The Food and Drug Administration or FDA issued an emergency use authorization for a new coronavirus test from Quest Diagnostics.
The company said that the authorization from FDA would allow people to collect their sample from home.
Quest Diagnostics will manufacture over 500,000 of the kits available by the end of next month. With the self-collection kit, people can expect a swab that allows them to collect a sample from their nostril that can then be delivered by FedEx to a laboratory.
“COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection,” Quest CEO Steve Rusckowski said in a statement.
“The self-collection kit enables an individual to self-collect at home, and the process is far less invasive and uncomfortable than many traditional methods," he added.
Self-collection
Shares of Quest rose by about 2.2%. The new coronavirus test recognized by FDA from Quest Diagnostics is not the first to allow self-collection and deliver it to a lab. In April, the FDA approved the first such collection kit from testing giant LabCorp.
According to Quest, its new test involves the use of a specimen collection approach similar to other Quest tests applied in health-care and drive-thru settings. The company added it plans to distribute the tests to health care workers, states, and businesses as part of “return-to-work testing programs.” The company did not mention any timeline for how long the results of the test will be released.
Quest is currently holding about 80,000 tests per day and plans to increase that up to 150,000 by the end of June, according to Rusckowski. He noted that equipment shortages and delays in sample collection hindered them in increasing their testing capacity.
“We need to have the swabs and those capabilities in place to be able to do those kinds of volumes,” he said. “We have put a lot of energy around the ... capacity for collecting the specimens. That front end is quite important.”
The authorization of FDA for the new test comes as the US has failed to boost its capacity to test people for Covid-19. The country's ability to detect the virus before individuals get hospitalized was affected by early missteps and supply chain shortages.
The US held an average of about 173,000 tests per day through April, based on the data compiled by the Covid Tracking Project. Capacity increased twice since and the US has so far held an average of 330,000 tests per day in May, the volunteer effort founded by reporters at The Atlantic magazine shows.
However, the number of tests being held is not sufficient based on what some economic and public health specialists have stated is needed.
Mass testing
Over 15 million tests have been processed in the US based on the figures of Covid Tracking Project. The US recorded more than 329 million residents, according to the U.S. Census Bureau.
Increasing mass testing of both symptomatic and asymptomatic people can improve the confidence of Americans returning to work as well as in identifying sources of infection before they develop into outbreaks, according to public health specialists and business executives.
Former FDA commissioner Dr. Scott Gottlieb stressed the importance of widespread testing capacity with some epidemiologists predicting a rise in infections when the weather changes this fall.
“We still need to figure out ways to get testing into sites and encourage asymptomatic or mildly symptomatic screening or we’re going to be in a difficult situation heading into the fall,” Gottlieb said during an interview with CNBC’s “Squawk Box” earlier Thursday.
