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Covid-19 infections are soaring across the United States in defiance of vaccination and natural immunity rates. But even as the ongoing pandemic continues to stump the experts, the Centers for Disease Control and Infection do not allow Americans to legally know the type of variant that he or she is infected with.
The legal prohibition against the ascertainment and disclosure of such Covid ‘variants’ information was reported in late August by Business Insider.
“The Centers for Medicare and Medicaid Service (CMS), which oversees the regulatory process for US labs, requires genome-sequencing tests to be federally approved before their results can be disclosed to doctors or patients,” the Insider reported. “These are the tests that pick up on variants, but right now, there’s little incentive for the labs to do the work to validate those tests.”
“I don’t think there’s a lot of motivation, quite honestly, to get that done,” Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories, told Insider.
“So far, Wroblewski said, more than 50 public labs in the US are capable of sequencing coronavirus samples to detect variants,” the report added. “But she’s not aware of any labs that have completed the validation process to get federal approval.”
“The process of validating a next-generation sequencing test is burdensome,” Wroblewski said. “It takes a lot of time. It takes a lot of data. It takes a lot of resources. And the thing about the variants is that variants of concern and of interest are constantly changing, so you would have to do a whole validation every time you have a variant.”
Thus, the process for discovering if a particular Covid case is a specific ‘variant’ is not currently allowed for under the law. This poll gives you free access to our premium politics newsletter. Unsubscribe at any time.
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“The letter of the law from CMS is that if you don’t go through this full validation process, you cannot release the results with patient identifying information,” Wroblewski said.
“At this point, unless we see something that truly is going to direct your therapeutic choice at an individual patient level, there’s not […]
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