Many private laboratories in the U.S. are still not able to conduct their own tests, in part because of a demanding government approval process, leading lab experts and industry groups say.
that “timing may be impacted by high demand,” and that it would take weeks to ramp up testing. “We expect to be able to perform tens of thousands of tests a week within the next six weeks,” the company said in a statement.
“The risk is for further spread,” Dr. Christina Wojewoda, a pathologist at the University of Vermont Medical Center, said. “There are people who are positive and don’t know they are positive, and they aren’t staying away from elderly patients and those who are immuno-compromised.” The University of Vermont Medical Center has not developed a test in-house and does not have the equipment necessary to run the CDC’s test. So it is waiting for commercial manufacturers to develop a test that its lab can use, Wojewoda said. And getting the test isn’t the end of the process. “When we get it into the lab, we need to make sure it works in our hands,” she said, noting that the validation process could take another week to complete.
"We’ve had a lot of issues with payments not covering the cost of the tests,” Birenbaum said. “For our labs, it’s a big investment to gear up for this. We’re going to need to know if it’s at least going to cover costs."Other delays have bogged down laboratories’ ability to begin testing. “It shouldn’t have taken this long,” Perlin said. He added that while the lab’s staff was “clamoring” for the genetic material necessary to validate the test, “the CDC didn’t have vendors ready.”
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