Federal Regulations Keep COVID Patients in the Dark About Which Variant They Have
It should be relatively easy for coronavirus patients who want to know what variant of COVID-19 they’ve been infected with to obtain that information. After all, at least 50 public laboratories in the U.S. are capable of testing COVID-19 samples to detect virus variants. But onerous federal regulations keep this health information out of reach.
“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,” notes Insider. “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.”
That’s because doing so is illegal without federal approval, and getting that approval is an involved, expensive, and uncertain procedure. It requires completing a validation process that would have to be newly undertaken for each new variant a lab wanted to test for.
“The process of validating a next-generation sequencing test is burdensome,” Kelly Wroblewski, the Association of Public Health Laboratories’ director of infectious diseases, told Insider. “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.”
As a result, patients and the public are left with less information about the virus’ spread—information that could be useful for preventing future infections and outbreaks. For instance, someone infected with the delta variant has more cause to alert vaccinated people they’ve been in contact with than does someone infected with the original strain. And knowing which variants are spreading in a given community, or spreading most quickly, could also provide key information (things like new variants gaining ground, higher transmissibility potential, if some variants seem more prevalent in certain populations, etc.) and early warning signs as we deal with this virus’ mutations going forward.
Genetic sequencing of COVID-19 tests was approved by the Food and Drug Administration (FDA) in June 2020. (The FDA, CMS, and the Federal Trade Commission all have a say in genetic testing regulation.) And epidemiologists are allowed to disclose variant status in certain situations, for certain purposes. From Insider:
“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,” Wroblewki said. One major exception, she noted, is if epidemiologists need to disclose a person’s variant information over the course of contact tracing.
But under the current regulatory regime, patients—and therefore their communities and the public at large—are left in the dark.
PBS warned way back in February about the problems this can create:
Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged
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