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Trump administration officials doubled down on their promise to deliver 1 million tests for the coronavirus this week as states reported limited testing supplies and federal lawmakers expressed doubts about the government's timeline.[CR-LF][CR-LF]Health and Human Services Secretary Alex Azar told reporters Thursday that a private manufacturer authorized to make the tests expects to ship the kits to U.S. laboratories by week's end. That amounts to the capacity to test roughly 400,000 people, given that it takes multiple test samples to a confirm a result.
Secaucus-based Quest Diagnostics, a provider of diagnostic information services, said Thursday it will launch a coronavirus test service.[CR-LF][CR-LF]The new test service aids the presumptive detection of nucleic acid in respiratory specimens of patients meeting CDC’s clinical criteria for COVID-19 testing. Quest will be in position to receive specimens for testing and begin to provide testing on March 9.
Quest Diagnostics, one of the largest commercial lab companies in the country, announced on Thursday it is launching a laboratory-developed test for the coronavirus next week, but it is unclear how many tests it will be able to run or how much it will cost. A spokesperson told POLITICO the test is in the process of being validated at Quest’s lab in San Juan Capistrano, Calif.
Quest Diagnostics plans to launch a nationwide testing service for the novel coronavirus next week—moving forward with its own assay after the FDA gave companies the green light to proceed with validated tests before receiving any agency review or authorizations.[CR-LF][CR-LF]The company described its lab-developed, molecular-based test as designed to detect viral RNA in respiratory specimens, and that it will be used for presumptive detection of the disease known as COVID-19.[CR-LF][CR-LF]Quest said it plans to begin receiving and testing specimens March 9, and will work to submit its test for agency review within the mandated 15-day timeline.
On Thursday, the total number of confirmed cases of COVID-19 in the U.S. that had been reported to the Centers for Disease Control (CDC) swelled to 100 -- and next week, that number is probably going to climb much further. That's because the country's second-largest provider of clinical testing services, Quest Diagnostics (NYSE:DGX), has announced plans to begin helping the CDC unwind its backlog of coronavirus tests.[CR-LF][CR-LF]During January and February, U.S. healthcare officials isolated some people at risk of carrying SARS-CoV-2, the virus that causes COVID-19. Unfortunately, a shortage of fully approved testing kits means that it's still unclear how many infected individuals may have slipped through the cracks. It's fairly likely to be a large number. In the past two months, just a few thousand people with suspected cases of COVID-19 were actually tested in the U.S.
Lab operators Quest Diagnostics Inc and OPKO Health Inc said on Thursday they would be able to begin testing for coronavirus from next week, as the U.S. government ramps up efforts to increase diagnostic capabilities.
Despite intense scrutiny and criticism of the diagnostic testing rollout in the US for the SARS-CoV-2 virus, the emergency regulatory process may actually be proceeding at a much more rapid pace than past emergencies, which did not involve newly-emerged pathogens.[CR-LF][CR-LF]Commercial tests in development to date have faced bottlenecks in test validation, but the logjam now appears to be clearing with new US Food and Drug Administration feedback and the availability of control materials.
After a weekslong delay, thousands of coronavirus test kits are headed to state and local laboratories, Vice President Mike Pence said Wednesday.[CR-LF][CR-LF]But questions remain about when, exactly, those promised test kits will arrive and how well they will work.
The Trump administration met with private lab test developers on Wednesday to discuss increasing the availability of tests for the coronavirus and said that the companies had formed a consortium. Vice President Mike Pence said the U.S. Department of Health and Human Services has included coronavirus testing as an essential health benefit for health plans in a bid to increase Americans’ access to tests.[CR-LF][CR-LF]“We want every American to have access to testing,” Pence said.
Thanks, Mr. Vice President. I appreciate the opportunity and your leadership on this matter. We understand this a public health issue that we all have a role in, and we’re deeply committed to working through this together.[CR-LF][CR-LF]We also appreciate the support of the FDA and the Centers for Disease Control. They’ve been very good partners in this regard. And particularly over the weekend — the decision that was made to give us — a decision that accelerated our path to bringing tests to the market place. As Adam said, we’re validating it as we speak. And, hopefully, by the next week, we’ll able to ramp that up at a number of our laboratories throughout this country.