The European Union has granted CE mark to Abacus Diagnostica's molecular diagnostic assay, designed for detecting toxin-producing Clostridium difficile.
The GenomEra C. difficile assay, which is designed for use with the company’s GenomEra CDX system, combines minimal sample preparation with polymerase chain reaction (PCR ) amplification and end-point detection for fully integrated and automated nucleic acid analysis.
Using the target amplification and end-point detection technology, the assay uses the stool sample for analysis and provides test results in 50 minutes.
Abacus Diagnostica CEO Tom Palenius said the company is committed to provide a continuum of diagnostic products for infectious diseases to meet the needs of various laboratory settings.
"Along with our earlier CE marked MRSA/SA assays this PCR test will help to meet the testing and resource challenges of many different types of labs," Palenius added.
"During next year we will continue to expand our molecular test offering for critical blood stream and perinatal infections."