U.S. FDA approves first rapid coronavirus test with 45 minutes detection time

By Kanishka Singh

(Reuters) – The U.S. Food and Drug Administration has approved the first rapid coronavirus diagnostic test, with a detection time of about 45 minutes, as the United States struggles to meet the demand for coronavirus testing.

The test’s developer, California-based molecular diagnostics company Cepheid, said on Saturday it had received an emergency use authorization from the FDA for the test, which will be used primarily in hospitals and emergency rooms. The company plans to begin shipping it to hospitals next week, it said.

The FDA confirmed its approval in a separate statement. It said the company intends to roll out the availability of its testing by March 30.

Under the current testing regime, samples must be sent to a centralized lab, where results can take days.

“With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” U.S. Secretary of Health and Human Services Alex Azar said on Saturday.

The United States is not even close to meeting domestic demand for coronavirus testing. Many medical experts have predicted that delayed and chaotic testing will cost lives, potentially including those of doctors and nurses.

On Friday, Anthony Fauci, director of National Institute of Allergy and Infectious Diseases, was asked whether the United States can currently meet demand for tests.

“We are not there yet,” Fauci said.

The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said.

The systems do not require users to have special training to perform testing, and are capable of running around the clock, Cepheid President Warren Kocmond said in the statement.

The company did not give further details or say how much the test will cost.

The U.S. FDA has been pushing to expand screening capacity for the virus while the World Health Organization has called for “order and discipline” in the market for health equipment needed to fight the outbreak.

(Reporting by Kanishka Singh in Bengaluru; Editing by Sonya Hepinstall and Daniel Wallis)

Don’t eat romaine: U.S., Canada warn on E.coli in lettuce

FILE PHOTO - Romaine lettuce grows near Soledad, California, U.S., May 3, 2017. REUTERS/Michael Fiala

(Reuters) – Public health officials in the United States and Canada on Tuesday warned against eating romaine lettuce while they investigate an outbreak of E. coli that has sickened 50 people in the two countries, including 13 who were hospitalized.

The alerts, issued as millions of Americans plan their Thanksgiving Day menus, covered all forms of romaine, including whole heads, hearts, bags, mixes and Caesar salad.

Officials were uncertain of the source of the tainted lettuce.

“Consumers who have any type of romaine lettuce in their home should not eat it and should throw it away, even if some of it was eaten and no one has gotten sick,” the U.S. Centers for Disease Control said in its food safety alert.

Refrigerator drawers and shelves where romaine lettuce had been stored should be sanitized, the CDC said.

The Public Health Agency of Canada, which is investigating 18 of the E. coli cases, directed its romaine lettuce alert at consumers in Ontario and Quebec.

In the United States, the CDC said the outbreak affected 32 people in 11 states between Oct. 8 and 31. No deaths have been reported, it said.

Symptoms of the infection often include a moderate fever, severe stomach cramps, vomiting, and diarrhea, which is often bloody, the CDC said. Most people get better in five to seven days, but it can be life-threatening, it said.

The agency said the current outbreak is unrelated to another multi-state rash of E. coli infections related to romaine lettuce earlier this year that left five people dead and sickened nearly 200.

The U.S. Food and Drug Administration and the CDC traced the origin of that contamination to irrigation water in the Yuma, Arizona, growing region.

(Reporting by Peter Szekely in New York; Editing by David Gregorio)