'A game changer': FDA authorizes Abbott Labs' portable, 5-minute coronavirus test the size of a toaster - msnNOW
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CHICAGO – A five-minute, point-of-care coronavirus test could be coming to urgent care clinics next week, and experts say it could be "game-changing."
The U.S. Food and Drug Administration issued Emergency Use Authorization to Illinois-based medical device maker Abbott Labs on Friday for a coronavirus test that delivers positive results in as little as five minutes and negative results in 13 minutes, the company 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," FDA Commissioner Steve Hahn said in a statement. "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."
Scott Gottlieb, former FDA commissioner, echoed Hahn's comments on Twitter, calling the development a "game changer." Gottlieb also said it’s "very likely" that we’ll see additional approvals of point-of-care diagnostics behind this one, extending testing to doctor offices across the U.S.
The new test comes in the form of a small cartridge that fits in the palm of your hand, said John Frels, Abbott's vice president of research and development.
The test runs on the company's ID NOW platform, a 6.6-pound portable device the size of a small toaster. There are currently about 18,000 ID NOW instruments in the U.S. – the most widely available molecular point-of-care testing platform in the nation, Frels said.
Unlike high-throughput batch testing platforms that can run hundreds of tests at a time but take several hours, the ID NOW platform is a bench-top instrument used at physician offices and urgent care clinics. The platform is typically used to run tests for other respiratory illnesses, such as the flu, strep and RSV – and similarly uses samples from throat and nose swabs.
Last week, the FDA approved another coronavirus test from Abbott, the m2000 RealTime SARS CoV-2 EUA test, which is used for large batch testing at university and community hospitals. Between the two platforms, Abbott expects to produce about 5 million tests per month.
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"We believe that this pandemic is going to be fought at a number of levels, starting with the diagnostic front being able to clear the backlogs in testing. That's done by making high-volume throughput tests available and at the front lines as patients present themselves at urgent care," Frels said.
Abbott did not immediately say if it planned to manufacture more ID NOW platforms, in addition to the new test cartridges. Company spokesperson Darcy Ross said the company was working with the Trump administration to determine where the tests would be sent.
California-based Cepheid said last week that it received authorization for a test the company says gives results within 45 minutes. Another California-based company, Mesa Biotech, said Tuesday that it received authorization for a palm-sized test that the company says gives results in 30 minutes. The test is intended for use at temporary screening facilities, physician office labs, urgent care and long term nursing facilities.
The U.S. has struggled to ramp us testing across the nation, and, in the early days of the outbreak, the Centers for Disease Control and Prevention initially developed and mailed flawed testing kits. Many doctors have reported rationing tests to prioritize the most vulnerable.
Public health labs, as well as approved private labs, universities and hospitals, can conduct the tests. As of March 26, 92 public health laboratories in 50 states plus Washington D.C., Guam and Puerto Rico had successfully verified COVID-19 diagnostic tests and were offering testing, according to the CDC.
While there are no official nationwide testing totals, the COVID Tracking Project, an online effort started by two journalists to track the number of tests conducted in the U.S., said Friday that more than 620,000 tests had been completed nationwide – the most tests conducted by any country.
But the U.S., with a population of about 329 million, is not leading the world in the number of tests conducted per capita. South Korea, a country of about 51 million, had tested more than 370,000 people as of Friday, according to health officials. Italy, which has a population of 60 million and has reported the most coronavirus-related deaths, had tested more than 390,000 people, according to health officials.
Dr. Deborah Birx, the White House's coronavirus response coordinator, said in a Friday briefing that about 95% of testing in the U.S. is being done in commercial labs. The $2.2 trillion stimulus package approved Friday will require those labs to report total testing numbers, Birx said.
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Mary Hermiz, Medical Assistant and Adam Hansen, MD from Redirect Health, get ready to check on elderly patients at a drive-through testing site for flu and coronavirus on March 25, 2020 in Glendale, Arizona.
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Laboratory Technologist Roger Knauf, tests for COVID-19, the illness caused by the new coronavirus at Gravity Diagnostics in Covington, Kentucky Tuesday, March 24, 2020. The work is conducted in a secure area and the actual test is done behind glass. The lab was founded in 2016 and was approved for COVID-19 testing on March 16.
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A healthcare worker with the University of Nevada, Las Vegas School of Medicine tests a patient for the coronavirus at a drive-through testing site Tuesday, March 24, 2020, in Las Vegas. UNLV Medicine, the clinical arm of the UNLV School of Medicine, started conducting COVID-19 testing by appointment for people who meet the Centers for Disease Control and Prevention guidelines.
A car goes through the COVID-19 drive-through testing facility Monday, March 23, 2020, at the Memphis fairgrounds.
Police officers direct drivers as they enter Glen Island Park in New Rochelle, N.Y March 22, 2020. The park was the first site set in Westchester County set up for Covid-19 testing. New Rochelle was the epicenter of the spread of the Covid-19 virus after congregants of a neighborhood synagogue were the first to be diagnosed with the virus.
A resident of The Villages, Fla., gets tested for the coronavirus with a nasal swab at a drive-through site that accommodates golf carts, at The Villages Polo Club, March 23, 2020. The testing site is being operated by UF Health, with University of Florida medical students performing the tests. (Joe Burbank/Orlando Sentinel via AP) ORG XMIT: FLORL201
A healthcare worker prepares to swab a driver, Sunday, March 22, 2020, at Hard Rock Stadium in Miami Gardens, Fla. The National Guard opened a coronavirus drive-thru testing site Sunday testing first responders. On Monday, they planned to expand it to people at least 65 years old who are showing symptoms of the illness.
Healthcare workers take swab tests from citizens at the federally sponsored drive-thru COVID-19 testing site at TIAA Bank Field in Jacksonville, Fla. Sunday morning, March 22, 2020.
Stephanie Crilley, R.N., left, and nurse practitioner April Sweeney, at right, prepare to begin testing at the drive-through testing site at the AHN Health + Wellness Pavilion in Millcreek Township, Pa. Saint Vincent Hospital officials expected to test up to 40 patients daily at the site, which opened Friday. All patients tested must have a Saint Vincent Hospital physician referral and appointment. The samples will be tested for flu strains before they're tested for COVID-19, a new coronavirus.
Critical care nurse Molly Spaeny, left, with St. Vincent Healthcare speaks with a patient after administering a coronavirus test in a drive-thru testing center outside the hospital in Billings, Mont. Friday, March 20, 2020. For most people, the new coronavirus causes only mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia.
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Health workers put on personal protective equipment at a coronavirus COVID-19 drive thru testing location operated by Murphy Medical Associates at Cummings Park on March 20, 2020 in Stamford, Conn. We are still at the beginning of this public health emergency and it is my goal to ramp up our testing capacity as soon as possible, said Stamford Mayor David Martin. Communities throughout the United States have begun opening drive-thru sites to test people feeling potential symptoms of COVID-19 and that have a doctor's referral.
A sign sits on a barrier at a coronavirus COVID-19 drive thru testing location operated by Murphy Medical Associates at Cummings Park on March 20, 2020 in Stamford, Conn.
A health worker directs motorists at a coronavirus COVID-19 drive thru testing location operated by Murphy Medical Associates at Cummings Park on March 20, 2020 in Stamford, Conn.
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A member of the New York state National Guard holds a sign for drivers who came for COVID-19 testing, Thursday, March 19, 2020, at a state-managed coronavirus drive-through test site operating on it's first day on Staten Island in New York.
Hospital personnel assist people at a coronavirus screening tent outside the Brooklyn Hospital Center, Thursday, March 19, 2020 in New York. If they determine that someone may have the virus they are brought into the hospital for a full test.
Georgia Esoteric and Molecular (GEM) Lab research associate Yasmeen Jilani, seated, tests possible coronavirus samples at the GEM lab at the Medical College of Georgia in Augusta, Ga., Thursday morning March 19, 2020.
Healthcare workers screen patients who will be tested for COVID-19 at the FoundCare drive-thru testing station in Palm Springs, Fla. on March 19, 2020.
Healthcare worker Ludnie Emile prepares to test people for COVID-19 at their drive-thru coronavirus testing station in Palm Springs, Fla. on March 19, 2020.
New York State Department of Health worker gives instructions to a person seeking a coronavirus test at a COVID-19 drive-through testing site at Jones Beach State Park on Long Island, Wednesday, March 18, 2020, in Wantagh, N.Y. New York is among roughly ten states that have set up their own drive-through testing centers, as state and local leaders look to compensate for an acute shortage of tests in the United States.
A view of a checkpoint prior to entering to be tested for the coronavirus at Jones Beach State Park in New York.
A nurse in a hazmat suit swabs a woman's nose during a test for Coronavirus, COVID-19 at Somerville Hospital in Somerville, Mass. on March 18, 2020. A new stand-alone facility to test patients for COVID-19 open on March 18, 2020 in Somerville, Massachusetts. The testing center will be open only to patients within the Cambridge Health Alliance (CHA) system. Patients must call their primary care providers prior to being screened.
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Health care staff from the Community Health of South Florida, Inc. (CHI) prepare to test people for the coronavirus in the parking lot of its Doris Ison Health Center on March 18, 2020 in Miami, Fla.
Registered nurses and patient care technicians wait for their next patient to drive up to be tested for the coronavirus at Christenberry Fieldhouse in Augusta, Ga.
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'A game changer': FDA authorizes Abbott Labs' portable, 5-minute coronavirus test the size of a toaster - msnNOW
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