By Thomas M. Burton
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.
The announcement comes as national testing efforts continue to fall far short of the levels recommended by public health doctors.
San Diego-based Quidel /zigman2/quotes/209081561/composite QDEL +2.26% , 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.
Leading public-health authorities have recommended that the U.S. do a minimum of four million or more tests every week.
Quidel already has placed about 36,000 test-analyzer instruments around the U.S. in places like hospital labs, emergency departments and doctors’ offices.
In its announcement, the FDA said the step was the first emergency use authorization for a Covid-19 antigen test. The agency said 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 per day due to their simpler design, helping our country better identify infection rates closer to real time.”