The US defence department’s research arm is developing three new coronavirus tests that aim to diagnose the disease at an earlier stage and with greater accuracy than has so far been possible.
The move comes after criticism of the US response to the coronavirus threat, where experts fear a shortage of testing equipment and its inaccuracy has allowed the disease to spread undetected across much of the country.
“We have this diagnostic problem right now in America — we are challenged with not having enough tests and we don’t have the ability to detect the virus in people early enough,” Eric Van Gieson, a biomedical engineer at the Defense Advanced Research Projects Agency (Darpa), a research arm of the US Department of Defense, told the Financial Times.
He said published research indicated current tests could detect the virus only once the illness was quite developed, at around day five.
The defence department’s cutting-edge research relies on samples given by 14 US patients who were evacuated by plane from China and by cruise ship from Japan and transferred to America’s largest national bio-containment unit in Nebraska for treatment.
“We are weeks behind in understanding the number of cases and the transmission of the infection domestically,” said Jana Broadhurst, medical director for Nebraska’s bio-containment unit clinical lab and an infectious diseases diagnostics specialist at the University of Nebraska Medical Center. She said the US had performed far fewer tests over past weeks than its global counterparts. “We’re going to need testing available for many months to come.”
Dr Broadhurst said her team had developed a highly accurate pathogen test that detected a different segment of the virus genome from current tests to allow highly accurate, scalable detection of the coronavirus.
Mr Van Gieson said it could be available for mass production within a month, at 100,000 tests a day for distribution to thousands of clinical labs all over the US that do not have access to test kits produced by the Centers for Disease Control and Prevention.
CDC, the federal health protection agency, has faced criticism for not producing enough coronavirus tests of sufficient quality. A new batch of CDC serological tests will only be able to detect the disease at least 21 days after the onset of symptoms.
Roche, a Swiss diagnostics company, said on Friday it had won emergency-use approval from the US Food and Drug Administration for commercial distribution of its high-volume coronavirus tests to clinical labs across the US, adding that it would make millions of extra tests available each month.
The second Darpa test will focus on epigenetics — looking for signs that the body is responding to the disease rather than the presence of the pathogen itself — to permit earlier detection through blood testing. Epigenetic diagnosis, which is available for cancer and arsenic poisoning, has never before been applied to an infectious disease.
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Mr Van Gieson said the breakthrough research would focus on identifying tags unique to Covid-19 left on the DNA of cells that respond to infection and could theoretically show a response “within one or two days”.
“We think we could get it into mass production within a month or two if we pass regulatory approval,” he said, adding that the effort would be tested head-to-head against conventional pathogen diagnosis to assess performance.
The third test would rely on gene editing, or Crispr technology, sending an enzyme to “cut” a genetic segment of the pathogen that can test thousands of samples at the same time.
The team is also seeking to develop tests as simple and cheap as a pregnancy test, to give results in a few minutes. The CDC tests take hours to run and require skilled laboratory technicians, which limits the numbers of clinics that can run the test.
“We can get incredible genetic specificity,” said Renee Wegrzyn, the Darpa biotechnologist who runs the gene-editing test programme, adding that it would probably be more sensitive than current solutions and require smaller patient samples.
She said the science could be developed by late summer and a separate four-year programme would seek to produce one-step tests for less than $1 and $10 tests that could analyse thousands of samples at a time.
Neither Darpa nor the Nebraska scientists would take charge of mass production of the tests but Mr Van Gieson said Darpa had made “the whole of government aware of the programmes that we’re developing” and would be ready to find a manufacturing solution if the research is conclusive.
Dr Broadhurst said good testing was not only “critical” to ascertaining the extent of the introduction and spread of the infection in a new community, but was also essential to protect frontline medical staff, determine when to move a patient out of isolation and for further research into the new disease.
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