The Seattle company 's T-Detect test confirmed 97.1% of recent or prior COVID-19 infections, with 100% specificity in a recent study, the Seattle biotech said in a Friday statement.
T-Detect COVID is "the first indication in an entirely new class of tests that use T cells in the blood to detect disease," Chief Executive Chad Robins said.
"People who have been unsure about a prior infection will now have another way to know if they had the virus.”
The FDA provides emergency-use authorization to medical products that diagnose, treat or prevent serious or life-threatening diseases, where no approved alternatives are available.
T cells are the immune system's first responders to detect any virus. Adaptive's test uses those cells to determine whether someone has or has had COVID-19, which is responsible for nearly 60,000 deaths in the U.S. over the past 12 months.
Research shows that SARS-CoV-2 antibodies decline over time, so T cells are the better option for detecting the disease.
"We have proven that it is possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications," Robins said on Friday.
Adaptive Biotech shares at last check were 6.6% higher at $46. The stock was down nearly 30% year to date through Friday's session.