(This March 31 story corrects to remove reference to companies needing to apply for regulatory clearance; clarifies FDA guidance in 6th paragraph.)
By Carl O’Donnell
(Reuters) - Becton Dickinson and Co and diagnostics company BioMedomics on Tuesday said they will launch a diagnostic test that can detect current or past exposure to the coronavirus within minutes, and can be used in doctors’ offices, as well as other settings.
The test is the latest to join an arsenal of diagnostic tools for the coronavirus that can be used in community health settings such as doctors’ offices and urgent care clinics.
“This is a simple blood test that can be done at the point of care without the need to involve a large laboratory,” David Hickey, president of Becton Dickinson’s diagnostics division, told Reuters in a phone interview.
Abbott Laboratories on Friday won U.S. marketing approval for another coronavirus test that can deliver results to patients within minutes and be used in physicians offices and urgent care clinics. A week earlier, the U.S. Food and Drug Administration approved a test made by Cepheid that can be used at the point of care.
The United States now has more cases of the coronavirus than any other country, and hospitals have struggled to meet the demand to test thousands of people for the often-deadly virus.
The test from Becton Dickinson and privately-held BioMedomics is being released under the FDA’s recently relaxed rules for coronavirus tests, allowing the distribution of some tests before they receive regulatory clearance or without clearance entirely.
Becton Dickinson said it will begin distributing tests in April. It said it will have the capacity to produce 1 million tests and can scale up production further if necessary.
Point-of-care tests reduce the burden on laboratories to process samples of potential coronavirus patients and on hospitals to administer the tests. They also allow patients to be tested in a wider array of locations and receive results in as little as a few minutes.
The test can also play a role in understanding the process through which the disease spreads in the United States because of its ability to identify people who had a previous case of the coronavirus, Hickey said.
In some cases, patients who test positive for the coronavirus may need additional testing in a laboratory to determine the best course of treatment for the disease, Hickey said.
The FDA has also approved coronavirus tests on an emergency basis made by companies including Roche Holding AG and Thermo Fisher Scientific Inc .
With the expansion of testing has come a surge in confirmed cases of COVID-19, the disease caused by the coronavirus. Reuters reported on Friday that the United States now has more than 100,000 cases.