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A new FDA-authorized COVID-19 test doesn’t need a lab and can produce results in just 5 minutes

There’s a new COVID-19 test from healthcare technology maker Abbott that looks to be the fastest yet in terms of producing results, and that can do so on the spot right at point-of-care, without requiring a round trip to a lab. This test for the novel coronavirus causing the current global pandemic has received emergency clearance for use by the U.S. Food and Drug Administration, and will begin production next week, with output of 50,000 per day possible starting next week.

The new Abbott ID NOW COVID-19 test uses the Abbott ID NOW diagnostics platform, which is essentially a lab-in-a-box that is roughly the size of a small kitchen appliance. It’s size, and the fact that it can produce either a positive result in just five minutes, or a negative one in under 15, mean that it could be a very useful means to extend coronavirus testing beyond its current availability to more places including clinics and doctor’s offices, and cut down on wait times both in terms of getting tested and receiving a diagnosis.

Unlike the rapid tests that have been used in other countries, and that received a new type of authorization under an FDA guideline that doesn’t confirm the accuracy fo the results, this rapid testing solution uses the molecular testing method, which works with saliva and mucus samples swabbed from a patient. This means that it works by identifying a portion of the virus’ DNA in a patient, which means it’s much better at detecting the actual presence of the virus during infection, whereas other tests that search the blood for antibodies that are used in point-of-care settings can only detect antibodies, which might be present in recovered patients who don’t actively have the virus.

The good news for availability of this test is that ID NOW, the hardware from Abbott that it runs on, already “holds the largest molecular point-of-care footprint in the U.S.,” and is “widely available” across doctor’s offices, urgent care clinics, emergency rooms and other medical facilities.

In total, Abbott now says that it believes it will produce 5 million tests in April, split between these new rapid tests and the lab tests that it received emergency use authorization for by the FDA on March 18.

Testing has been one of the early problems faced by the U.S. in terms of getting a handle on the coronavirus pandemic: The country has lagged behind other nations globally in terms of per capita tests conducted, which experts say has hampered its ability to properly track and trace the spread of the virus and its resulting respiratory disease. Patients have reported having to go to extreme lengths to receive a test, and endure long waits for results, even in cases where exposure was likely and their symptoms match the COVID-19 profile.

New York’s Governor Cuomo requires insurers to waive cost sharing for COVID-19 tests

In a move that other states might want to emulate, New York State Governor Andrew M. Cuomo said that the state’s Department of Financial Services is requiring health insurers in the state to waive cost sharing associated with testing for the new coronavirus, COVID-19.

The initiative paves the way for low-cost emergency room, urgent care, and hospital visits for patients worried that they may have contracted the virus.

The Governor also said that New Yorkers receiving Medicaid coverage will not be expected to pay a co-pay for any testing related to the novel coronavirus, COVID-19. The steps are designed to ensure that residents of the state won’t have to worry about cost as an obstacle for getting tested. Any tests that are being conducted at the State’s Wadsworth Lab are fully covered.

Cuomo’s administration also outlined other actions health insurers are either going to be required or advised to take — including informing New Yorkers of available benefits, offering telehealth medical advice and treatment, and preparing insurers to cover the costs of COVID-19 immunizations if a vaccine becomes available.

“We have the best health-care system in the world, and we are leveraging that system including our state-of-the-art Wadsworth testing lab to help contain any potential spread of the novel coronavirus in New York,” Governor Cuomo said, in a statement. “Containing this virus depends on us having the facts about who has it – and these measures will break down any barriers that could prevent New Yorkers from getting tested.”

The state’s initiative will prevent insurers from forcing cost-sharing on in-network provider office visits or urgent care visits, when the purpose is a test for the novel COVID-19 coronavirus. The initiative is also designed to ensure that New Yorkers receiving Medicaid coverage have their costs covered.

Employees who are in self-funded employer-based plans not regulated b ERISA statutes need to contact employers to see how the new regulations will effect them.

The State is also requiring insurers to devote resources to inform consumers of available benefits; provide and promote telehealth services; encourage and verify whether provider networks are adequately prepared to handle potential increases in demand for services including offering access to out-of-network services; covering the costs of immunizations if they become available; expand access to prescription drugs; and ensure proper emergency care.