FDA grants approval for new, fast coronavirus test

ID NOW also has uses outside of COVID-19 testing as it can be used to test for Influenza A&B, Strep A and respiratory syncytial virus (RSV), according to Abbott.

By RACHEL WOLF, REUTERS
A medical technologist tests a respiratory panel at Northwell Health Labs, where the same test will be used on the COVID-19, the disease caused by the novel coronavirus, after being authorized to begin semi-automated testing by the US Food and Drug Administration (FDA) in Lake Success, New York, U.S (photo credit: REUTERS/SHANNON STAPLETON)
A medical technologist tests a respiratory panel at Northwell Health Labs, where the same test will be used on the COVID-19, the disease caused by the novel coronavirus, after being authorized to begin semi-automated testing by the US Food and Drug Administration (FDA) in Lake Success, New York, U.S
(photo credit: REUTERS/SHANNON STAPLETON)
The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) for a coronavirus test that promises to be the fastest on the market and claims to be able to deliver positive results in around five minutes and negative results in 13 minutes. Abbott Laboratories, the makers of the ID NOW coronavirus testing platform, says it expects to produce about 5 million tests in April.
The FDA also recently granted EUA to Cepheid, a coronavirus test which, according to CNN, provides results within 45 minutes.
"This is a significant leap forward," John Frels, vice president of research and development at Abbott, said in an interview with Reuters. "You can get a positive result in five minutes and a negative result in 13 minutes. You can walk into a clinic and literally get results while you are there."
Abbott says that the reason this test is “so different” is that it can be used in physicians’ offices or urgent care clinics and does not need to be administered in a hospital. ID NOW is a light box weighing approximately three kilograms (6.6 pounds). The company says it is “ramping up” to deliver 50,000 tests daily starting next week.

"Molecular testing technologies help detect the presence of a virus by identifying a small section of the virus' genome, then amplifying that portion until there's enough for detection. This process can cut testing wait time from hours, if not days, to as little as five minutes for positive results and 13 minutes for negative results," according to Abbott.
Abbott's ID NOW platform boasts the "largest molecular point-of-care footprint in the US and is already widely available in physicians' offices, urgent care clinics, and hospital emergency departments across the country."
Chris Scoggins, senior vice president of rapid diagnostics, said in a press release on Abbott's website that the tests will go "to healthcare professionals on the front lines, where testing capabilities are needed most. Portable molecular testing expands the country's capacity to get people answers faster."
"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," said Robert Ford, president and chief operating officer at Abbott, in a statement.
The company says that testing is key to controlling the pandemic and said providing healthcare providers with new technology for detecting the virus is a "top priority."
ID NOW also has uses outside of COVID-19 testing as it can be used to test for Influenza A&B, Strep A and respiratory syncytial virus (RSV), according to Abbott.
On Thursday, prior to Abbott receiving EUA, US Vice President Mike Pence hinted at the test’s development.
The US Centers for Disease Control and Prevention (CDC) says that while not everyone needs to be tested and it has specific guidelines to determine who should be tested, results can still mean more than knowing whether or not one has been infected. “Testing results may be helpful to inform decision-making about who you come in contact with.”
The CDC says it expects that most of the US population will be exposed to the virus in the coming months, and emphasizes the importance of practicing protective measures.


Related Tags
FDA - Food and Drug Administration
CDC