- Most people with COVID-19 in the US are legally prevented from knowing which variant infected them.
- That’s because sequencing tests have to be federally approved for results to be disclosed to doctors or patients, and most are not yet.
- Lab scientists say the process of validating the tests for approval is too costly and time-consuming.
- See more stories on Insider’s business page.
Sam Reider, a musician from San Francisco, got a call from the California Department of Public Health in June. Though fully vaccinated, Reider had recently tested positive for COVID-19 after teaching music at a summer camp. The health department asked him to take a second test at a local Kaiser Permanente.
Reider assumed it was because authorities wanted to find out whether he had a Delta infection. He, too, was curious – but when he got the test results back, he was surprised to learn that doctors couldn’t give him any information about his variant.
“When I got the follow-up from Kaiser, they said it’s positive, but they didn’t have any of the sequencing information,” Reider told Insider. That “felt odd to me,” he said.
Several legal barriers prevented Reider and his doctors – as well as nearly all Americans who have tested positive for the coronavirus – from knowing which variant was to blame.
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.
“I don’t think there’s a lot of motivation, quite honestly, to get that done,” Kelly Wroblewki, director of infectious diseases at the Association of Public Health Laboratories, told Insider.
Some patients, however, feel they’re being denied access to their own health information.
In some cases, knowing which variant is involved in an infection could inform how patients do their own contact tracing, since it informs how likely they are to have spread the virus others. (If it’s a Delta infection, for instance, they may want to notify a much wider circle of family and friends.)
Other patients, like Ryan Forrest, a 30-year-old in Midland Park, New Jersey, are simply curious to figure out how they were infected.
Forrest tested positive for COVID-19 after attending an indoor wedding in July. He said he didn’t have any personal interactions with the wedding’s “patient zero,” so he’s still wondering how he got sick – especially since he was vaccinated in March. Knowing that the Delta variant infected him could clear up confusion, he said.
“It would have been nice to know just for curiosity more than anything else,” he said.
Wroblewki said she “totally understands” that feeling.
“I would be curious. I think anybody would be curious,” she said. “The important thing to recognize is it’s a liability for laboratories to release the information.”
It’s arduous and time-consuming to validate a sequencing test
So far, Wroblewki said, more than 50 public labs in the US are capable of sequencing coronavirus samples to detect variants. 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,” Wroblewki 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.”
For a sequencing test to be validated, a manufacturer needs to collect data to show that the test does a good job of detecting a specific variant, then request emergency authorization from the Food and Drug Administration. Alternatively, laboratories can validate their sequencing tests “in house,” meaning they collect the same data so CMS can approve their test.
“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.
Validating a test for a single variant could take weeks to months, she added.
“To keep up with it in real time, when it doesn’t influence a decision you’re going to make on how you treat a patient, just isn’t very useful,” Wroblewki said. “It’s satisfying curiosity more than it’s really benefiting a patient.”
A more concerning variant could push scientists to disclose information to patients
The main purpose of sequencing, Wroblewki said, is to detect new variants and understand whether they challenge the effectiveness of vaccines, treatments, or diagnostic tests. Down the line, she said, labs also hope to get better at understanding whether certain variants cause more severe outcomes in certain populations, such as pregnant women or the elderly.
But right now, variants haven’t fundamentally changed the way people protect themselves from COVID-19. Though the Delta variant is the most contagious version of the virus yet, masks and social distancing still reduce its spread. And COVID-19 vaccines continue to offer good protection against severe disease and death.
“At this point, unless we see something that truly is going to direct your therapeutic choice at an individual patient level, there’s not a lot of benefit to a physician or a patient in knowing you have Delta,” Wroblewki said. “There’s nothing differently that a physician is going to do to treat that patient.”
That makes it hard to justify the time and expense of a validating a test, she added – particularly when those resources could be used to do more sequencing.
“If we see later there’s going to be true impact on a therapeutic that’s used to treat SARS-CoV-2, then yes, we’ll very likely change our approach,” Wroblewki said. “But at this moment, we’re not there yet.”