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The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.



The World Health Organization (WHO) is keeping an eye out for spread of a new coronavirus from Wuhan province in China to other countries, while the US Food and Drug Administration has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan.

The FDA would begin using its Emergency Use Authorization (EUA) process to clear the test kits, should the US Department of Health and Human Services (HHS) declare a public-health emergency on spread of the virus.

Meanwhile, US authorities are diverting and rerouting passengers traveling from Wuhan to the US to five major airports where they can be screened for the virus and prevent further infection.

“We stand ready to use our authorities to the fullest extent to help facilitate the development and ability of diagnostic tests for this virus, as we did during previous outbreaks such as MERS, Zika and Ebola,” FDA spokesperson Megan McSeveney told Medtech Insight.

The Pandemic and All-Hazards Preparedness Act of 2013 (PAHPRA) gave the HHS and the FDA the legal authority to strengthen national preparedness for public health, military and domestic emergencies involving chemical, biological, radiological and nuclear agents, including emerging infectious-disease threats.  (Also see "FDA Puts Strengthened Emergency Authority To Use For Diagnostics" - Medtech Insight, 3 Jun, 2013.)

The FDA is not allowed to expedite their approvals of in vitro diagnostic tests for emergency outbreaks of disease until the HHS declares a public-health emergency. Once that hurdle has passed, the agency may begin the process of issuing EUAs.

The FDA commissioner may issue an EUA for a specific diagnostic or other medical product after determining that:

>   The virus can cause serious, life-threatening conditions;

>   The product is effective in diagnosing, treating or preventing the disease;

>   The benefits of the product outweigh the risks; and

>   There is no adequate, approved or available alternative.

“Per our usual practice for responding to emerging infectious-disease outbreaks, the FDA is monitoring this situation and collaborating closely with other public-health agencies,” McSeveney said.

She added: “There are no commercially available diagnostic tests cleared or approved by the FDA for the detection of this novel corona virus. As the CDC (Centers for Disease Control and Prevention) has publicly announced, they are developing a diagnostic test to detect this new virus.”

Manufacturers Would Submit Pre-EUA Forms To FDA
The FDA has established an EUA process for evaluating novel tests during a public-health emergency. To gain an EUA for its diagnostic, a firm must:

1.   Email to request a copy of the most recent EUA review template relevant to the proposed test;

2.   Populate the draft template with information and data for the test; and

3.   Send the draft template back to the FDA for review as a pre-EUA submission, using instructions provided by the agency.

The FDA will ask for a detailed description of the in vitro diagnostic, including the target pathogen and whether the assay is based on molecular, antigen or antibody detection. The agency will want the proposed intended use of the IVD, as well as a summary of the test’s limits of detection, inclusivity, exclusivity, interfering substances, and any clinical data collected for the diagnostic to date.

Further, the FDA will ask for details about any analytical or clinical studies that are planned, but not yet started.

Challenges Of Development Detailed By Test Manufacturer
At least one US test manufacturer, Co-Diagnostics Inc., says it has begun work on a molecular-based screening test for the coronavirus.

“We are investigating the ideal diagnostic tools that would address the need for increased surveillance of the coronavirus 2019-nCoV, and have begun the principle design work for a PCR screening test based on the known available parameters,” said Rebecca Garcia, Co-Diagnostics’ VP of product development.

Garcia noted that some of the challenges of developing a diagnostic for a virus like coronavirus 2019-n CoV, “which entered the world so abruptly,” is the scarcity of available data. “Any test initially designed by Co-Diagnostics would use targets in the genetic sequence of the virus that have been published by the WHO, but such a test would also likely be improved and iterated upon, as time goes by,” she said in an interview.

“But as of this time, the US FDA has not determined whether a test for this virus could be made available for sale and distribution under emergency-use guidelines … so we have not yet begun to seek regulatory clearance,” Garcia added.

WHO Says Extensive Testing Needed For Suspected Cases
A WHO interim guidance issued on 17 January calls for rapid collection and testing of appropriate specimens for persons suspected of carrying the severe respiratory disease. Samples collection should include respiratory material, including nasopharyngeal and oropharyngeal swabs and sputum (if produced), and endotracheal aspirate or bronchoalveolar lavage in patients with more severe cases of the disease.

Serum for serological testing, acute sample and convalescent sample should also be collected, the WHO guidance advised.

Patients suspected of carrying 2019-nCoV should be screened for the virus with polymerase chain reaction (PCR) assays, which are designed to detect genetic sequences once sequencing information has been made available. According to the WHO, full genome sequence data from the viruses has been shared with the US and other countries by the Chinese government.

While there is limited information on the risk posed by the reported coronavirus, “it would appear samples prepared for molecular testing can be handled as would samples of human influenza,” the WHO interim guidance says.

More Screenings At US Airports
Screening was stepped up on 21 January for passengers potentially carrying Coronavirus arriving from China into the US, after a man in his 30s who came through the Seattle, WA, airport from the Wuhan area was found to have been infected with a strain of the virus. That person developed symptoms a couple of days after returning to his home in Snohomish County, WA.

At present, US authorities have rerouted all flights coming from the region to five airports where they can be reliably screened:  John F. Kennedy airport in New York; Los Angeles International Airport; San Francisco International Airport; Atlanta’s Hartfield-Jackson-Atlanta International, and Chicago’s O’Hare International.

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