The assay runs on the Panther Fusion system, which combines transcription-mediated amplification, real-time TMA, and real-time PCR with full sample-to-result automation.
The firm said that it will soon apply for a CLIA waiver of the second-generation test,which can report positive results in as little as five minutes
The CDC received clearance for a number of influenza panels and kits. Agilent's assay for postnatal CNV detection, and Abbott's hematocrit test were also cleared.
The panel, developed by collaborator Janssen, is expected to improve detection of influenza and respiratory syncytial virus.
The company plans to expand into new markets through its recent acquisition of Alere Triage assets.
Canaccord and William Blair also increased their price targets on Quidel's shares, following its acquisition of certain Alere assets and assays.
The firm said that its Panther Fusion system expands molecular testing capabilities, and increases productivity and flexibility for labs.
Researchers are working with the Australian Ministry of Health to commercialize a diagnostic test that employs the biomarker and could be available within two to five years.
The firm's Q4 global influenza sales were up 60 percent year over year, and in 2016 its global infectious disease business achieved double-digit sales growth.
The firm noted that the receipt of a CLIA waiver markedly expands the available market for use of the Sofia 2 system in detecting influenza types A and B.