Despite recent COVID-19 surges largely due to the spread of the delta variant and vaccine hesitancy, most physicians and their patients are legally prevented from knowing which variant infected them because of regulatory hurdles, Insider reported.
That's because CMS requires genome-sequencing tests to be federally approved, a process that lab scientists say is too costly and time consuming to be done for every patient.
There are 50 public labs in the U.S. that can sequence COVID-19 samples, but Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories, told Insider that she doesn't know of any labs that have completed the validation process to get federal approval.
"The process of validating a next-generation sequencing test is burdensome," Ms. 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."
The one exception, Ms. Wroblewski said, is if epidemiologists need to disclose a patient's variant information during contact tracing.