COVID-19 has taken disease tests from the laboratory – and can keep them there

Just before the COVID-19 pandemic, medical technology company Lucira Health began refining its home flu test.

“We asked ourselves in January 2020, wow, we have this platform, should we look at COVID-19?” Kelly Brezoczky, executive vice president at Lucira Health, said The edge. Most of the technology will be transferred; it was just to swap the coronavirus with the flu virus.

In November 2020, Lucira approved the first U.S. Food and Drug Administration (FDA) for a full home COVID-19 test. If the company continued to work on the flu test, Brezoczky says she is not sure if it would have been on the market by then. “Our COVID-19 product jumped our first product,” she says.

Prior to the pandemic, small companies such as Lucira and academic research laboratories worked on shrinking and speeding up tests that could diagnose someone’s viral infection by detecting genetic material of a virus in a swab from their nose or throat. They wanted to make it possible to perform these extremely accurate tests in a doctor’s office, at the patient’s or at home. But mostly, these systems were in an early stage of development. Most of this type of testing, known as molecular testing, has yet to be done in a laboratory.

The rising need for COVID-19 testing has accelerated all emerging efforts. Suddenly, the federal government and private enterprises invested millions, and the Food and Drug Administration used emergency permits to get tests on the market. Experts have long predicted that home tests could be the future, but the pandemic has shortened the timeline for getting there.

“Overall, it was a very big opportunity,” said Paul Yager, a professor in the Department of Bioengineering at the University of Washington who works on rapid test development. “It sounds cynical, but a bad problem with public health is getting everyone’s attention – and it definitely got everyone’s attention – pumping money into the field.”

Early development

A year ago, just as the COVID-19 pandemic began to accelerate in the United States, it was difficult for most people in the United States not to detect a coronavirus test. The country relied on a type of test called PCR. PCR is the gold standard approach to identifying a virus. It is looking for a fragment of the virus’ genetic material in a swab collected from a patient. That is why it is also called a molecular test: it seeks out a genetic molecule.

Molecular tests are very different from another type of virus test called an antigen test. Antigen tests look for a protein on the surface of the virus rather than the molecular code of the virus itself. It’s cheap and fast, but it can be less accurate than molecular tests like PCR.

PCR is usually a good approach: it is very accurate and easy to develop against new viruses. However, it is fine, takes training to handle the samples and requires large, energy-sucking, expensive equipment. It is usually operated in hospitals or central laboratories. It also takes a few hours to run. During an emergency in health, a few hours is too slow. And if cases and labs get an avalanche of samples, people may have to wait days to get their results.

A faster test in such situations can make a big difference in the ability of public health officials to detect infections and prevent the spread of disease. But up until the pandemic, there has been no significant investment or focus on faster, simpler molecular tests. It did not seem so necessary. ‘[Rapid testing] was more on the edge, because our normal laboratory setup in the United States was already strong, ”says Jacqueline Linnes, assistant professor of biomedical engineering at Purdue University.

Small companies and academic research laboratories were still interested in creating such systems and made significant progress with the science and technology behind them. They determined how to make gene detection energy efficient, and reduce the number of steps needed to get a result. They also worked to make it easier by people without specialized training. But they did not attract interest from large companies that could market them on a large scale, says Linnes. “It was an academic exercise.”

For example, in 2017, Yager conducted a small molecular test that could be ready for various types of diseases. But he could not get a company to work together to commercialize the product. “It was the commercial market that actually caused the project – which was technically successful – to fail,” he said. The edge last March.

From the laboratory

The pandemic reinforced the pattern. Suddenly there was funding for and commercial interest in rapid testing. The National Institutes of Health (NIH) has launched the Rapid Acceleration of Diagnostics (RADx) initiative, which funded the development of new testing technologies for COVID-19. The pandemic was an emergency for public health, and therefore the FDA cleared tests under emergency use permits (EUAs), allowing tests to be used after shorter examination periods than usual.

“We found out that the industry has all the resources and all the expertise to make these things happen – if only they had the motivation,” says Linnes.

Because researchers and small businesses were already working on rapid tests, some were able to follow the same approach as Lucira and swap their original target for the coronavirus. Visby Medical originally developed a rapid sexually transmitted infection test, but it quickly began working on a rapid COVID-19 test funded by the NIH program. It was authorized in February 2021.

Image: Visby Medical

The FDA approved the first rapid molecular tests, conducted by medical technology companies Cepheid and Abbott, in March 2020. Both can be used in health centers, nursing homes or clinics for urgent care near patients. They take a specialized machine, but samples do not have to be sent to a laboratory. Very rapid testing uses the approach: it should be done by medical professionals, but only at the place where patients are being swerved.

Visby’s test falls into that category. It has a disposable cartridge that can be used in environments such as nursing homes and some schools. Ultimately, Visby hopes its tests can be used at home, says Adam de la Zerda, founder and CEO of Visby Medical. The FDA has already cleared a handful of COVID-19 tests, including that of Lucira. Last week, the agency approved another home-molecular test from medical technology firm Cue. Unlike Lucira, Cue’s test was not prescribed.

Yager thinks there will be more pressure on home tests. “They are not all approved for home use yet, but that’s usually the direction the FDA has gone – and I think that’s a trend,” he says.

The future of diagnostics

Rapid molecular tests are still only available in extremely limited quantities. Lucira is still scaling its production lines, and Cue has not announced when its COVID-19 test could be on the shelves. But they will be more and more available next year and could usher in a new approach to disease testing in general. ‘The model today is that you go to a hospital, or stand in a long queue in a waiting room, and it takes a day. That is not the way we want to go forward, ”says Yager.

The greater interest and money for rapid molecular testing is already making a big difference for smaller businesses and academic labs. Lucira became an exchange-traded company in February and is worth more than $ 400 million. It raised a lot of eyebrows, says Yager. “The fact that there is now a game for investors is a very exciting thing.”

By moving disease tests out of the laboratory, diagnoses for diseases other than COVID-19 will be facilitated. It will also help people to start treatment early. For example, there are flu treatments that work well – but only if people start them within a day or two due to symptoms.

Normally, most people do not go to the doctor in that window, says Lucira’s Brezoczky. This is what Lucira’s flu test – which the company is still planning to launch – aims to help, she says. If people could buy an accurate test if they were going to buy cough medicine, they would know if antiviral drugs would help. “Then you actually have the chance to reduce the duration and severity of the symptoms,” she says.

Visby also hopes to get approval this year for his sexually transmitted infection test. Like flu, these types of conditions are easier to treat if caught early.

Rapid molecular tests are still expensive, says Linnes. Lucira’s COVID-19 test is $ 50. Cue has not set a price for its newly authorized home molecular test. At this stage, the price of these tests may be too high for normal cold and flu season. But ultimately, mass production and broader use can lower the price and help it become more common, Linnes says.

Apart from the price, a major benefit of the scale of rapid molecular test manufacturing would be a basis for the next public health emergency. If the tests are used regularly for common viruses, it would be easier to adapt them to test for a pandemic virus, Linnes says. The US will not be so dependent on the slower PCR in the lab.

However, this only happens if the investment and interest in these systems continues. If we return to the status quo of laboratory tests after the COVID-19 pandemic fades, and does not exploit the momentum for home tests, everyone would be in the same position as where they were a year ago. “We need to continue with the investment,” says Linnes.

The COVID-19 pandemic has shown how important it is to be able to diagnose diseases quickly and accurately, says de la Zerda. He believes there will be more focus on rapid molecular testing so that governments are prepared for new viral threats. They could have made a big difference at the beginning of this pandemic. “If we had access to these tests in high volumes, we would probably be in a very different position now,” he says. “We will certainly not be at the level of 500,000 deaths in this country.”