Hospital facilities in Europe are being pushed to their limits as the Covid-19 pandemic continues into winter. Coronavirus testing that doesn’t require a central lab is now arriving on the scene, and it could be the solution to effectively monitor and contain the disease.
Despite the recent announcements of promising phase III data on Covid-19 vaccines, the virus causing the disease — SARS-CoV-2 — is likely to stay with us for months at the very least. Identifying infected individuals is the only way to provide proper healthcare and contain the spread.
The gold standard for detecting the virus is a technique called polymerase chain reaction (PCR), which has extremely high sensitivity. However, efficient community testing is challenging, as samples need to be collected and sent to PCR labs. Infected patients are often notified a few days after their test.
A number of diagnostics companies across Europe aim to accelerate community diagnostics by developing tests that could give results in less than an hour. The approaches employed for developing each rapid Covid-19 test differ, ranging from antibody tests and viral RNA detection to identification of living viruses. Many of these tests are performed using handheld devices that resemble a pregnancy test and require minimal expertise from the person performing the test.
One example is the Norwich-based Iceni Diagnostics, which has started producing clinical trial batches for its rapid virus detection test for both Covid-19 and influenza. These viruses could form a major health threat as they sweep the population this winter. “Covid-19 and human flu have similar symptoms. We are manufacturing a duplex test that differentiates between SARS-CoV-2 and influenza from one sample,” Berwyn Clarke, Chairman at Iceni Diagnostics, told me.
The company tests for the presence of live viruses in a sample by using sugar molecules called glycans, which the virus hooks onto when infecting cells. Such a test lets individuals make informed health decisions, knowing if they are infectious or not. “It could make the difference between UK university students being allowed home for Christmas or not,” Clarke noted.
Back in May, the FDA gave Emergency Use Authorization to Sherlock Biosciences’ CRISPR-based coronavirus detection test. The Boston-based startup uses precise sequence recognition to give easy-to-interpret results within an hour.
“When a specific sequence of DNA or RNA is present, the CRISPR enzyme is activated and, much like a pair of scissors, starts cutting nearby genetic material, releasing a fluorescent signal that indicates a positive result,” Rahul Dhanda, co-founder and CEO of Sherlock Biosciences, told me.
Since then, several companies have started developing point-of-care tests, making them cheaper and more accurate. Just this week, the Californian company Lucira got an Emergency Use Authorization for the first self-test kit anyone can use at home. Sherlock Biosciences is also working on a handheld coronavirus testing device to be used at home.
Not just wealthy countries could benefit from point-of-care Covid-19 testing. Earlier this month, the London-based LumiraDx launched a global partnership to introduce a Covid-19 test that can produce results in 12 minutes. Backed by €27M from supporters such as Bill and Melinda Gates Foundation and the Clinton Health Access Initiative, the project aims to distribute the test to African nations, including remote communities that lack specialized equipment.
OpenCell, a London-based biotech incubator, has taken a different approach to facilitating decentralized testing. The firm built PCR testing labs in shipping containers and sent them to wherever they were needed. “Our approach emphasized remote rapid response. Shipping containers are a natural solution for this, and we have been building labs in [containers] for years,” Helene Steiner, CEO of OpenCell, told me.
The container labs require a large team of skilled lab personnel to operate around the clock. “[We employ] medical laboratory assistants and biomedical scientists, alongside molecular biologists and engineering specialists for the robotics,” Steiner explained. This approach can ease some of the pressure on hospital facilities and provide high-quality lab testing in remote areas.
OpenCell has so far deployed a container in the island of Jersey, another in Pakistan, and is soon launching another facility in London. “Self-administered swab tests can be booked and tracked straight to your door, like an Uber. This will make going home for Christmas an easier experience,” Steiner added.
While companies are progressing rapidly, one of the main hurdles to implementing point-of-care testing on a massive scale is that few are fully validated for diagnosing Covid-19.
Even once testing technology is validated and in hand, effective management will still be key in stopping Covid-19. The UK’s Test and Trace system is a poignant example of how expensive testing initiatives can become mired in complexity and rushed decision-making.
Image from Elena Resko