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FDA issues emergency approval for coronavirus test as outbreak nears 25,000 cases worldwide

Luxturna is the first gene therapy approved by the Food and Drug Administration that treats a medical condition -- in this case, blindness -- by fixing a mistake in a patient's DNA. (Spark Therapeutics/TNS)

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 pneumonia-like 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 virus-stricken 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. Messonnier on Wednesday said four more planes carrying passengers from Wuhan are making their way into the U.S. Two of those planes are heading to California, one is going to Nebraska and the other is bound for Texas.

“We do not believe these people pose a threat to the community where they’re being held,” Messonnier told reporters in a phone briefing, noting that CDC agents would screen those travelers immediately upon arrival.

As of Wednesday morning, the CDC has tested nearly 300 suspected cases. Seventy-six of them were still pending while 206 came back negative, including one at Manhattan’s Bellevue Hospital.


© 2020 New York Daily News