There is an urgent need for rapid and accessible testing of the novel coronavirus for an effective public health response. The current and most common method for diagnosing SARS-CoV-2 is through quantitative polymerase chain reaction (qRT-PCR), which is restricted for use within specialized laboratories. As a result, the typical turnaround time for screening and diagnosing patients with suspected SARS-CoV-2 has been more than 24 hours, a pace that is far too slow to keep up with such a contagious disease.
Mammoth Biosciences has harnessed the power of CRISPR to offer a faster, lower-cost and visual alternative to traditional qRT-PCR assays. The company’s CRISPR-based diagnostic assay, DETECTR™, can deliver results in under 45 minutes as visualized on a lateral flow strip, similar to an at-home pregnancy test. DETECTR does not require a complex laboratory setting; it can be performed with portable heat blocks and readily available, “off-the-shelf” reagents and disposable lateral flow strips. The assay offers similar levels of sensitivity and specificity to qRT-PCR tests, with 95 percent positive predictive agreement and 100 percent negative predictive agreement.
The study was led by infectious disease expert Dr. Charles Chiu, researchers from the Department of Laboratory Medicine at the University of California, San Francisco (UCSF), along with Mammoth’s Chief Technology Officer Dr. Janice Chen and Research Lead Dr. James Broughton, and the California Department of Public Health. The researchers validated the method using contrived reference samples and clinical samples from US patients, including 36 patients with COVID-19 infection and 42 patients with other viral respiratory infections.
“We need faster, more accessible and scalable diagnostics. The point-of-care testing space is ripe for disruption and CRISPR diagnostics have the potential to bring reliable testing to the most vulnerable environments.,” says Mammoth’s Chief Technology Officer Janice Chen. “Because CRISPR can be programmed to detect any DNA or RNA sequence, we have been able to reconfigure our DETECTR platform within days to detect the SARS-CoV-2 virus from one of the first confirmed cases in the U.S., made possible by our collaboration with Dr. Charles Chiu at UCSF.”
From its inception, Mammoth Biosciences has focused on leveraging the diagnostic capabilities of CRISPR to develop decentralized, point-of-care tests for a variety of diseases. Shortly after the outbreak of SARS-CoV-2 in Wuhan, China, Mammoth began building its COVID-19 diagnostic and validated the efficacy of its CRISPR-based protocols on patient samples in less than two weeks. In mid-February, Mammoth published its white paper, open-sourcing its CRISPR-based detection protocols, and in early March, published the preprint containing initial patient sample validation.