NEW YORK (360Dx) — Quidel's immunoassay platform and assay for respiratory syncytial virus has been granted 510(k) approval by the US Food and Drug Administration.
The Sofia 2 is the next-generation version of Quidel's Sofia platform. It will use the same cartridges as Sofia, but offer higher- and lower-volume utilization, with an integrated barcode reader and an integrated router for Virena, the firm's remote instrument data-management system, as previously reported. The platform is also rapid, sending positive results to the cloud for Quidel's influenza test in less than three minutes, for example.
Quidel's CEO Douglas Bryant noted in a fourth quarter earnings call last month that the firm anticipates having the Sofia 2 instrument inventory needed to transition from selling Sofia to Sofia 2 in the first quarter, and that the instrument will initially run existing influenza, RSV, and Strep A cartridges, with other assays to follow.
Quidel has also filed for CLIA waiver on the Sofia 2 platform and RSV test.
In an analyst note, Nicholas Jansen of Raymond James said that he expects the new platform, along with other factors, to drive revenue growth, and an announcement on the CLIA waiver to come in the "near term."
Regarding Quidel's revenue, the platform may not drive meaningful short-term contribution, Jansen wrote, but added, "We would expect menu expansion to deliver more sizable amounts of revenue as we head into the 2017-18 flu season later this year."