Japan's Ministry of Health, Labor and Welfare has approved QuantiFeron-TB Gold Plus (QFT-Plus) as an in vitro diagnostic to detect tuberculosis infection.
A spinout from Arizona State University's Biodesign Institute, the company is developing a MALDI-based blood test to identify patients with active infections.
The firm also announced the appointment of new board members as it heads toward commercialization of a portable MDx platform.
The company's microchip-based technology will detect viral and bacterial genetic material using both isothermal amplification and electrochemical measurements.
The portable device runs an isothermal amplification assay to detect genetic material from strains of tuberculosis in resource limited areas.
The firm expects full-year revenue of between $103 and $103.5 million, compared to a prior guidance of $103.5 to $104.5 million.
The companies are working together to pair Qiagen's QuantiFeron-TB diagnostic test with DiaSorin's Liaison family of automated analyzers.
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.