Though PCR testing has been established as the gold standard for COVID-19 detection, it remains less accessible than rapid antigen testing, since most PCR tests typically take longer to return results and require lab equipment to do so.
A major exception to this rule comes from London-based consumer genetic testing provider DnaNudge, which produces a coronavirus PCR test that can be performed outside of a lab and takes less than two hours from sample collection to results.
The CovidNudge test received a CE mark in July 2020. Soon after, the U.K. government placed a £161 million ($222 million) order to bring 5.8 million of the tests to hospitals within the National Health Service and other nonclinical point-of-care settings, and more tests have since been deployed across Europe.
A year later, DnaNudge has its sights set on expanding well past its home borders. That expansion plan—focusing specifically on the U.S., Japan and untapped areas of Europe, according to CEO Chris Toumazou—will be helped along by new series A funding that added $60 million to the company’s coffers.
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The round was led by Ventura Capital, an investment company also based in London, and was joined by international wealth management group Bank Julius Baer. DnaNudge now plans to “dramatically speed” up its plans to make CovidNudge available around the world, Toumazou said in a statement.
Once regional regulatory clearances are locked down, the test will be distributed both via wholesale agreements with healthcare companies and medical groups and as a private, direct-to-consumer service administered by DnaNudge itself.
“The game-changing nature of our innovation has created an extraordinary commercial opportunity within next-generation medical diagnostics, and the global investor community is very excited by the transformative potential of a rapid, gold-standard RT-PCR testing platform that can screen for multiple viruses simultaneously,” said Toumazou, also the chief scientist of Imperial College London’s Institute of Biomedical Engineering.
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The CovidNudge test is meant to be administered by a trained healthcare professional. After a patient’s nasopharyngeal or cheek swab is collected, the sample is placed inside a disposable cartridge, which is in turn inserted into the portable NudgeBox testing machine.
Once inserted, the cartridge is activated, beginning the process of extracting and analyzing the sample’s DNA. The completed analysis is sent wirelessly from the NudgeBox to DnaNudge’s cloud platform, where clinicians can access the test results through the company’s Operator mobile app.
In total, the entire process takes approximately 90 minutes—far less than many other PCR COVID tests, which can take anywhere from several hours to a few days to return results to patients. Despite the shorter time period, the CovidNudge assay’s results are comparable to other PCR tests, with studies demonstrating a sensitivity rate of about 95% and specificity close to 100%.
DnaNudge’s COVID test fits neatly into its other consumer genetic testing offerings: The same DNA cartridge, which the company describes as a “lab on a chip,” can also be used to test the original sample for influenza, respiratory syncytial virus and genetic predispositions to other health conditions.