Over 170 Covid-19 diagnostic tests to date have been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA), reflecting the rapidly growing Covid-19 testing market since the initial EUA was granted in early February.

While most tests take advantage of polymerase chain reaction (PCR) technology to amplify and detect the genetic content of the SARS-CoV-2 virus, the remarkable biotechnology of CRISPR has also demonstrated success in quickly and accurately diagnosing Covid-19 patients. With the recent EUA approvals for CRISPR-based point-of-care (POC) tests for Covid-19 diagnosis, CRISPR biotechnology now has the chance to establish itself as a potential disruptor of the Covid-19 diagnostic testing market.

CRISPR is a well-known biotechnological tool for gene editing due to its programmable ability to detect specific sequences of DNA within a gene of interest and subsequently ‘snipping’ it, using an enzyme effectively functioning as molecular scissors. By removing the latter enzyme, however, CRISPR can operate as a diagnostic tool for detecting specific sequences of DNA such as those that uniquely exist in the SARS-CoV-2 virus. Two startup companies have capitalised on this capability by developing their own CRISPR-based POC tests, specifically for rapid Covid-19 diagnosis.

Sherlock Biosciences with its Sherlock CRISPR SARS-CoV-2 kit is the first company that received a EUA for a CRISPR-based POC test. As the kit can diagnose Covid-19 patients in 20 minutes, it has become an attractive option for widespread use compared to many of its non-CRISPR-based counterparts. Importantly, the Sherlock kit also represents the very first clinical use of CRISPR as every application of the technology for the past decade has been restricted within research settings. Sherlock Biosciences has also recently partnered with Binx Health to scale its testing and reduce the testing time as the latter company has experience developing its binx io, an FDA-approved rapid POC testing system for sexually transmitted infections.

The second and more recent EUA granted to a CRISPR-based POC test was to the SARS-CoV-2 RNA DETECTR Assay developed by Mammoth Biosciences. The startup, co-founded by Dr Jennifer Doudna (widely regarded as the co-inventor of CRISPR gene-editing technology), has also partnered with GSK Consumer Healthcare to receive consumer insights and commercial expertise for its successful product development. While the CRISPR-based molecular diagnostic market currently comprises just these two companies, GlobalData expects more will emerge within the next few years as the diagnostic potential of CRISPR for Covid-19 (among other infections and diseases) will be increasingly recognised.

With the recent resurgence of Covid-19 cases across the US, and an impending second wave across the world likely within the next year, the demand for more rapid, widely available diagnostic kits will continue to grow. GlobalData expects the increased use of CRISPR-based POC testing kits to be a starting point for the CRISPR biotechnology to disrupt the Covid-19 testing market and other diagnostic tests in the future.

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