[D66] FDA keurt met spoed nieuwe coronavirus test goed (Wuhan Coronavirus 2019-nCoV #85)

[Dr. Marc-Alexander Fluks]

Bron:   The Hill
Datum:  27 maart 2020
Auteur: Brooke Seipel
URL:    
https://thehill.com/policy/healthcare/489959-fda-authorizes-15-minute-coronavirus-test


FDA authorizes 15-minute coronavirus test
-----------------------------------------

The U.S. Food and Drug Administration (FDA) has issued Emergency Use 
Authorization for a new coronavirus test that takes just 15 minutes to 
complete.

The test's maker, Abbott, announced the news Friday evening in a press 
release, saying it plans to start delivering 50,000 tests per day 
starting next week.

Abbott will run the tests on its point-of-care ID NOW platform, a 
portable platform that weighs less than 7 pounds and can be deployed to 
coronavirus hotspots. The company said it expects to produce about 5 
million tests per month.

It marks one of the fastest tests for COVID-19 available and comes just 
a week after the FDA approved another 45-minute rapid point-of-care 
test.

The approval comes as cities across the nation scramble to get testing 
done and prevent the spread of the coronavirus. The United States on 
Thursday became the country with the largest number of cases, surpassing 
China and Italy, and on Friday, the U.S. hit more than 100,000 diagnosed 
cases of COVID-19.

The availability of testing has been a point of contention as the 
pandemic has unfolded. On Friday health officials in Arizona warned that 
the state may soon be unable to continue testing people for COVID-19 
because of a lack of testing kits.

The outbreak is expected to worsen in the coming days and weeks as the 
upward trajectory continues. The U.S. is now adding more than 14,000 new 
cases per day.

Experts say that a key factor in ending the spread of the virus and 
reopening the economy is to dramatically increase testing capacity. With 
increased testing, measures like keeping everyone at home can be 
replaced with more targeted identification and isolation of sick people.

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(c) 2020 The Hill

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Bron: Abbott
Datum: 27 maart 2020
URL:   
https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes


Abbott launches molecular point-of-care test to detect novel
Coronavirus in as little as five minutes
------------------------------------------------------------
- The Abbott ID NOW(tm) 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(tm) 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(tm) RealTime SARS-CoV-2 EUA test, 
which runs on the m2000(tm) 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.

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(c) 2020 Abbott