FDA issues emergency approval for coronavirus test
Outbreak nears 25,000 cases worldwide
The federal government has issued an emergency order allowing its coronavirus test to be used by state health labs nationwide, speeding up efforts to detect and contain new cases of the mysterious new illness.
Since the first cases of the pneumonialike virus were confirmed in the U.S. last month, the test could only be done at the U.S. Centers for Disease Control and Prevention’s own labs.
But the rapidly growing outbreak, which is concentrated in China, has since been declared a public health emergency in the U.S. as officials race to keep the number of cases in this country as low 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,” Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration, said in a statement Tuesday.
Test kits were expected to be shipped to more than 100 labs across the U.S. within the next few days. Starting next week, potential new cases will be confirmed by those labs directly, instead of the CDC, the federal agency announced Wednesday.
Dr. Nancy Messonnier, director of the CDC’S National Center for Immunization and Respiratory Diseases, said the new measures would “greatly enhance” the government’s capacity to test and treat new cases and will set the path for the kits to be available commercially in the near future.
The newly discovered virus has sickened 11 people across five U.S. states – Arizona, California, Illinois, Massachusetts and Washington. But the number of confirmed cases in mainland China was close to 25,000 on Wednesday, with 490 deaths.
Most of the patients affected so far are from central China’s Hubei province, where the virusstricken city of Wuhan is located. The first confirmed cases are linked to a large animal and seafood market in that city, though the exact source of the virus remains unknown.
The viral infection can cause respiratory illness and most patients have developed mild symptoms, such as fever and cough.
Even as they declared the outbreak a public health emergency last week, U.S. officials insisted the threat to the general public remains low because there’s no evidence the virus is spreading in this country. Nearly all U.S. patients had recently returned from China when they were diagnosed with the disease.
U.S. travelers returning from China have been quarantined at military bases.