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FDA grants EUA for antigen test (85% sensitivity)...

FDA Grants Emergency-Use Status for First Coronavirus Antigen Test

https://www.wsj.com/articles/fda-to-grant-emergency-use-status-for-first-coronavirus-antigen-test-by-quidel-corp-11589031815?mod=e2tw

WASHINGTON—The Food and Drug Administration has granted emergency-use authorization to Quidel Corp. for the first antigen test for the Covid-19 virus.

An antigen test looks for the disease itself, as opposed to antibody tests that look for traces of past exposure.

San Diego-based Quidel, which specializes in tests for flu, strep and infectious diseases among other conditions, relies on a decades-old technology to detect the disease with its test. Other current tests are more complex both to conduct and analyze.

Quidel already has placed about 36,000 test-analyzer instruments around the U.S. in places like hospital labs, emergency departments and doctors’ offices.

“We are ramping up manufacturing to go from 200,000 tests next week [week of May 11] to more than a million a week within several weeks,” said Douglas Bryant, Quidel’s chief executive.

The announcement comes as national testing efforts continue to fall far short of the levels recommended by public-health doctors.

The FDA said Saturday that antigen tests are “a new type of diagnostic test designed for rapid detection of the virus that causes Covid-19.”

It said that the most commonly used test for Covid-19 until now, known as a PCR test, magnifies virus particles to ease their detection. The agency added it “can be incredibly accurate, but running the tests and analyzing the results can take time.”

The agency also noted that these antigen tests can normally be produced at lower prices than PCR tests and “can potentially scale to test millions of Americans a day due to their simpler design, helping our country better identify infection rates closer to real time.”

Quidel’s technology uses nasal swabs to produce samples that are run on the company’s Sofia analyzers, which can be read in minutes.

“We want to be able to test people quickly,” said Mr. Bryant. “We want people to be able to get a test at an urgent-care center or a retail clinic.”

He said his company’s data show that their test is about 85% “sensitive,” or able to identify the new coronavirus when it is present.

The U.S. currently is running tests at a rate under half of the optimal level needed to be sure that the public is safe to go back to work and resume other activities, according to many public-health experts.

A minimum of four million tests weekly is needed, followed up with contact tracing, Ashish Jha, director of the Harvard Global Health Institute, said. He added that antigen testing has been viewed, along with newer genetic testing techniques such as Crispr, as a solution to the difficulty of ramping up the national testing regimen.