Mark Sidney| Due to the urgency of the pandemic and the need to a solution, or at least a mitigation solution NOW, the Food and Drug Administration has issued an Emergency Use Authorization for, American corporation, Abbot Labs, a leader in the medical device field, on Friday.
The EUA was granted for a testing device that can take as few as 5 minuets to test a subject for the infamous COVID-19.
To give you an example of what we currently are using in New Jersey, my Uncle was tested for the virus 2 days ago and is still yet to hear back the results. My Brother-In-Law was tested yesterday and still awaiting to find out if he is positive. Both men have all the symptoms but are not being treated with off label medicines for COVID-19, nor will they be until and unless their tests come back positive.
The company will start supplying the machines starting next week and they will immediately ramp up the manufacture of the testing machines.’
FDA Commissioner Steve Hahn said:
“I am pleased that the FDA authorized Abbott’s point-of-care test yesterday. This is big news and will help get more of these tests out in the field rapidly. We know how important it is to get point-of-care tests out in the field quickly. These tests that can give results quickly can be a game changer in diagnosing COVID-19.”
Robert B. Ford, president and chief operating officer of Abbott added:
“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.”
The development was hailed as a “game changer” by former FDA commissioner Scott Gottlieb who said it is “very likely” there will be additional approvals for point-of-care diagnostics, “extending testing to doctor offices across the U.S.”
USA Today also reported the new tests will come in the form of a small cartridge that can fit in the palm of your hand, according to John Frels, Abbott’s vice president of research and development.
Abbott’s ID NOW testing platform is described as a portable 6.6-pound device that is about the size of a small toaster and is known for its high level of accuracy thanks to its molecular technology.
The company noted the platform is already “the most widely available molecular point-of-care testing platform” used in the U.S. today.