Source: U.S. Centers for Disease Control and Prevention
The U.S. Food and Drug Administration authorized the emergency use of a test developed by the Centers for Disease Control and Prevention to detect the new coronavirus that has been spreading throughout China and the rest of the world, infecting over 24,500 people.
The special authorization, granted Feb. 4, will permit broader use of the CDC's in-house developed real-time reverse transcription preliminary chain reaction test for the 2019 novel coronavirus, or 2019-nCoV, which has killed 492 people. All but two of the deaths have occurred in China.
The U.S. has reported 11 cases of 2019-nCoV in Washington state, Arizona, California, Chicago and California.
The CDC has been keeping tight control over testing of samples from people in the U.S. suspected of being infected with 2019-nCoV.
But that will now change under the FDA's action, which will allow any CDC-qualified laboratory in the U.S. to use the test.
"This will greatly enhance our national capacity to test for this virus," Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, told reporters on Feb. 3.
It only took one day for the FDA to approve the emergency authorization after the CDC submitted its request Feb. 3.
The CDC had already shipped its tests to the agency's International Reagent Resource program in anticipation of the approval so that states and international partners could begin ordering diagnostic tools for their use, Messonnier said during a Feb. 3 briefing with reporters.
The International Reagent Resource program provides registered users with reagents, tools and information for studying and detecting viruses, according to the CDC.
While Messonnier said the test is accurate, she said a negative result could mean that an infection has not developed enough to be detected by the test.
The symptoms of 2019-nCoV range from fever and cough to acute respiratory illness and difficulty breathing.
But officials noted that limited information is currently available to characterize the full spectrum of clinical illness associated with 2019-nCoV infection.
Since 2019-nCoV was first identified in late December 2019 in Wuhan, China — the epicenter of the outbreak — the FDA has been working with its partners across the U.S government and around the globe to expedite the development and availability of medical products to end the spread of the virus "as quickly as possible," Commissioner Stephen Hahn said a Feb. 4 statement.
"This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health," Hahn said. "Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible."
Late last month, Roche Holding AG said it also has a commercial test for coronavirus. But it has not received regulatory approval, so its results must be verified with other tests.
A number of companies are involved in coronavirus vaccine development, including Moderna Inc., Johnson & Johnson, Inovio Pharmaceuticals Inc. and GlaxoSmithKline PLC. Meanwhile, Gilead Sciences Inc., AbbVie Inc. and Regeneron Pharmaceuticals Inc. are among the drugmakers pursuing potential treatments.
The FDA noted that it can issue an emergency authorization to permit the use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition. It can do so when the secretary of the Department of Health and Human Services determines there is a public health emergency or a significant potential for an event that may affect U.S. national security or the health and security of U.S. citizens — and when there is a declaration that circumstances exist justifying the medical products' emergency use.
HHS Sec. Alex Azar declared a public health emergency in the U.S. on Jan. 31 for 2019-nCoV, an action that came a day after the World Health Organization declared a global emergency for the disease.
Azar told members of Congress on Feb. 2 that he may need to redirect up to $136 million from other programs under his transfer authority to respond to the coronavirus outbreak.
Azar had already secured $105 million on Jan. 25 for the U.S. response to 2019-nCoV.
Reps. Nita Lowey, D-N.Y., chair of the House Appropriations Committee, and Rosa DeLauro, D-Conn., head of the subcommittee that oversees HHS, urged Azar in a Feb. 4 letter to submit an emergency supplemental request to Congress rather than transferring funds from other programs.
They said the administration should submit the request no later than Feb. 10 — the same day President Donald Trump is expected to send his fiscal 2021 budget proposal to Capitol Hill.