03-15-2020, 02:18 AM
(cont)
“These are usually very commercially available tests that every research lab uses; molecular biology labs across the world use these,” Mina said. “They’re very common and we don’t normally worry about them going out of stock. But at the moment, they are out of stock.’’Mina said that not only is the Qiagen product on backorder, so is another that might be used, from Roche. But part of the problem is that those reagents are used on different pieces of laboratory equipment made by their respective manufacturers. All labs wouldn’t have both.
“I would love to say, yes, there’s all these different options,” Mina said. “But we really run into problems because we can’t actually use these kits if we don’t have the instruments for them.”
The Food and Drug Administration said that it is monitoring the issue, and it hosted a webinar and town hall last week for the laboratory community as well as fielded questions from manufacturers about “alternative reagents, extraction methods, and platforms.” The agency also posted an FAQ page Tuesday on coronavirus diagnostic testing that lists potential alternatives. Mina said he was unsure that the page would speed up getting tests running, but said it at least clarified what needed to be done.
But the chemical for extracting RNA did not seem to be the only product running short as the U.S. tries to quickly ramp up its testing capacity. On Friday, Christopher Freeman, a laboratory administrator at Columbia University, sent an email to colleagues pleading for another product, used for storing RNA, made by Invitrogen, a unit of lab tools giant Thermo Fisher. He said his lab hoped to validate its Covid-19 test over the weekend, but that it needed the “a basic yet critical reagent that is required as per the FDA submission.” He asked if any laboratory had the reagent stocked in its laboratory.
A Columbia spokesperson said that the lab received a six-month supply of the necessary reagent from New York state and is in the process of validating its test. A Thermo Fisher spokesman said that the Invitrogen product should not be in short supply.
But some experts in the laboratory industry say that shortages may partly be the result of trying to have labs ready their diagnostics too quickly, and that preparations should have begun months ago.
Mike Pellini, a doctor and longtime diagnostics executive, said that it has been too difficult for new tests to come online and be reimbursed. In this case, work that should have taken two months has had to be “crammed into a few days or a week,” said Pellini, now a managing partner at Section 32, a venture capital firm.
“Industry has been prepared to engage for a while, but there was little receptivity on the other side until last week,” Pellini said.
_________________________________________________________________________
IOW^^^ the scientific community is not without blame re: "test kit" preparedness.
And I'll say again, I think any argument between an Ivy-League MBA (Trump) and an Ivy-League lawyer (Obama) is superfluous.
Who knew the best-equipped POTUS candidate 3 yrs ago would have been a black pediatric brain-surgeon, who would have eaten Wuhan virus, for breakfast.
Ben Carson.
“These are usually very commercially available tests that every research lab uses; molecular biology labs across the world use these,” Mina said. “They’re very common and we don’t normally worry about them going out of stock. But at the moment, they are out of stock.’’Mina said that not only is the Qiagen product on backorder, so is another that might be used, from Roche. But part of the problem is that those reagents are used on different pieces of laboratory equipment made by their respective manufacturers. All labs wouldn’t have both.
“I would love to say, yes, there’s all these different options,” Mina said. “But we really run into problems because we can’t actually use these kits if we don’t have the instruments for them.”
The Food and Drug Administration said that it is monitoring the issue, and it hosted a webinar and town hall last week for the laboratory community as well as fielded questions from manufacturers about “alternative reagents, extraction methods, and platforms.” The agency also posted an FAQ page Tuesday on coronavirus diagnostic testing that lists potential alternatives. Mina said he was unsure that the page would speed up getting tests running, but said it at least clarified what needed to be done.
But the chemical for extracting RNA did not seem to be the only product running short as the U.S. tries to quickly ramp up its testing capacity. On Friday, Christopher Freeman, a laboratory administrator at Columbia University, sent an email to colleagues pleading for another product, used for storing RNA, made by Invitrogen, a unit of lab tools giant Thermo Fisher. He said his lab hoped to validate its Covid-19 test over the weekend, but that it needed the “a basic yet critical reagent that is required as per the FDA submission.” He asked if any laboratory had the reagent stocked in its laboratory.
A Columbia spokesperson said that the lab received a six-month supply of the necessary reagent from New York state and is in the process of validating its test. A Thermo Fisher spokesman said that the Invitrogen product should not be in short supply.
But some experts in the laboratory industry say that shortages may partly be the result of trying to have labs ready their diagnostics too quickly, and that preparations should have begun months ago.
Mike Pellini, a doctor and longtime diagnostics executive, said that it has been too difficult for new tests to come online and be reimbursed. In this case, work that should have taken two months has had to be “crammed into a few days or a week,” said Pellini, now a managing partner at Section 32, a venture capital firm.
“Industry has been prepared to engage for a while, but there was little receptivity on the other side until last week,” Pellini said.
_________________________________________________________________________
IOW^^^ the scientific community is not without blame re: "test kit" preparedness.
And I'll say again, I think any argument between an Ivy-League MBA (Trump) and an Ivy-League lawyer (Obama) is superfluous.
Who knew the best-equipped POTUS candidate 3 yrs ago would have been a black pediatric brain-surgeon, who would have eaten Wuhan virus, for breakfast.
Ben Carson.