian markets are also well positioned to embrace new point-of-care diagnostic tools, he pointed out, as governments seek to deploy such tests in regions with limited laboratory infrastructure while investing in infectious disease preparedness. While COVID-19 is fresh in everyone's memory, Asian health authorities also have to contend with rising rates of norovirus and dengue fever, as well as drug-resistant bacteria, he said. In addition, Asian markets also have "strong manufacturing and distribution ecosystems" that could make it possible to scale the deployment of future CRISPR-based diagnostics, he added.
Paulė confirmed that Asian markets would be the "initial commercial interest" for the consortium, in part because of a "more complicated" US patent landscape and more freedom to operate in Asia. Europe and the US could be future target markets, she added.