The agency also cleared Roche's assay for diagnosing thyroid or pituitary disorders, as well as tests from Beckman Coulter, Immunostics, and BioMérieux.
The IGRA testing market is ballooning as industrialized nations try to curb the spread of tuberculosis, but the assays still fall short in certain settings and patient populations.
In 2016, the Korea Centers for Disease Control and Prevention selected the assay to screen individuals at risk of infection through close contact with active TB patients.
The firm is developing an electrochemical sensor platform to detect sepsis and other conditions using a single drop of blood and a single-use cartridge.