Adaptive Biotechnologies unveiled a new type of test Wednesday for Lyme disease that may be most useful at detecting disease during the early stages of infection.
Conventional tests for the disease detect antibodies to the Lyme bacteria Borrelia burgdorferi, transmitted via a tick bite. But antibodies can take weeks to develop in the body, so the tests are often negative in the early stages of infection, such as when a patient first notices a rash from an infected tick.
Adaptive developed a way to detect Lyme disease by assessing the response of T immune cells. The Seattle company’s T-Detect Lyme test identifies T cells activated by the bacterium.
A preprint study, which has yet to be peer reviewed, found that Adaptive’s test was more sensitive than the standard test in patients with early Lyme disease. Fifty-six percent of cases were detected with T-Detect Lyme, compared with 30% by standard testing.
In a separate unpublished study, Adaptive’s test was 1.5 times more sensitive than standard testing in patients with a typical “bullseye” rash, picking up 54% of cases compared to 30%, according to a press release.
“A T cell test can improve upon existing options for patients and healthcare providers by measuring a different aspect of the immune response, the T cell, which can arise earlier than antibodies to help identify recent infections,” said Shari Rozen, an investigator of the second study, in a statement. Rozen is a physician at Preferred Primary Care Physicians of Pittsburgh.
T-Detect Lyme is available with a prescription as a service from clinical laboratories, which ship a blood sample to Adaptive for analysis. The test, which is not cleared or approved by the U.S. Food and Drug Administration, has a list price of $399, according to a spokesperson. Company discounts are available for eligible patients.
An estimated 476,000 people contract Lyme disease each year in the U.S., according to the U.S. Centers for Disease Control.
The new test is the second T cell-based test developed by Adaptive for patients. T-Detect COVID was released last year and has been used by more than 30,000 people testing for the coronavirus. The company is also developing T cell-based tests for inflammatory bowel disease, multiple sclerosis, and other conditions as part of its immune medicine platform.
The platform uses Microsoft’s cloud to characterize the T-cell repertoire from DNA sequencing by using artificial intelligence to identify a signal for disease.
As the company analyzes data from more Lyme disease patients, the sensitivity of T-Detect Lyme is likely to improve, said Sharon Benzeno, Adaptive’s chief commercial officer for immune medicine, in a statement. Company researchers anticipate an approximately 5% improvement, though they will gain a better understanding as they complete the analysis, said a spokesperson.
Adaptive also has developed tests for T cell responses used in research, and has an arm that sells products to detect “minimal residual disease” in cancer patients.
In an earnings call this May, Adaptive said it expected revenue for 2022 to range from $185 to $195 million. Operating expenses were $101.7 million for the first quarter this year and the company had $500.7 million in cash, cash equivalents and marketable securities on March 31.
In March, the public company streamlined operations and laid off 12% of its workforce, about 100 employees, citing market conditions. The value of Adaptive’s stock has plunged since its highs early last year, along with a major decline in the biotech stock market overall.