QIA Qiagen NV

By Peter Loftus and Brianna Abbott 

Testing for the new coronavirus in the U.S. may ramp up quickly after the Food and Drug Administration said it would speed approval of tests from hospital and public-health laboratories to augment the limited supply from the federal government.

At a White House briefing Monday evening, FDA Commissioner Stephen Hahn said he expects the U.S. to have capacity for close to one million tests by the end of this week, from both public-health labs and private suppliers.

"We've heard from multiple companies and multiple academic centers, and we expect to have a substantial increase in the number of tests, this week, next week and throughout the month," he said.

Certain hospitals and health agencies around the country are working on their own diagnostics in addition to those in development from companies including Abbott Laboratories, Qiagen NV, Co-Diagnostics Inc. and bioMérieux SA.

Efforts to expand testing come as the illness caused by the virus spreads in the U.S., with new infections identified in people who hadn't traveled outside the country. More testing will be important to help allocate resources to the right patients, health officials say. Some other countries have already tested thousands of people but as of Saturday, about 470 people had been tested in the U.S. since Jan. 21, according to the Centers for Disease Control and Prevention's website, not including people who returned to the country on State Department- chartered flights.

A quick expansion of testing could produce a sharp increase in the case count in the U.S., though that wouldn't necessarily indicate the virus is spreading at the same rate, experts say.

"When you start giving diagnostic tests to people who never had them before you will almost certainly see an increase in declared cases," said Mark Miller, chief medical officer of French diagnostic-equipment maker bioMérieux. "Whether that's a true increase or a detection bias, that has to be figured out on the local level."

Initially developers of tests for coronavirus were required to obtain emergency FDA approval to ensure quality. The CDC test had been the only one approved for use in the U.S.

Some CDC test kits sent to state labs didn't function properly, however, and many public health labs needed to wait for replacements. A handful of states had functioning CDC tests -- sometimes providing results within hours -- while others had to send their samples back to the CDC for results, a process that could take days.

The agency has since ramped up test production and, facing pressure to expand testing quickly, federal authorities allowed state and local health departments to drop the part of their test kits that weren't working and move forward with the other components. Also, new test kits were manufactured and distributed. All positive diagnoses from the CDC-developed test, however, still need to be confirmed at the CDC's lab in Atlanta.

The Department of Health and Human Services has said it launched an investigation into the manufacturing defect in the early CDC testing kits.

The FDA now is allowing certified laboratories to develop and begin using new coronavirus tests while it reviews applications for approval. The FDA says these labs also have to follow certain guidelines aimed at ensuring the tests are valid. The FDA has communicated with more than 70 developers and public health labs working on their own tests, the agency says.

Most tests for coronavirus world-wide use a technique called a real-time PCR, or polymerase chain reaction, a commonly used tool to look for pathogens by identifying unique parts of their genetic codes and amplifying them. The test can be used to diagnose a range of infections including influenza, and has been adapted to identify the genetic sequence of the new coronavirus. Specimens can be collected via swabs of nasal or pharyngeal fluids.

The New York State Department of Health is testing coronavirus samples and providing hospitals with instructions to replicate the test in their own labs with the goal of providing roughly 1,000 tests a day.

Hackensack Meridian Health, which operates 17 hospitals in northern New Jersey, began developing diagnostic assays several weeks ago, and now plans to make them available in the coming days, said David Perlin, chief scientific officer for Hackensack Meridian's Center for Discovery and Innovation.

Hackensack Meridian's test can provide results in about two hours, and if positive, health-care workers could start treating a patient with supportive care while the specimen is sent to a state lab for confirmation. The hospital system could handle tests for about 50 to 100 patients a day if needed, but that capacity could be increased, Mr. Perlin said.

Mr. Perlin said that if the virus spreads widely, experienced local labs will be needed -- in tandem with government labs -- to manage large-scale testing.

Several companies are seeking federal regulatory approval for their coronavirus tests as well.

BioMérieux is developing two diagnostic tests for the new coronavirus, one of which is being developed under contract with the U.S. Department of Defense. That test delivers results for a single specimen within an hour and can be used outside of a lab if needed, such as at a border crossing or airport, said Mr. Miller, bioMérieux's medical chief. The second test can run hundreds of specimens at a time but takes about four to five hours for results.

The company expects to make the new tests available within the next several weeks, though regulatory approval could add to that timeline, Mr. Miller said.

Germany's Qiagen is adding a test for the new virus to existing diagnostic equipment. It is being used in a handful of Chinese hospitals and the company is seeking to expand distribution to other countries.

"We are now at the point where we need a decentralized solution that we can use more or less anywhere," Qiagen Chief Executive Thierry Bernard said in an interview.

Abbott Labs plans to make a coronavirus test available on its molecular diagnostic instruments, which are used in labs around the world, and on tests that can be given in doctor's offices, a spokeswoman said.

Salt Lake City-based Co-Diagnostics Inc. and San Diego-based Mesa Biotech also are developing tests for the new coronavirus.

--Betsy McKay contributed to this article.

Write to Peter Loftus at peter.loftus@wsj.com and Brianna Abbott at brianna.abbott@wsj.com

(END) Dow Jones Newswires

March 03, 2020 09:38 ET (14:38 GMT)

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