FDA Approves Becton Dickinson’s 15-Minute Handheld Rapid COVID-19 Test
NEW YORK, NY - APRIL 16: A COVID-19 IgG and IgM Rapid Test Cassette are displayed on April 16, 2020, in New York City. The take-home test says they can tell a person if they have Coronavirus antibodies in their system, thus indicating that they have had the virus. Hospitals in New York City, which have been especially hard hit by the coronavirus, are still struggling with an influx of COVID-19 cases.
The Food and Drug Administration on Monday, granted Becton Dickinson, an emergency-use authorization for its BD Veritor Plus system. This was announced in a statement the company released.
Designed with almost the same size as a mobile phone, this handheld product is part of a new antigen testing technology, promising to bring more rapid and affordable testing to doctors'
clinics, "urgent-care centers and other health care facilities."
In connection to this, the first test from Quidel Corp., Bloomberg reported, was cleared for the United States in May. The Shares of Becton Dickinson increased by 4.4 percent to $255.90 per share in premarket sales.
In an interview, Tom Polen, chief executive officer of Becton Dickinson, said, this new product is a "breakthrough technology in the fight against COVID-19.
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An Answer to Shortage in Testing Supplies and Equipment
The test design and procedure's simplicity, according to reports, allows it to be administered "be administered in more routine backgrounds" with reduced practice and learning in the laboratory.
Also, according to the report, since the early weeks of the COVID-19 pandemic, the US has been struggling with a shortage of "testing supplies and equipment."
Such scarcities have resulted in long lines for COVID-19 testing in the so-called "new hotspots" such as Florida, Texas, and Arizona. They loom to weaken containment initiatives as the country sees record rises in reported COVID-19 cases.
Due to high demand for testing for the virus, Quest Diagnostics Inc., a commercial lab, on Monday said, "Average wait times for test results" have increased to up to five days for cases that are non-priority.
Meanwhile, with this new rapid testing equipment, high-priority patients get their results only after one day. Faster answers let people who test positive with the virus to go on quarantine much faster and support public-health tasks such as contact-tracing that stems spread of the COVID-19.
Detecting Strep Throat and Flu
This new product of Becton Dickinson is being operated through its "Veritor Plus" system, which is employed already in over 25,000 locations in the US for the detection of flu and strep throat.
Manufacturing of this handheld rapid COVID-19 test has reportedly started, and shipping begins instantaneously, as well.
At present, Becton Dickinson is planning to make up to ten million testing devices by end-September. It also announced, it is "working toward a specific capacity to produce two million handheld tests each week.
The good news about this latest development to combat COVID-19 is that the newest antigen testing device is more affordable for the purchase and use of medical equipment.
For example, today's rapid ID NOW system of Abbott Laboratories is priced at thousands of dollars. The Veritor Plus System of Becton Dickinson is priced, on average, at $250 to $300.
More so, according to Polen, the test devices themselves are priced roughly $20 each. As for Quidel, Scott Gottlieb, FDA Commissioner said, its test could have a price of as little as $5 to use.
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For Home Use
Also, according to Polen, "People keep on saying," for the COVID-19 test, they want to have one for their house. However, the clearance from FDA necessitates the test for use only in clinical settings "that meet certain regulatory requirements."
Despite being promoted as a promising device, doubts about accuracy have determined even the diagnostic tests regarded as "the gold standard" for the pandemic.
The same questions occur with antigen tests. Meanwhile, in clinical trials, the product of Becton Dickinson had reached around 84-percent sensitivity, which gauges the rate of real positive results, the company statement indicated on Monday.
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Jul 07, 2020 08:20 AM EDT
