Illustrations: Simone Noronha

Scientists Are Racing to Get Us Faster, Simpler Coronavirus Tests

Rapid and at-home tests could give results in minutes rather than days

DDr. John Tomaszewski has been working 16-hour days since the new coronavirus hit Buffalo, New York in mid-March. Though it’s a six-hour drive from the pandemic’s epicenter in New York City, Buffalo and the surrounding county has experienced a troubling surge in infections, racking up more than 1,700 cases and 101 deaths as of April 14.

As head of the laboratory at Kaleida Health, a nonprofit network of hospitals, Tomaszewski has been running coronavirus diagnostic tests nonstop. Even so, his efforts haven’t been nearly enough for the Buffalo-Niagara Falls metropolitan area, which is home to around 1.1 million people. With equipment donated from the University at Buffalo, where he is a professor of pathology and anatomical sciences, he has increased the number of tests his lab can run per day from 90 to about 300. He is hoping to double or triple that capacity soon, but he worries that will still fall short.

“We’re nowhere near the amount of testing you’d want to do in our region,” he says. Ideally, he’d like to be able to do at least 1,000 tests a day.

Labs across the country, much like Tomaszweski’s, not only need more tests but faster ones in order to learn the true magnitude of the pandemic. The United States can now run hundreds of thousands tests a week, but it’s still not enough to keep up with demand. In the absence of an effective vaccine or treatment, the fight against coronavirus is likely to drag on for months, and possibly into 2022.

New types of tests being developed at lightning speed could radically transform how we track Covid-19’s progression and every future disease outbreak from here on out. What has been a slow and tedious process for diagnosing infectious disease could become rapid and decentralized with new technology.

Scientists are racing to develop new coronavirus tests that could be done much faster and with less equipment. More than 300 test developers are planning to submit requests to the Food and Drug Administration to get emergency use authorization for their tests, according to FDA commissioner Dr. Stephen Hahn. Some of these tests could be as simple to use as pregnancy tests and cost less than a dollar apiece to manufacture. These advances could move testing into more emergency rooms, urgent care clinics, doctor’s offices, pharmacies, and even the homes of millions of people. Instead of waiting days or weeks for a test result, you could get one in minutes.

“If we don’t shift our thinking about diagnostic testing as a society as an outcome of all this, we will be in the exact same position when the next pandemic hits us.”

These new coronavirus tests could be here in as soon as a few weeks or months — provided that the FDA clears the way. Even then, the government and manufacturers will need to figure out how to get enough tests to everyone who needs them.

But the ongoing pandemic has exposed the flaws not only in our testing capability but in the systems we use to deploy those tests. “At the highest level, there has been a lack of national planning,” says Dr. Michael Pellini, a former diagnostics executive and a managing partner at Section 32, a technology and life sciences venture capital firm.

“If we don’t shift our thinking about diagnostic testing as a society as an outcome of all this, we will be in the exact same position when the next pandemic hits us.”

WWidespread testing for Covid-19 is crucial because it can reveal how and where the disease is spreading, what communities and populations are most at risk, and which people may now be immune. But testing shortages, faulty tests, and long processing times in the United States have made it impossible to know how pervasive the new coronavirus actually is. Rapid testing technology could help change that, if it’s rolled out in time.

The country’s coronavirus testing problems started in early February, after the Centers for Disease Control and Prevention fumbled the rollout of its diagnostic test kits. On February 5, the CDC began shipping the kits to local and state public health laboratories, which monitor emerging health threats. But when those kits arrived, many were discovered to be faulty, and those government-run labs had to wait weeks for new kits. Meanwhile, diagnostic companies, hospitals, and academic medical centers were stymied from running their own tests. They needed permission from the FDA to do so.

When the FDA finally granted that permission at the end of February, companies and labs rushed to alleviate the growing shortage.

“Without a broad population being tested, we’re never going to be able to contain any disease.”

The type of test the United States currently relies on to diagnose Covid-19 uses a long cotton swab to scrape cells deep in the nasal cavity. This sample is sent to a lab, where a technique known as polymerase chain reaction, or PCR, is used to amplify the virus’s genetic material to detectable levels. PCR is the gold standard for diagnosing infectious diseases, but it can be slow. From start to finish, a PCR test takes about six to eight hours to run. Bigger labs with high-tech equipment can use automation to run many tests at a time, but smaller labs must rely on a more manual process. Some large hospitals have these labs on-site, but often tests are sent to outside labs to be processed. With cases of Covid-19 mounting, labs everywhere are facing backlogs.

“All of a sudden you have a lot of people who need tests done at the same time,” says Dr. Brett Etchebarne, an assistant professor of emergency medicine at Michigan State University.

He’s developing a coronavirus diagnostic test that uses a mouth swab and delivers a result in five to seven minutes. The technology for rapid testing has existed for some time, but not every hospital or lab has the specialized machines to do it. But Etchebarne’s test could be performed on equipment that most hospitals already have.

In the short term, rapid tests could help relieve the backlog that laboratories are currently facing, says Etchebarne. They would also allow health care providers to test themselves and quickly find out if they are infected, instead of having to wait days on a result. When the pandemic finally wanes, the same rapid technology could also help rule out other respiratory infections like flu and help determine who needs coronavirus drugs if and when they become available.

These tests are known as “point-of-care” diagnostics because they are done in close proximity to patients, like in hospitals, urgent care centers, and emergency rooms, instead of being sent to a laboratory. One major benefit is that they are easy to perform and don’t require special training.

Two companies quickly developed rapid, point-of-care tests when the FDA gave the go-ahead for labs to do so at the end of February. One test, from Silicon Valley-based diagnostics company Cepheid, provides a result in 45 minutes using machines that vary in size and the number of samples they can hold. It can use a sample from a nasal swab or wash, the latter being a benefit with cotton swabs in short supply.

The other test, from Chicago-based Abbott Laboratories, uses a nasal swab but can deliver a positive result in five minutes and a negative result in about 13 minutes. Abbott’s test uses a machine the size of a toaster, but it can only run one test at a time. Etchebarne is designing his system so that it could run many tests at once.

To make even faster and simpler tests for Covid-19, some scientists are turning to the gene-editing technique CRISPR. Two companies on opposite coasts, San Francisco-based Mammoth Biosciences and Sherlock Biosciences in Cambridge, Massachusetts, are harnessing CRISPR’s ability to find and cut a specific sequence of genetic material in a rapid, paper-based test.

Both companies’ tests use a protein to look for the presence of SARS-CoV-2’s genetic material in a patient sample. If there’s a match, the protein binds to the genetic sequence and gives off a signal that causes a paper strip to change color. The readout takes about 30 to 45 minutes using minimal lab equipment. And the materials to make the tests are incredibly cheap. They could be produced for less than a dollar per test, says James Broughton, research lead at Mammoth Biosciences.

Such rapid tests could be used to screen people preemptively to prevent the further spread of the virus. For example, patients who come to hospitals for non-Covid-19 reasons, like scheduled surgeries or other procedures, could be screened at the door for the safety of health care workers. “I think all staff would want these preoperative diagnostics to be performed before risking going into surgery,” Etchebarne says.

Rahul Dhanda, CEO and co-founder of Sherlock Biosciences, notes that it will be important to screen people who don’t have symptoms to find carriers of the virus. “That would give you so much more information about how this disease is being spread,” he says. “Without a broad population being tested, we’re never going to be able to contain any disease.”

Broughton and Dhanda did not say when their companies’ tests will be available, but both are working to launch them soon.

Some companies want to make testing so easy you don’t even have to leave your house. Scanwell Health, a company that already makes at-home tests for urinary tract infections, is developing a Covid-19 test.

You’d get a testing kit in the mail, prick your finger to draw a tiny drop of blood, dab the blood onto a testing strip, and add a few drops of a solution. Like a pregnancy test, lines would appear on the testing strip to indicate a result. Then you’d take a picture of the result, submit it via an app, and be connected with a doctor to walk you through what the result means.

Scanwell’s Covid-19 test is meant to tell you whether you have antibodies specific to SARS-CoV-2. Antibodies are proteins that the immune system makes in response to an invading pathogen. A positive result for SARS-CoV-2 antibodies would mean that you’ve been exposed to the virus. Scientists think that harboring coronavirus antibodies could protect people from getting reinfected with the virus, at least for a time.

This kind of test isn’t good for diagnosing a current infection because it takes the body several days to start producing antibodies. Instead, it’s meant to reveal whether you’ve previously been infected with the virus, perhaps without knowing it.

AAll of these advances could greatly simplify testing and help ramp up capacity, but in order to reach a large number of people, they’ll need investment and FDA authorization. Government coordination will also be needed to make testing widely available.

Some test makers have gotten the FDA’s nod, while others haven’t. Cepheid and Abbott, whose tests were authorized at the end of March, likely got fast approval because both companies already have rapid, point-of-care tests for flu and thousands of their machines in hospitals and health care settings all over the country.

But even with the FDA’s blessing and praise from the Trump administration, Abbott’s tests aren’t getting to patients fast enough. Despite being touted by the Trump administration, the government hasn’t ordered enough of the Abbott testing cartridges for state public health labs to use.

Meanwhile, new testing systems like Etchebarne’s need to be validated to make sure they’re accurate and reliable. Then the FDA must evaluate them before they can be used to diagnose patients. And even with FDA authorization, tests developed by academic scientists often need outside investment to be commercialized if they’re to reach a wide population.

At-home tests also face hurdles. When the FDA gave certain labs permission to develop their own coronavirus tests at the end of February, a handful of companies raced to produce at-home collection kits. But after a few companies started marketing and selling those tests, the FDA issued a statement saying it has “not authorized any test that is available to purchase for testing yourself at home for COVID-19.”

Diagnostic tests that could be delivered to and performed in the home would prevent people from spreading the disease to others.

Scanwell is seeking FDA authorization for its test, but that could take weeks or months. The FDA and other medical experts are skeptical of at-home tests for many reasons. One issue is that patients might not be able to administer a test properly; another is that they may be inaccurate, as critics of at-home antibody tests in the United Kingdom have pointed out. Some worry that patients won’t know how to interpret their test results. For instance, if someone currently has Covid-19 symptoms and gets a negative result with the Scanwell test, they could wrongly assume they don’t have the disease when in reality, they might have the disease but no antibodies yet.

Dr. Shantanu Nundy, chief medical officer of health benefits company Accolade Health, says the FDA should remove some barriers to getting new at-home tests to market during a national emergency. Beyond that, he says the government needs to set up the infrastructure to get testing to the masses in an efficient way. “That infrastructure is going to make us more prepared for the next pandemic and it’s also going to make us better off every day,” Nundy says.

He says many of the concerns over at-home tests could be addressed relatively easily. For instance, YouTube videos could be used to show patients how to do a swab or pinprick correctly, or a health care provider could guide them through the process on a video call. To address the possible misinterpretation of results, patients taking at-home tests could be connected to a doctor immediately after receiving a result via an app, like the one Scanwell is proposing. At-home tests already exist for some health conditions, like flu and sexually transmitted infections. And many people with diabetes already take pinprick tests at home to monitor their blood glucose.

Tests that could be delivered to and performed in the home would prevent those who are infected with the virus from spreading it to others, and they could also help people learn whether it’s safe to go out in public or back to work without infecting anyone else.

FFor Tomaszewski, rapid testing couldn’t come soon enough. His lab in Buffalo doesn’t yet have one of the new Abbott machines. “I would like to be able to test all the people we’re worried about,” he says.

Hahn, the FDA’s commissioner, has said the agency has been “working nonstop to expedite the review and authorization of novel diagnostics” during the pandemic.

And these advancements in testing could extend beyond the current pandemic. Both Mammoth and Sherlock are working on at-home tests for other infectious diseases, and researchers at Harvard are developing a test that could tell you all the viruses that you’ve ever been exposed to.

There’s a clear need for rapid and at-home kits now, and with government investment and coordination, these types of tests could soon become a reality for millions of people. Beyond the current outbreak, having such tests available and ready to deploy in the event of a future coronavirus outbreak — or the emergence of an entirely new pathogen — could be the key to stopping it in its tracks.

Former staff writer at Medium, where I covered biotech, genetics, and Covid-19 for OneZero, Future Human, Elemental, and the Coronavirus Blog.

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