In an effort to get tests for the new coronavirus to the public more quickly, the U.S. Food and Drug Administration is waiving the normal regulations and allowing test makers to market scientifically valid products in the U.S. immediately.
FDA waives regulations to get more COVID-19 tests on U.S. market
Test makers will need to ensure that tests work and include disclaimers that the tests aren't definitive.
March 17, 2020 at 11:54PM
The FDA announced updated federal guidelines Monday night — which it called "unprecedented" — to allow new point-of-care and laboratory diagnostic tests for the new virus to go onto the U.S. market. The guidelines say test makers need to independently ensure that the tests work and include disclaimers noting the test is not definitive and has not been reviewed by the FDA.
"This action demonstrates the FDA's ability to pivot and adapt as the situation warrants in light of a public health emergency. We are taking steps to support diagnostic development considering the urgent need," the FDA said Monday night.
A Salt Lake City company called Co-Diagnostics said Tuesday morning that it intends to quickly distribute its Logix Smart COVID-19 test to certified labs around the country.
"As a result of the change announced last night by the FDA, the company's test kit will soon be available for use by and marketed to a wide array of U.S. laboratories, without first requiring Emergency Use Authorization," Co-Diagnostics said in a statement Tuesday morning.
In the U.S., all tests being performed to detect the new virus work by detecting snippets of viral genetic code in a patient sample. They require large, complex machines run in central laboratories, in places such as state health departments, major hospitals and commercial labs.
On Monday night, the FDA issued guidance stating that it does not intend to object if companies start offering "serology" tests, which can infer the presence of the new coronavirus by detecting specific blood cells produced in response to the virus.
"We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis," the FDA statement says. Serology devices should include a disclaimer noting that "results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status."
SARS-CoV-2 is another name for the novel coronavirus that causes the illness dubbed COVID-19 by the World Health Organization. As of Tuesday, 183,000 people worldwide have tested positive for the virus, including 4,661 in the United States. More than 50 Minnesotans have been diagnosed with COVID-19, and several have been hospitalized for it.
The growing impact of public health measures to slow the spread of the virus — including canceling elective surgeries and discouraging St. Patrick's Day parties — has generated strong interest in quickly identifying and quarantining those who can spread the virus.
But testing Americans for the new coronavirus has been challenging. Initially, there were issues with distributing enough tests and related supplies to certified labs around the country. Since then, more labs have stepped forward to help fill the gap, and the FDA's guidance on Monday allows states, instead of federal officials, to regulate certified laboratories.
The existing tests can still take hours or days to produce results, however, and they may produce a false-negative test if the virus hasn't generated enough genetic material to be detected through the widely used technique called RT-PCR, or "reverse transcription polymerase chain reaction."
Serology tests look at the number of antibodies and proteins in the blood to infer a biological response to the virus.
Divyaa Ravishankar. global product marketing manager for in vitro diagnostics at Ohio-based medical research organization NAMSA, said serology tests can include point-of-care testing as well as lab-based testing.
Dozens of companies are working on such tests, Ravishankar said. More than 80 developers already have sought assistance from the FDA in developing and validating tests.
St. Paul-based Ativa Medical said the FDA's announcement Monday night on serology devices may speed up manufacturing and eventual distribution of its point-of-care device and its test for the new coronavirus.
The device, based on technology originally developed for the battlefield, detects subtle changes in the blood, including changes that happen even before antibodies appear.
Though a positive test for the coronavirus with an Ativa device would need to be confirmed with a more definitive test, it would flag individuals who show early viral patterns and should be tested and kept away from places like senior living centers in the meantime, CEO David Deetz said.
The key is to have the device's machine-learning system learn to identify unique patterns in COVID-19 infections and document that the system works as intended, which Ativa is doing now.
The FDA said the total number of tests available is rising with the number of new tests entering the market. However, the agency can't offer any tally at this point.
"We know that people want to know the current numbers of tests in the field and how many patients are being tested," the agency statement Tuesday said. "This number fluctuates daily as more and more test developers get their tests in the field and start testing patients. At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests."
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The governor said it may be 2027 or 2028 by the time the market catches up to demand.
