USA TODAY US Edition

FDA opens door to at-home tests

Cheap alternativ­e to labs would be ‘game-changer’

- Karen Weintraub

The Food and Drug Administra­tion on Wednesday opened the door to COVID-19 testing that could be fast, cheap and handled entirely at home – if companies don’t find the rules too burdensome.

Routine screening of people who don’t know they have COVID-19 could transform the fight against the disease.

“These types of tests will be a gamechange­r in our fight against COVID-19 and will be crucial as the nation looks toward reopening,” FDA Commission­er Dr. Stephen Hahn said in a statement announcing how the agency will approve at-home tests.

So far, the FDA hasn’t allowed anyone to sell tests for at-home use.

Lab tests to detect the coronaviru­s are accurate, but they’re often restricted to people who have COVID-19 symptoms. It often takes days to get results – by which point the person may have already infected others.

Other tests are fast, but they’re so expensive they’re unlikely to be used regularly. A clinic in Massachuse­tts, for example, charges $160 per rapid test; it’s not covered by insurance.

With COVID-19, people are most contagious in the few days before they develop symptoms and as symptoms first develop.

Screening at home, maybe once or twice a week, would allow people to test themselves before going to work or school, getting on an airplane, attending an event or visiting an elderly relative. Letting people know they are infectious in real-time would enable them to self-quarantine, and it would allow others to go about day-to-day life without risk of infecting others.

There could be hurdles

Several testing experts, including Dan Larremore of the University of Colorado, said the FDA’s move is a step in the right direction and could encourage companies to pursue inexpensiv­e, rapid, at-home tests.

But Dr. Michael Mina, an infectious disease epidemiolo­gist at the Harvard T.H. Chan School of Public Health, said the way the FDA’s guidance template is written makes it less likely that such crucial tests will reach the general public.

The template spells out how a sample is to be collected and analyzed and how results are to be shown to a user without the need to send a sample to a lab for analysis.

The template also outlines how accurate the tests must be, with slightly lower standards than lab-based tests.

“The (required) software alone will pose an incredibly large hurdle for many,” Mina said via email.

“Unfortunat­ely the template does not offer this type of ‘new’ avenue that I think is going to be necessary if we want to see truly $1 daily tests become a reality.”

Mina said the standards should be lowered further. People are contagious only when there’s an extremely high virus level in their body, which can be detected by a less sensitive test. An infection that goes undetected by a less-sensitive test would be caught a few days later when the person is tested again, he said. Or the person would already be on the way to recovery and probably wouldn’t be contagious.

Similar rapid tests used to diagnose strep throat miss as many as 1 in 5 people who are infected, so physicians normally send a throat culture to a lab to confirm the diagnosis, said Dr. Emily Volk, president-elect of the College of American Pathologis­ts. Such confirmato­ry testing usually takes several days.

If that were done with COVID-19, it could add to the delays of traditiona­l testing rather than relieve them.

The race is on

There are several tests close to market that are fast and relatively cheap, but none meets Mina’s vision: a rapid test that costs as little as $1 and can provide an answer before someone leaves the house in the morning.

The XPRIZE, a nonprofit that designs and hosts public competitio­ns, announced Tuesday that it would split a $5 million prize among five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15.

Another $50 million is available to scale up manufactur­ing and could be distribute­d to any contestant during the competitio­n, said Jeff Huber, president and co-founder of OpenCovidS­creen, whose company is launching the competitio­n in collaborat­ion with XPRIZE.

The competitio­n is open until the end of August. About 200 semifinali­sts will be selected. They’ll be winnowed to 20 finalists and then five winners.

Contenders will have to meet criteria that will speed up FDA approval. They’ll get expert advice from largescale testing companies, Huber said. The five winners will be ready to scale up manufactur­ing by the end of the year, he said.

Unconventi­onal options

In another approach to innovative testing, Sorrento Therapeuti­cs of San Diego has licensed technology developed at Columbia University in New York City.

Dr. Zev Williams, director of the Columbia University Fertility Center, has spent years developing tests to help couples with genetic diseases or repeat miscarriag­es have healthy babies. Early in the pandemic, Williams said his team concluded that finding the genetic signature of the virus that causes COVID-19 wasn’t all that different.

The technology the team has developed essentiall­y looks for that genetic signature in a saliva sample. The sample is put into a container with enzymes that, when heated, turn the liquid red to indicate no virus present or yellow to show an infection. The test is as accurate as the current standard, called a PCR test, which relies on expensive, lab-based machines, said Henry Ji, Sorrento’s CEO and co-founder.

The company expects the test, which has not yet received FDA approval, to cost about $10, said Mark Brunswick, the company’s senior vice president of regulatory affairs.

FDA has ‘moved the goalposts’

In a third approach, Intrivo Diagnostic­s of Santa Monica, California, and Access Bio of Somerset, New Jersey, are collaborat­ing to design and distribute a rapid at-home test. Dr. Michael Harbour, chief medical officer of Intrivo, said he expects to complete the FDA approval process in the next 90 days.

Their test provides a finger-pricking device and analyzes a drop of blood. A blue line would indicate a positive for the virus; no line would be an all-clear.

The test should be accurate enough to meet the FDA guidelines, Harbour said.

The companies are prepared to conduct trials, as required by the FDA, to make sure the test is easy enough for most people to use. He said he did not know how much it would cost.

The FDA, Harbour said, has “moved the goalposts” several times, requiring testing companies to follow one protocol and then another. But he’s hopeful it’s now clear how important this type of test will be to keep the virus under control.

“If the FDA is smart,” he said, “they are going to work quickly to make these available.”

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