Backed by Federal Funds, New Virus Tests Are Hitting the Market
WASHINGTON — The coronavirus pandemic remained a distant threat to many Americans on Jan. 24 when Douglas C. Bryant, the president and chief executive officer of Quidel Corporation, got a call from an official at the Food and Drug Administration.
If the government helped, the official asked, would Quidel make tests to detect coronavirus infections?
Mr. Bryant decided to go for it, even though some experts at the time were predicting the United States would quickly tame any outbreak.
The gamble has paid off. Quidel, a San Diego-based maker of diagnostic tests, developed a swab-based coronavirus test that produced results from an analyzer in 15 minutes. It sold 1.2 million of them for less than $20 apiece to the federal government for use at nursing homes. A grant from the National Institutes of Health is enabling Quidel to expand its production by about 140 million tests a year, company officials said.
With the pandemic still raging as fall approaches, the government’s efforts to support development and deployment of a variety of testing methods are a rare if belated bright spot amid widespread failures to contain the virus.
In the latest round of government backing, the N.I.H. said on Wednesday that it was providing nine more companies with $123.3 million from a $2.5 billion pot of money allocated last spring by the stimulus bill to support testing. That will bring the total amount disbursed so far by the N.I.H. to $372 million across 16 companies.
The goal is to support production of a broad spectrum of tests, making them more widely available and perhaps ultimately as easy to use as a home pregnancy test. Tests must show that they meet the Food and Drug Administration’s standards for safety and accuracy before they can be sold.
“It’s going to be a wonderful competition,” Dr. Francis S. Collins, the N.I.H. director, said in an interview on Tuesday evening.
Yet even as the government helps rush new tests to market, the administration continues to issue conflicting — and sometimes flatly contradictory — messages about how many and what types of tests are needed, when they should be administered and to whom.
President Trump has long derided testing, complaining that it drives up the number of confirmed cases. The lack of a clear national strategy has confused the public, deeply frustrated public health officials and befuddled pharmaceutical executives.
But as testing options have multiplied, easing some of the shortages and laboratory bottlenecks that hampered the early response to the pandemic, universities, employers, state and local governments and other institutions have been increasingly filling in some of the vacuum left by the administration with their own testing plans.
A growing number of businesses — ranging from Soupergirl, a small company in Washington, D.C., with 30 employees that makes vegan soups, to Amazon, the world’s biggest retailer — are testing their workers.
The National Basketball Association allowed Yale University scientists access to its players for its research identifying the coronavirus in saliva samples. The Food and Drug Administration last month granted emergency use authorization for Yale’s testing method, which aimed to keep the cost to less than $10 per test. Anne Wyllie, an associate research scientist working on the project, said more than 200 laboratories had contacted Yale about it.
Among those interested is Indiana University, which is putting in place a testing program for its 120,000 students, faculty and staff. Arriving students were greeted last month with rapid-result, nasal swab tests before they could move into their dorms. Those who tested positive were either sent home or housed in an isolation dorm.
Students living off campus submitted their own saliva samples, which were then shipped to laboratories. The university is continuing to test on a targeted basis, aiming for broader screening soon, using its own laboratories. The cost is $10 million and counting.
“We figured this out ourselves,” said Dr. Aaron E. Carroll, an associate dean at the university’s medical school, who helped devise the program. Federal guidelines were of little use, he said.
Trump administration officials like Adm. Brett P. Giroir, the testing czar and an assistant secretary of health, say they want states and localities to create their own testing plans that fit their specific needs rather than to be forced to follow federal dictates. But many experts complain that the lack of federal decision-making — including how many tests a day the United States should aim for — is an impediment in the nation’s battle against the virus, which so far has killed more than 184,000 people and infected more than six million.
“Let’s not just say we are ramping up and hope we get there. Let’s have a goal in mind,” said Dr. Mark McClellan, the director of the Duke-Margolis Center for Health Policy and the commissioner of the Food and Drug Administration under former President George W. Bush. “It’s not just a matter of getting the tests to market.”
In a recent interview, Dr. Bruce J. Tromberg, who directs the N.I.H.’s test development program, estimated that the United States needed to test about six million people a day, citing reports by experts at the Rockefeller Foundation and other organizations. Without federal assistance, he said, companies would at best produce only half that number by the end of the year.
The government’s purchases of hundreds of millions of tests for nursing homes and other hot spots have helped spur development and manufacturing. The N.I.H. is trying to encourage even more production, Dr. Tromberg said, with grants that have allowed companies to build laboratories and open new manufacturing lines.
Six million daily tests “is what we are on the trajectory for,” he said.
But in a briefing last month with reporters, Admiral Giroir appeared to contradict that. “I am really tired of hearing from people who are not involved in the system that we need millions of tests every day,” he said. “We are doing the appropriate amount of testing now.”
Then, in an interview on Friday, Admiral Giroir suggested that he had misspoken. “Since Day 1, we’ve been trying to increase the number of tests,” he said.
Admiral Giroir has laid out broad principles for a national strategy: People with symptoms should be tested, and some level of surveillance — testing of large swaths of the population, regardless of symptoms — should be conducted to pinpoint outbreaks. Those can then be controlled by surges of tests, he has said.
But beyond that broad outline lies much uncertainty. To the dismay of many public health officials, for example, the Centers for Disease Control and Prevention has publicly wavered about whether people who have been in close contact with an infected person but who have no symptoms should be tested.
The Coronavirus Outbreak ›
Frequently Asked Questions
Updated September 1, 2020
Why is it safer to spend time together outside?
- Outdoor gatherings lower risk because wind disperses viral droplets, and sunlight can kill some of the virus. Open spaces prevent the virus from building up in concentrated amounts and being inhaled, which can happen when infected people exhale in a confined space for long stretches of time, said Dr. Julian W. Tang, a virologist at the University of Leicester.
What are the symptoms of coronavirus?
- In the beginning, the coronavirus seemed like it was primarily a respiratory illness — many patients had fever and chills, were weak and tired, and coughed a lot, though some people don’t show many symptoms at all. Those who seemed sickest had pneumonia or acute respiratory distress syndrome and received supplemental oxygen. By now, doctors have identified many more symptoms and syndromes. In April, the C.D.C. added to the list of early signs sore throat, fever, chills and muscle aches. Gastrointestinal upset, such as diarrhea and nausea, has also been observed. Another telltale sign of infection may be a sudden, profound diminution of one’s sense of smell and taste. Teenagers and young adults in some cases have developed painful red and purple lesions on their fingers and toes — nicknamed “Covid toe” — but few other serious symptoms.
Why does standing six feet away from others help?
- The coronavirus spreads primarily through droplets from your mouth and nose, especially when you cough or sneeze. The C.D.C., one of the organizations using that measure, bases its recommendation of six feet on the idea that most large droplets that people expel when they cough or sneeze will fall to the ground within six feet. But six feet has never been a magic number that guarantees complete protection. Sneezes, for instance, can launch droplets a lot farther than six feet, according to a recent study. It’s a rule of thumb: You should be safest standing six feet apart outside, especially when it’s windy. But keep a mask on at all times, even when you think you’re far enough apart.
I have antibodies. Am I now immune?
- As of right now, that seems likely, for at least several months. There have been frightening accounts of people suffering what seems to be a second bout of Covid-19. But experts say these patients may have a drawn-out course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may last in the body only two to three months, which may seem worrisome, but that’s perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it’s highly unlikely that it would be possible in a short window of time from initial infection or make people sicker the second time.
What are my rights if I am worried about going back to work?
The government’s $2.5 billion pot of money to develop new tests is split between the N.I.H.’s program, called Rapid Acceleration of Diagnostics, or RADx, and an agency in the Department of Health and Human Services.
One of the new tests, made by the Maryland-based company Maxim Biomedical, is what Dr. Tromberg calls a “dipstick” antigen test that relies on a nasal swab and can deliver results in 15 minutes without any additional instruments. The test has yet to receive an F.D.A. greenlight, Dr. Tromberg said, but “we’re excited.”
So far, the new tests fall short of what some experts argue is most needed: a method that is cheap and simple enough to be widely used at home, twice a week or more, regardless of symptoms. Dr. Collins said the technology for such tests, which might resemble a pregnancy test, is close at hand, but regulatory obstacles remain. No test has been authorized that can be bought over the counter and conducted entirely at home.
Some of the most attention-grabbing developments have taken place without federal grants, although the government remains a large purchaser. Abbott, a major health care company, last month won emergency approval from the Food and Drug Administration for an antigen test that is the size of a credit card, costs about $5, delivers results in 15 minutes and is intended to be given in health care settings to patients who are within a week of the onset of symptoms.
Unlike standard lab-based tests, antigen tests hunt for coronavirus proteins and can run from start to finish in settings such as a doctor’s office, urgent care clinic or pharmacy. So far, the Food and Drug Administration has granted emergency approval to about 180 lab-based tests, but fewer than 10 that can be done outside the lab.
Abbott has said it will produce 50 million tests a month by October. The federal government has agreed to buy 150 million of them, at a cost of $750 million, and will ship them to assisted living centers, nursing homes and other locations.
Together with such advances, federal officials say the government’s effort is helping to create a kind of testing smorgasbord for consumers.
One recipient of a grant from the N.I.H., a company called Fluidigm, is developing a test that collects saliva samples to be processed in laboratories. Fluidigm’s test received emergency authorization from the Food and Drug Administration last week; with the government’s funding, the company plans to expand its manufacturing capacity to more than one million tests a day by the end of March.
A Massachusetts-based firm called Ginkgo Bioworks is pioneering the use of genome sequencing to detect the coronavirus. Ginkgo used the more than $40 million it received from the N.I.H. to help construct a new laboratory that will run about 250,000 coronavirus tests a day, according to Barry Canton, a co-founder of the company. Customers will be able to purchase the test for about $25, ship their samples to Ginkgo and receive results within about 48 hours.
Some experts question whether the government’s umbrella is wide enough. Ten of the 16 N.I.H. grant recipients require test samples to be processed in a lab. Five others, while simpler and faster, still rely on expensive or cumbersome machines to yield results, making them poor candidates for widespread use.
What the N.I.H. is doing, said Dr. Syra Madad, an infectious disease epidemiologist in New York, “is a subset of what we’re looking for.”
Sharon LaFraniere reported from Washington and Katherine J. Wu from Boston. Kitty Bennett contributed research.