The Food and Drug Administration said Saturday that it will allow hundreds of academic hospital labs in the U.S. to immediately begin testing for the novel coronavirus, a move that comes after testing designed by public health officials to identify cases of COVID-19 was subjected to a botched rollout and inaccurate readings.
The action creates the opportunity virtually overnight to test thousands of patients rather than the few hundred tested so far, the agency said.
“We believe this policy strikes the right balance during this public-health emergency,” FDA Commissioner Stephen Hahn said in a statement.
“We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations,” he said.
A woman in her 50s, who was considered medically at risk, according to state officials and repeated by President Trump in a Saturday press conference, has died of COVID-19 in the state of Washington. Hers is the first reported U.S. death from this cause. Already, health officials in California, Oregon and Washington state worried about the novel coronavirus spreading through West Coast communities after confirming three patients were infected by unknown means. Officials said the Washington death was not linked to travel.
The identification of these cases of community transmission of the novel coronavirus had put additional pressure on the Centers for Disease Control and Prevention (CDC) to improve the distribution and validation of the tests and ensure that the right people are being tested.
“Sooner, rather than later, we may be testing a lot more people,” said Andy Pekosz, a professor of molecular microbiology and immunology at the Johns Hopkins University Bloomberg School of Public Health, before the FDA announcement. “This is the next sign we will have to expand testing in the future.”
The coronavirus was first detected in December in Wuhan, China. Since then, it has sickened more than 83,000 people and killed at least 2,867 people worldwide. The majority of cases and deaths have taken place in China; however, a sharp uptick in the number of cases and deaths being reported in Iran, Italy and South Korea over the last week has panicked markets and pushed the topic front of mind for many Americans.
That, in turn, has raised questions about U.S. preparedness for the potential community spread of the virus, including the nation’s ability to accurately and quickly test people for both diagnosis and surveillance purposes. According to the CDC, the U.S. has tested 459 people for COVID-19. In comparison, Guangdong, China, has tested 320,000 samples, and South Korea has tested more than 66,000 people.
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“We do not know how many people are infected in the United States because we are not really testing,” said Raymond James analysts, who noted that Hawaii tried to have samples from its residents tested in Japan because of the testing bottleneck in the U.S.
There have been multiple issues with the test, in addition to questions about the testing protocol. As of Monday, only 12 public health laboratories were able to perform the test. (All states are now expected to have test kits by the end of next week, CDC said Friday.) The test, which has three components, had a faulty third component that made the results show up as inconclusive. The agency then decided to allow public health labs to conduct the first two components of the test but would require final confirmation from the CDC, a move that adds 48 hours to the testing process.
“I am frustrated like I know many of you are that we have had issues with our test,” Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters this week.
That additional step has prompted criticism from New York City Mayor Bill de Blasio. “Right now the CDC posture is they are letting perfect be the enemy of good,” he said during a news conference. “We believe that if they would empower local laboratories, we could work with them to do high quality testing faster. That will allow us to keep staying ahead of the situation. We want to be their partners, but we need more flexibility.”
The agency also didn’t widen the testing criteria to include travelers from countries with documented cases of community spread of the virus, including Iran, Italy, South Korea and Taiwan, among others, until Thursday night. The previous criteria only tested people who had traveled to mainland China or had come in close contact with someone who had been diagnosed with the virus.. California, which has 28 cases of the novel coronavirus, including the first possible case of person-to-person transmission in the community, is monitoring more than 8,400 people who have returned to the state from China. It only had 200 test kits on Thursday, Gov. Gavin Newsom said Thursday.
“The real inadequacy is not just the lack of test kits, it was lack of ability to use those test kits,” he said. “Now we’ll be able to use them, and we will be the recipient of an exponential increase in new test kits and then more testing locations will be made available. So we don’t have to send everything back to CDC headquarters in one testing location. We’ll see multiples of locations over the course of the next few months.”
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The latest case in California has particularly worried states, given that the woman had not traveled to Asia or had any known contact with someone with COVID-19 and may indicate that the virus will be more likely to spread in the U.S. The UC Davis Medical Center, which is treating the patient, said it took the CDC five days to agree to test her for COVID-19. “Since the patient didn’t fit the existing CDC criteria for COVID-19, a test was not immediately administered,” the Sacramento-based hospital said in a statement. “UC Davis Health does not control the testing process.”
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The CDC on Friday disputed that explanation, saying it didn’t receive a phone call until Feb. 23.
Much of the Trump administration’s early focus on addressing the outbreak was on containment, including banning entry to the U.S. by foreign nationals traveling from China and putting thousands of Americans who had been repatriated from Wuhan, China, the epicenter of the outbreak, and the Diamond Princess cruise ship in 14-day quarantines.
For this particular virus, the test is considered an important public health tool because it can help identify people who have mild cases of COVID-19 who may still be spreading the virus to more vulnerable populations, much like the flu, Pekosz said. Identifying the mild cases and either treating them or isolating them can help break the “chain of transmission” of the virus, he added. With other coronaviruses, like severe acute respiratory syndrome (SARS), people who had the virus had severe systems, making it easier to identify who should be quarantined.
Once the test receives FDA approval, that will open up the market to commercial labs to step up and make their own versions of the test. A number of companies are already developing COVID-19 tests, including Co-Diagnostics CODX, -17.11% which this week received a CE mark in the European Union for its COVID-19 test. Maxim Group analyst Jason McCarthy writing in a note that the company’s test has “greater ease of use” than the CDC test.
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