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>The Centers for Medicare and Medicaid Service (CMS), which oversees the regulatory process for US labs, requires genome-sequencing tests to be federally approv
by LordDragonfang 5y ago
>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. 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.
Seems to be a side-effect of reasonable laws that weren't written with emergency-use authorisation pandemic measures in mind, and pharma lawyers following the letter of the law to avoid liability. Should be easy enough to fix with, at worst, an executive order.