Quidel Receives FDA Clearance for Solana(R) Strep Complete Assay

Quidel has received 510(k) clearance from the FDA to market Quidel's new Solana Strep Complete Assay for the rapid and qualitative detection and differentiation of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus) nucleic acids isolated from throat swab specimens obtained from symptomatic patients.

The Solana molecular platform leverages the Helicase-Dependent Amplification technology in Quidel's AmpliVue molecular product line to generate a fast and accurate test result.

The device can process up to 12 patient samples in each 25-minute run. — Cynthia Jessup