NEW YORK (GenomeWeb News) – Prodesse announced after the close of the market Thursday that the US Food and Drug Administration has cleared for marketing the firm's ProGastro Cd Assay.
The real-time PCR assay detects toxigenic strains of Clostridium difficile, a healthcare-associated infection that affects around 500,000 patients in the US annually. The test provides results in as little as three hours, said Prodesse.
The Milwaukee, Wis.-based firm said that in clinical studies its molecular assay detected 43 percent more positives than the current gold standard for testing, the cell cytotoxin assay. It added that genetic sequencing confirmed that more than 90 percent of the additional positives its test detected were accurate.
"Even though we expected this was going to be a large market when we made the decision to develop a C. diff assay, we’ve been surprised by the intensity of interest from laboratories that want to perform evaluations," Prodesse CEO Tom Shannon said in a statement. "With this clearance, we expect to increase our customer base very substantially."
Earlier this year, Becton Dickinson received FDA clearance to market its C. difficile molecular diagnostic assay in the US.