FDA authorizes national use of first coronavirus diagnostic test

On Tuesday, the FDA issued an emergency use authorization to enable emergency use of the CDC’s diagnostic panel for the 2019 novel coronavirus, according to an agency press release.

Before the FDA’s emergency use authorization, use of the test — 2019-nCoV Real-Time PCR Diagnostic Panel — was limited to CDC laboratories. The new authorization allows its use at labs designated by CDC and, in the United States, labs certified to perform high complexity tests.

Test kits began shipping to public health labs Wednesday, according to Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases at the CDC.

“Initially, 200 test kits will be distributed to U.S. domestic laboratories and another 200 will be distributed to selected international laboratories,” Messonnier said during telebriefing Wednesday. “Each test kit can perform 700 to 800 patient samples. What that means is that by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients.”

She noted that, currently, each lab that places an order will receive one test kit, and

additional test kits are being produced and will be made available for ordering in the future through the International Reagent Resource.

“Distribution of these tests will improve the global capacity to detect and respond to this new virus as well as greatly enhance our national capacity. Availability of this test is a starting place for greater commercial availability of diagnostic testing for novel coronavirus,” Messonnier said.

Also during the telebriefing, Rear Adm. Denise Hinton, MS, chief scientist at the FDA, announced that the FDA has developed an emergency use authorization review template for tests that detect the novel coronavirus that outlines data to be developed in a pre-emergency use authorization package that is available to developers upon request. As of Wednesday, the agency has sent the template to 35 diagnostic developers.

“The FDA is committed to expediting the availability of critical medical products to prevent, diagnose and treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak,” Hinton said.

The 2019-nCoV diagnostic panel is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of the novel coronavirus from respiratory secretions, such as nasal or oral swabs, according to the press release. A positive result indicates likely infection. A negative result, however, does not preclude infection and should not be used as the sole basis of treatment or other management decisions. Combining a negative result with clinical observations, patient history and epidemiological information is important.

As Healio previously reported, HHS Secretary Alex Azar II declared a public health emergency over the coronavirus outbreak. It was determined that an emergency use authorization was important to fill the need for diagnostic testing, as there are no commercially available diagnostic tests.

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. 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,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “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.”

The novel coronavirus, which was first identified in Wuhan, China, in December, is a new type of coronavirus that can cause severe respiratory illness in humans. Most patients with confirmed infection have developed fever or symptoms of acute respiratory illness, such as cough or difficulty breathing. At present, though, limited information is available to characterize the full spectrum of clinical illness. Most reported cases outside of China have been associated with residence in or travel to Wuhan, and federal health officials said they believe that the risk from the virus to the general U.S. population is relatively low, according to the release. – by Melissa Foster

Disclosures: Azar is HHS secretary. Hahn is FDA commissioner. Hinton is chief scientist at the FDA. Messonnier is director of the National Center for Immunization and Respiratory Diseases at the CDC.