March 13, 2020 / 6:06 AM / 16 days ago

FDA works to speed coronavirus tests with Roche, New York approvals

ZURICH/NEW YORK (Reuters) - The U.S. Food and Drug Administration (FDA) issued emergency authorization for a faster coronavirus test made by Swiss diagnostics maker Roche (ROG.S) and allowed New York state to authorize certain labs to test for the virus, moves aimed at boosting screening capacity to help contain the growing epidemic.

U.S. testing was hampered by flawed kits distributed by the federal government in February, which gave some false results. That has set the country back in containing an outbreak that has infected more than 122,000 people worldwide and more than 1,660 in the United States.

The ramp-up has also been slowed due to regulatory hurdles, as well as logistical and technical challenges, despite the entrance of commercial lab companies Laboratory Corporation of America Holdings (LH.N) and Quest Diagnostics Inc (DGX.N), according to healthcare providers, public health officials and test makers.

“The system is not really geared to what we need right now,” Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Disease, said in a congressional briefing on Thursday. “That is a failing. Let’s admit it,” he said.

“The idea of anybody getting it easily the way people in other countries are doing it, we’re not set up for that.”

The new Roche tests provide results in 3.5 hours and can produce up to 4,128 results daily, the Basel-based company said on Friday, a boost to tests the company has offered until now.

The FDA’s Emergency Use Authorization clears the way for tests to be deployed in the United States and markets accepting the CE mark showing they conform to European standards.

In New York, labs that are authorized by the New York state’s health department will not have to get authorization from the FDA. They will only interact with New York’s health department, which should speed up the availability of testing there, the FDA said.

GOING TO THE LIMITS

Roche said it is “going to the limits of our production capacity” to deliver as many of the faster tests as possible.

“The virus is infecting people in an exponential way. We knew we had to go to the high through-put systems,” Roche Diagnostics head Thomas Schinecker said in an interview. “This will help isolate patients who are infected, so you can keep the others healthy.”

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

The tests are for two diagnostics systems: Roche’s cobas 6800, which can process 1,440 samples per day, and its faster cobas 8800, which can do more than 4,100. Worldwide, there are 695 cobas 6800 systems installed and 132 of the 8800s, with “more than 100” in the United States, Roche said.

Schinecker said Roche is in talks with the U.S. Centers for Disease Control and Prevention (CDC) over deploying more systems where they are most needed, including Washington state, where 31 of the nation’s 41 deaths have occurred.

The University of Washington School of Medicine has boosted capacity to 1,000 tests daily, but its labs have also faced supply chain issues, including too few people available to pick up specimens and take them to labs, officials there have said.

Reporting by John Miller and Michael Erman; Editing by Shri Navaratnam, Michael Shields and Stev Orlofsky

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