The researchers used a nanoparticle-based enrichment approach to detect the TB antigen LAM in urine, where it has traditionally been difficult to measure.
The grant was awarded under a program designed to help small businesses transition NIH-funded projects into the commercialization stage.
The tuberculosis and antibiotic-resistance test had been marketed in India by Xcelris Labs under a 2012 agreement.
The firm said that TB screening market growth was impacted by a slowdown in test utilization due to the White House's immigration policies.
Hema Diagnostic said that if current field trials are successful, the antigen-based lateral flow test could be used as a primary triage assay to rule out TB.
Oxford Immunotec sought a preliminary injunction to prevent the sale of the Qiagen product to new customers in the US.
The Ultra's combination of a lower limit of detection and ability to find dead bacilli after starting TB therapy vastly improves sensitivity compared to other tests, the study’s authors said.
The study is the first to demonstrate the design features and operational characteristics of Cepheid's Xpert MTB/RIF Ultra assay.
The company's year over year revenue growth was driven by continued growth in both its tuberculosis and tick-borne disease testing franchises.
The platform received 510(k) clearance from the US Food and Drug Administration for the expanded identification of mycobacteria, Nocardia, and molds.