Posted on 03/28/2020 10:48:24 AM PDT by TaxPayer2000
The Abbott ID NOW™ COVID-19 test brings rapid testing to the front lines
- Test to run on Abbott's point-of-care ID NOW platform - a portable instrument that can be deployed where testing is needed most
- ID NOW has the largest molecular point-of-care installed base in the U.S. and is available in a wide range of healthcare settings
- Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day
- This is the company's second test to receive Emergency Use Authorization by the FDA for COVID-19 detection; combined, Abbott expects to produce about 5 million tests per month
ABBOTT PARK, Ill., March 27, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.
The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today.
"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 B. Ford, president and chief operating officer, Abbott. "With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."
Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.
The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched its Abbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about 5 million tests per month.
About the ID NOW™ Molecular Platform As the world leader in point-of-care diagnostics, Abbott is adding its expertise and scale to help fight the COVID-19 global pandemic. First introduced in 2014, ID NOW is the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S.
ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.
About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
SOURCE Abbott
For further information: Abbott Media: John Koval, (224) 668-5355; Darcy Ross, (224) 667-3655; Abbott Investor Relations: Laura Dauer, (224) 667-2299
Where are those machines manufactured?
Sounds like the machine manufacturing needs to be cranked up.
The reagents going at 10x what they have promised to do.
as long as it doesn’t involve a swab shoved to the back of the skull to get the sample
So, I saw something about parking lot testing with a line of cars waiting. Uh, if you aren’t feeling any of the symptons, why would you waste the time and a test kit? Just in case? Were some of these folks exposed or do they just want to join the club.
Knowing who is infected an who is not would help in traveling and getting the economy kicked off again.
Great news for quick point-of-service testing! LOVE American ingenuity!
Kudos to ABBOTT! I have ABBOTT stents in my heart for many years and still kickin’ !!!
The outside testing is to try to keep the hospital buildings uncontaminated.
In our town the drive-thru is located at a health-care system urgent care facility now exclusively purposed for the WuHuFlu. [There are currently 5 cases in the 6 County area so they are trying to get ahead of it.]
Apparently one has to get a note from a Quack to take the test.
Fortunately the State Lab has cleared its backlog and I think other labs are allowed to do testing now too.
So presumed not infected vs presumed infected sort of scenario? Forehead stamp? Hang tag like a handicap hang tag. Not infected today, infected tomorrow? I’ll just stay home and if we go out we’ll wear our pvc perimeter defense harness.
The fam is a bit spread out across the Country.
The tactics of grouping up are the issue.
The good news is the ID-Now hardware is already widely available and in use in the United States. More will obviously be needed, but this test can be widely implemented fairly quickly.
It is good and very timely news.
Kudos to Abbot.
Minutes, Not Hours: Rapid Testing for Coronavirus (52 sec.)
From SHOW MORE for this video…
"Combined with ID NOW, Abbott expects to produce about 5 million tests in April."Several Abbott COVID-19 related videos available.
Send Democrats and RINOs home in November!
MAGA, also KAGA! (Keep America Great Always!)
Supporting PDJT with a new patriot Congress that will promise to fully support his already excellent work for MAGA and stopping COVID-19 will effectively give fast-working Trump a third term in office imo.
Waiting for the media to ignore this story....oh...that’s right. They are doing that right now.
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