COVID-19 did disease tests outside the lab – and can keep them there

Just before the COVID-19 pandemic hit, medical technology company Lucira Health was beginning to adjust its home flu test.

“In January 2020, we asked ourselves: wow, we have this platform, should we look at COVID-19?” Kelly Brezoczky, executive vice president of Lucira Health, said The Verge. Most of the technology would be transferred; it was just a matter of exchanging the coronavirus for the flu virus.

In November 2020, Lucira obtained the first authorization from the U.S. Food and Drug Administration (FDA) for a fully homemade COVID-19 test. If the company had continued to work on its flu test, Brezoczky says he is not sure if he would be on the market by then. “Our COVID-19 product has surpassed our first product,” she says.

Before the pandemic, small companies like Lucira and academic research labs worked to reduce and accelerate tests that could diagnose someone’s viral infection by detecting the genetic material of a virus on a nose or throat swab. They wanted to make it possible for these highly accurate tests to be done in a doctor’s office, beside the patient’s bed or at home. But, for the most part, these systems were in the early stages of development. Most of this type of test, known as molecular testing, still needed to be done in a laboratory.

The growing need for COVID-19 tests has accelerated all these nascent efforts. Suddenly, the federal government and private companies were investing millions, and the Food and Drug Administration was using emergency authorizations to place tests on the market. Experts have long predicted that home testing could be the future, but the pandemic has shortened the time to get there.

“Overall, it was a great opportunity,” says Paul Yager, a professor in the bioengineering department at the University of Washington who works on developing rapid tests. “It sounds cynical, but a bad public health problem that catches everyone’s attention – and it certainly caught everyone’s attention – injects money into the field.”

Early development

A year ago, when the COVID-19 pandemic was beginning to accelerate in the United States, it was difficult, if not impossible, for most people in the United States to screen for a coronavirus test. The country had a type of test called PCR. PCR is the gold standard approach to identifying a virus. He looks for a fragment of the virus’s genetic material on a cotton swab collected from a patient. That is why it is also called a molecular test: it researches a genetic molecule.

Molecular tests are very different from another type of viral 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. They are cheap and fast, but they can be less accurate than molecular tests like PCR.

PCR is usually a good approach: it is extremely accurate and easy to develop against new viruses. However, it is meticulous, requires training to handle the samples and requires expensive equipment that sucks energy. It is usually performed in hospitals or centralized laboratories. It also takes a few hours to run. During a health emergency, some hours are very slow. And when cases increase and laboratories receive a flood of samples, people may have to wait days to get the results.

A faster test in these situations can make a big difference in the ability of public health officials to track infections and prevent the spread of disease. But until the pandemic arrived, there was no significant investment or focus on creating faster and simpler molecular tests. It didn’t seem so necessary. “[Rapid testing] it was more on the sidelines, because our normal laboratory setup in the United States was already robust, ”says Jacqueline Linnes, assistant professor of biomedical engineering at Purdue University.

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

Yager, for example, had a small molecular test that could be applied to various types of diseases ready in 2017. But he couldn’t get a company to work with him to market the product. “It was the commercial market that really caused the project to fail – which was technically successful,” he said. The Verge last march.

Outside the lab

The pandemic has changed this pattern. Suddenly, there was funding and commercial interest in the rapid tests. The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative, which financed the development of new test technologies for COVID-19. The pandemic was a public health emergency, so the FDA released the tests under Emergency Use Authorizations (EUAs), which allow the tests to be used after shorter than normal examination periods.

“We found that the industry has all the resources and all the know-how to make this happen – if only they had the motivation,” says Linnes.

As the researchers and small startups were already working on rapid tests, some were able to take the same approach as Lucira and exchange their original target for the coronavirus. Visby Medical had originally developed a rapid sexually transmitted infection test, but quickly began work on a rapid COVID-19 test that was funded by the NIH program. It obtained authorization in February 2021.

Image: Visby Medical

The FDA authorized the first rapid molecular tests, carried out by medical technology companies Cepheid and Abbott, in March 2020. Both can be used in health centers, nursing homes or emergency care clinics close to patients. They take a specialized machine, but the samples do not need to be sent to a laboratory. Many rapid tests use this approach: they must be done by medical professionals, but right where patients are rubbed.

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

Yager believes there will be more pressure for testing at home. “They have not yet been approved for home use, but that is usually the direction the FDA has taken – and I think it is a trend,” he says.

The future of diagnostics

Rapid molecular tests are still only available in extremely limited quantities. Lucira is still scaling his production lines and Cue has not announced when his COVID-19 test may be on the shelves. But they will be increasingly available in the coming year and may usher in a new approach to testing for disease in general. “Today, the model is for you to drag yourself to a hospital or stand in a long line in a waiting room and it takes a day. This is not how we want to move forward, ”says Yager.

The increase in interest and money in rapid molecular testing is already making a huge difference for smaller companies and academic laboratories. Lucira became a publicly traded company in February and is worth more than $ 400 million. This raised a lot of eyebrows, says Yager. “The fact that there is now a game for investors to join is a very exciting thing.”

Taking the disease test out of the lab would make the diagnosis of diseases other than COVID-19 easier. It would also help people to start treatment early. There are flu treatments, for example, that work well – but only if people start them a day or two after experiencing symptoms.

Usually, most people don’t go to the doctor at that window, says Brezoczky de Lucira. That’s what Lucira’s flu test – which the company still plans to launch – was intended to help, she says. If people could buy an accurate test when they went out to buy cough medicine, they would be able to know if antivirals would help. “So, you really have a chance to reduce the duration and severity of the symptoms,” she says.

Visby also hopes to get clearance for his sexually transmitted infection test this year. Like the flu, these types of diseases are easier to treat if they are detected early.

Rapid molecular tests are still expensive, says Linnes. Lucira’s COVID-19 test costs $ 50. Cue has not set a price for its newly authorized home molecular test. At this point, the price of these tests can be very high for regular use in the cold and flu season. But eventually, mass production and broader use can lower the price and help them become more common, says Linnes.

In addition to the price, a major advantage of expanding the manufacture of rapid molecular tests would be to build a foundation for the next public health emergency. If tests were used regularly for more common viruses, it would be easier to adjust them to test for a pandemic virus, says Linnes. The United States would not rely so much on the slowest PCR in the laboratory.

This only happens, however, if the investment and interest in these systems continues. Returning to the status quo of laboratory tests after the disappearance of the pandemic COVID-19, and not taking advantage of the momentum for home tests, would leave everyone in the same position they were in a year ago. “We need to continue 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 in the beginning of the pandemic. “If we had access to these tests in large volumes, we would probably be in a very different position now,” he says. “We certainly wouldn’t be at the level of 500,000 deaths in this country.”