The drug-device combination measures activity of live organisms by detecting metabolites, and can be used to indicate virulence and guide treatment.
The firm is taking its in-home monitoring systems for COPD and cystic fibrosis, and its professional-use sepsis confirmation system through clinical trials.
ProAxsis and a US-based biotechnology company codeveloped the assay as part of an ongoing collaboration. ProAxsis has made its first commercial sale of the test.
The multiplexed PCR kit will target mutations associated with cystic fibrosis that are highly prevalent in the US, and the firm is also eyeing the Middle East and Africa.
Agena's cystic fibrosis panel includes more than 70 mutations in the CFTR gene that have been linked to the disease.
The firm sees the new panel as an important step forward in its strategy to further penetrate the molecular diagnostics market with its qPCR products.