Biofire got FDA approval fast, but it hasn't done
Post# of 9144
Posted On: 10/28/2014 9:31:31 PM
Biofire got FDA approval fast, but it hasn't done much good so far:
http://7online.com/health/new-test-for-diagno...ed/369875/
NEW YORK (WABC) -- When it comes to Ebola, diagnosing patients early and finding their contact immediately is critical.
But when a five-year old boy who recently came back from West Africa started to have a fever Monday morning, New York City used a test that can take up to 12 hours.
Monday night, it came back negative.
But they had another option. A new test could have given them the answer in an hour.
So why didn't the city use it?
The Food and Drug Administration has approved the use of a one-hour Ebola test that can be done right in the hospital.
But at least for now, it won't be used here in New York, not until the city and state are convinced of its accuracy.
The medical device, the size of a small printer, can accurately test blood or urine samples for Ebola in one hour:
"Time can make a difference, every hour matters," said Kirk Ririe, CEO of BioFire Defense.
The head of the Midwest company that makes the one-hour Ebola testing machine says when the FDA gave the device an Emergency Approval for use by hospitals last Saturday, he was on his way to Bellevue to assist them in its use.
"We flew to New York, received clearance, authorization while we were in the air," said Ririe.
But we've learned that city and state health officials stepped in and stopped the use of the one-hour testing device despite F-D-A's emergency approval. That meant when the 5 year old boy back from Guinea was admitted to Bellevue's Ebola Ward, the next day, it took ten hours from the time he spiked a fever till his parents, medical staff, and the public found out, he did NOT have Ebola.
"Where's the urgency here?," Eyewitness News asked U.S. Senator Charles Schumer of New York.
"Well, the sooner you can get a test result, the better, but there's another thing that has to be involved too. You need total accuracy," said Ririe.
Senator Schumer says city health officials concerned about accuracy and training have delayed the use of the one-hour Ebola tester. It's clear however that the FDA felt confident enough in the device's accuracy to give it EMERGENCY APPROVAL.
The military has been using it in West Africa since last August and dozens of hospital including Bellevue already have the device for rapid testing of the common flu and other virus:
"Has the city told you when or is there a timeline here to when they're going to be using this?," we asked.
"The city has told us they're very interested, they're going to try to move it as quickly as possible, and I've urged them to move it as quickly as possible but make sure accuracy has to be first," said Schumer.
"The benefits of a fast result for a disease like Ebola speaks for itself. Every hour left untreated is an opportunity wasted," he said.
The city's Health and Hospital Corporation says that "this new test is currently being evaluated by the State and City Health departments, along with CDC partners, to insure it would be an effective tool."
The statement goes on to say that the city's current testing process is reliable and accurate.
No word from the state health department on how it will take to approve the new Ebola test.
http://7online.com/health/new-test-for-diagno...ed/369875/
NEW YORK (WABC) -- When it comes to Ebola, diagnosing patients early and finding their contact immediately is critical.
But when a five-year old boy who recently came back from West Africa started to have a fever Monday morning, New York City used a test that can take up to 12 hours.
Monday night, it came back negative.
But they had another option. A new test could have given them the answer in an hour.
So why didn't the city use it?
The Food and Drug Administration has approved the use of a one-hour Ebola test that can be done right in the hospital.
But at least for now, it won't be used here in New York, not until the city and state are convinced of its accuracy.
The medical device, the size of a small printer, can accurately test blood or urine samples for Ebola in one hour:
"Time can make a difference, every hour matters," said Kirk Ririe, CEO of BioFire Defense.
The head of the Midwest company that makes the one-hour Ebola testing machine says when the FDA gave the device an Emergency Approval for use by hospitals last Saturday, he was on his way to Bellevue to assist them in its use.
"We flew to New York, received clearance, authorization while we were in the air," said Ririe.
But we've learned that city and state health officials stepped in and stopped the use of the one-hour testing device despite F-D-A's emergency approval. That meant when the 5 year old boy back from Guinea was admitted to Bellevue's Ebola Ward, the next day, it took ten hours from the time he spiked a fever till his parents, medical staff, and the public found out, he did NOT have Ebola.
"Where's the urgency here?," Eyewitness News asked U.S. Senator Charles Schumer of New York.
"Well, the sooner you can get a test result, the better, but there's another thing that has to be involved too. You need total accuracy," said Ririe.
Senator Schumer says city health officials concerned about accuracy and training have delayed the use of the one-hour Ebola tester. It's clear however that the FDA felt confident enough in the device's accuracy to give it EMERGENCY APPROVAL.
The military has been using it in West Africa since last August and dozens of hospital including Bellevue already have the device for rapid testing of the common flu and other virus:
"Has the city told you when or is there a timeline here to when they're going to be using this?," we asked.
"The city has told us they're very interested, they're going to try to move it as quickly as possible, and I've urged them to move it as quickly as possible but make sure accuracy has to be first," said Schumer.
"The benefits of a fast result for a disease like Ebola speaks for itself. Every hour left untreated is an opportunity wasted," he said.
The city's Health and Hospital Corporation says that "this new test is currently being evaluated by the State and City Health departments, along with CDC partners, to insure it would be an effective tool."
The statement goes on to say that the city's current testing process is reliable and accurate.
No word from the state health department on how it will take to approve the new Ebola test.
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