NEW YORK (GenomeWeb) – Quidel has received 510(k) clearance from the US Food and Drug Administration for a molecular assay for the qualitative detection of Clostridium difficile.
The test runs on the firm's Solana platform and generates results in about 35 minutes from unformed stool specimens without a nucleic acid extraction step. The platform can process up to 12 different assays or patient samples in each batched run and uses the firm's helicase-dependent amplification technology, which is also the core technology of Quidel's AmpliVue molecular product line.
There were an estimated half a million C. diff infections in the US in 2011 that led to nearly 30,000 deaths.
"We are excited to introduce a Solana assay that can make a profound difference in the lives of people that are affected by [Clostridium difficile infection] through a quick and accurate diagnosis," Quidel President and CEO Douglas Bryant said in a statement.
"The laboratorian will benefit from the Solana platform's ability to address the particular workflow needs of the moderately complex laboratory setting in a cost-effective manner by neatly balancing higher volume sample testing at scale with customizable, on-demand assay processing," Bryant added.
The C. diff test is the first hospital-acquired infection assay on the Solana system, which currently has FDA-cleared tests for respiratory and sexually transmitted infections, including HSV 1+2/VZV, Complete (Strep A + C/G), Influenza A+B, and Trichomonas assays. The Solana platform was cleared by the FDA along with a Group A Strep test in 2015.