Backed by Federal Funds, New Virus Checks Are Hitting the Market

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Backed by Federal Funds, New Virus Tests Are Hitting the Market

WASHINGTON – The coronavirus pandemic remained a distant threat to many Americans on January 24th when Douglas C. Bryant, president and chief executive officer of Quidel Corporation, received a call from an official in the Food and Drug Administration.

If the government helped, the official asked, would Quidel run tests to detect coronavirus infections?

Mr. Bryant opted for it, although some experts at the time predicted the United States would quickly tame any outbreak.

Gambling has paid off. Quidel, a San Diego-based diagnostic test manufacturer, developed a swab-based coronavirus test that gave results from an analyzer in 15 minutes. It sold 1.2 million of these for less than $ 20 apiece to the federal government for use in nursing homes. A grant from the National Institutes of Health enables Quidel to add approximately 140 million tests per year to its production.

With the fall pandemic still raging, the government's efforts to support the development and use of a variety of testing methods are a rare, if belated, bright spot in the face of widespread failures in containing the virus.

In the last round of government support, the N.I.H. On Wednesday, the company announced that nine other companies have raised $ 123.3 million from a $ 2.5 billion pot of funds made available through the stimulus package last spring to support testing. This brings the total amount previously paid by the N.I.H. to $ 372 million across 16 companies.

The aim is to help create a wide variety of tests so that they are more widely available and, ultimately, as easy to use as a home pregnancy test. Tests must show 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," said Dr. Francis S. Collins, the N.I.H. Director said in an interview on Tuesday night.

But even as the government helps bring new tests to market, the administration continues to issue conflicting – and sometimes completely conflicting – reports about how many and what types of tests are needed, when and to whom they should be done.

President Trump has long mocked tests and complained that the number of confirmed cases is increasing. The lack of a clear national strategy has puzzled the public, deeply frustrated public health officials and confused pharmaceutical executives.

However, as testing options have multiplied and some of the bottlenecks and laboratory bottlenecks that hampered early response to the pandemic have been eased, universities, employers, state and local governments and other institutions have increasingly filled some of the vacuum left by administration with theirs own test plans.

A growing number of companies – from Soupergirl, a small Washington, DC company with 30 employees that make vegan soups, to Amazon, the world's largest retailer – are testing their employees.

The National Basketball Association gave Yale University scientists access to their players to identify the coronavirus in saliva samples. The Food and Drug Administration granted emergency approval for Yale's testing method last month, which was designed to reduce costs to less than $ 10 per test. Anne Wyllie, an associate scientist working on the project, said more than 200 laboratories contacted Yale about it.

Among those interested is Indiana University, which is establishing a testing program for its 120,000 students, faculties, and staff. Incoming students were greeted with quick nasal swab tests last month before they could move into their dormitories. Those who tested positive were either sent home or placed in an isolation home.

Students living off campus submitted their own saliva samples, which were then sent to laboratories. The university continues to carry out targeted tests and is soon aiming for broader screening with its own laboratories. The cost is $ 10 million.

"We figured that out ourselves," said Dr. Aaron E. Carroll, Associate Dean of the university's medical school, who helped develop the program. Federal guidelines have been of little use, he said.

Trump administration officials such as Adm. Brett P. Giroir, the test tsar and assistant health minister, say they want states and communities to create their own test plans to suit their specific needs rather than being forced to follow federal regulations. However, many experts complain that the lack of federal decisions – including the number of tests per day that the United States should seek – is creating an obstacle to the nation's fight against the virus, which has killed and more than infected more than 184,000 people to date has six million.

"Let's not just say we go up and hope we get there. Let's have a goal in mind," said Dr. Mark McClellan, director of the Duke Margolis Center for Health Policy and commissioner of the Food and Drug Administration below Former President George W. Bush, "It's not just about getting the tests on the market."

In a recent interview, Dr. Bruce J. Tromberg, head of the test development program at N.I.H., stated that the US must test approximately six million people every day, and cited reports from experts at the Rockefeller Foundation and other organizations. Without federal support, companies would at best only produce half of this figure by the end of the year.

The government's purchase of hundreds of millions of tests for nursing homes and other trouble spots has spurred development and manufacture. The N.I.H. tries to encourage even more production, said Dr. Tromberg with grants that have enabled companies to build laboratories and open new production lines.

Six million daily tests "is what we are on the way for," he said.

But in a briefing with reporters last month, Admiral Giroir appeared to disagree. "I'm really tired of hearing from people who are not on the system that we need millions of tests every day," he said. "We are now doing the appropriate amount of tests."

Then Admiral Giroir suggested in an interview on Friday that he had spoken wrongly. "We have been trying to increase the number of tests since day 1," he said.

Admiral Giroir has established broad principles for a national strategy: people with symptoms should be tested, and some level of surveillance – testing large segments of the population, regardless of symptoms – should be done to locate outbreaks. These can then be checked through a series of tests, he said.

But beyond these broad lines there is a lot of uncertainty. To the horror of many public health officials, for example, the Centers for Disease Control and Prevention has publicly hesitated over whether to test people who have been in close contact with an infected person but have no symptoms.

The coronavirus outbreak>

frequently asked Questions

Updated September 1, 2020

  • Why is it safer to hang out together outside?

    • Outdoor gatherings reduce the risk as the wind spreads viral droplets and sunlight can kill some of the virus. Open spaces prevent the virus from building up and being inhaled in concentrated quantities. This can happen when infected people exhale in a confined space for long periods of time, said Dr. Julian W. Tang, virologist at the University of Leicester.
  • What are the symptoms of the coronavirus?

    • In the beginning, the coronavirus appeared to be primarily a respiratory illness – many patients had a fever and chills, were weak and tired, and coughed a lot, although some people don't show many symptoms at all. Those who seemed the sickest had pneumonia or acute respiratory distress syndrome and were given supplemental oxygen. By now, doctors have identified many more symptoms and syndromes. In April the C.D.C. added to list of early signs of sore throat, fever, chills, and muscle pain. Gastrointestinal disorders such as diarrhea and nausea have also been observed. Another tell-tale sign of infection can be a sudden, profound decrease in your sense of smell and taste. In some cases, teenagers and young adults have developed painful red and purple lesions on their fingers and toes – nicknamed "covid toe" – but few other serious symptoms.
  • Why does it help to stand three feet away from others?

    • The coronavirus spreads mainly through droplets from your mouth and nose, especially when you cough or sneeze. The C.D.C., one of the organizations using this measure, bases its six-foot recommendation on the idea that most of the large droplets that people make when they cough or sneeze fall within six feet of the ground. But six feet has never been a magical number that guarantees complete protection. For example, sneezing, according to a recent study, can trigger droplets that are far farther than two meters away. It's a rule of thumb: it is best to stand six feet apart, especially when it's windy. But always wear a mask even if you think they are far enough apart.
  • I have antibodies. Am i immune now?

    • As of now, this seems likely for at least a few months. There have been terrifying reports of people appearing to be suffering from a second attack of Covid-19. However, experts say these patients may have a lengthy 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 only last in the body for two to three months, which may seem worrying, 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 is highly unlikely to be possible in a short window of time after the initial infection or make people sick the second time.
  • What are my rights if I am worried about going back to work?

The government's $ 2.5 billion pot for new test development will be split between the N.I.H. program, Rapid Acceleration of Diagnostics [RADx], and an agency in the Department of Health and Human Services.

One of the new tests from Maryland-based Maxim Biomedical is a Dr. Tromberg called “test strips” antigen test, which is based on a nasal swab and can provide results in 15 minutes without additional instruments. The test does not yet have an F.D.A. green light said Dr. Tromberg, but "we're excited."

So far, the new tests don't meet the requirements of some experts: a method that is cheap and simple enough to be used at home twice a week or more, regardless of symptoms. Dr. Collins said the technology for such tests, which might be similar to a pregnancy test, is at hand, but regulatory obstacles remain. No test has been approved that can be bought over the counter and done entirely at home.

Some of the most eye-catching developments came without federal funding, although the government is still a big taker. Abbott, a major healthcare company, last month received emergency approval from the Food and Drug Administration for an antigen test that is the size of a credit card, costs about $ 5, provides results in 15 minutes, and is supposed to be administered in healthcare settings Patients who are within a week of the onset of symptoms.

Unlike standard laboratory tests, antigen tests look for coronavirus proteins and can be done from start to finish in settings like a doctor's office, emergency clinic, or pharmacy. To date, the Food and Drug Administration has issued an emergency permit for about 180 laboratory tests, but fewer than 10 that can be performed outside the laboratory.

Abbott has announced that it will produce 50 million tests per month through October. The federal government has agreed to buy 150 million of these for $ 750 million and ship them to assisted living centers, nursing homes and other locations.

Along with such advances, federal officials say government efforts are helping to create some kind of test smorgasbord for consumers.

A grant recipient from N.I.H., a company called Fluidigm, is developing a test that collects saliva samples for laboratory processing. The Fluidigm test was approved by the Food and Drug Administration in an emergency last week. With government funding, the company plans to expand its production capacity to more than a million tests per day by the end of March.

A Massachusetts-based company 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. A new laboratory is to be built that will run around 250,000 coronavirus tests every day, according to Barry Canton, a co-founder of the company. Customers can purchase the test for approximately $ 25, send their samples to Ginkgo, and receive the results within approximately 48 hours.

Some experts ask whether the government roof is wide enough. Ten of the 16 N.I.H. Scholarship holders need test samples that need to be processed in a laboratory. Five others, while simpler and faster, rely on expensive or cumbersome machinery to get results, making them poor candidates for widespread use.

What about the N.I.H. 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 to the research.

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