The test can be used in conjunction with other FDA-cleared Lyme enzyme immunoassays developed by GSD as part of a CDC-recommended modified two-tiered testing algorithm.
The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
The immune sequencing firm has engaged the FDA in discussions over how to get regulatory approval for one test for several seemingly different diseases.
The plan focuses on five scientific priorities to advance research and development over the next five years, including developing diagnostic tests for the diseases.