Becton Dickinson Seeks Emergency FDA Approval for a Two-Hour Coronavirus Test

Posted on: Tuesday, March 17, 2020 By: KorchekStaff

Becton Dickinson, a medical technology company, submitted a request to the Food and Drug Administration (FDA) for approval of what could be the fastest COVID-19 test on the market so far. The New Jersey-based company says its test could deliver results to hospitals in as few as two hours.

According to Becton Dickinson (BD) CEO Tom Polen, the test has already been used in China, including at the pandemic’s epicenter in Wuhan, and in Europe. The company has partnered with Alabama-based biotech company BioGX and asked the FDA for approval to use its test in the U.S. under the agency’s Emergency Use Authorization, which allows expedited review of new tests under emergency circumstances such as a pandemic. BioGX provides molecules and reagent products needed to formulate tests on the BD technology platform.

Already, some 500 hospitals across nearly every state in the country use BD’s testing machines and platforms to diagnose other respiratory illnesses, including the flu. So adding the COVID-19 test shouldn’t create an undue burden or require additional expertise. “I don’t think there will be tests that are any faster at this point than [two hours],” says Polen. “It’s a fully automated test so you snap in the test strip, put in the sample, close the door and press the button and the results come out in about two hours.”

Currently, health officials at state and local public health departments can use the manual Centers for Disease Control test, which takes at least 24 hours, or order tests from commercial testing companies which could take several days because samples have to be shipped to the labs.

Chinese health authorities used the BD platform to create their own test for COVID-19 as cases began spreading in Wuhan and throughout the country, and in the past week, European health officials also started to rely on the testing machines.

Polen says the company is also working on a separate, even faster test that could be available at retail clinics in the US and produce results in about 10 minutes. That test would run on another of the company’s machines — which is handheld and about the size of a cell phone — which tests for flu and strep, and is currently in 25,000 facilities like retail clinics and doctors’ offices. BD scientists are working with U.S. government researchers to identify the right antibody that could be used as a target for that test. Polen declined to predict how long it will take to develop, but when it becomes available, doctors could run the test in their offices, technicians could perform it in walk in clinics, or mobile teams of health care providers could test people in their homes to avoid transmission of the virus. “That would be a game changer to have a point-of-care, handheld test,” he says.

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