NEW YORK (GenomeWeb) – Molecular diagnostics firm DiaCarta said yesterday it has received CE-IVD marking for its PCR-based kit to detect mutations associated with colorectal cancer.
The ColoScape test uses DiaCarta's QClamp XNA-based clamping technology and runs on commonly-used real-time PCR platforms in two-and-a-half hours. It requires as little as 20 ng of DNA from formalin-fixed, paraffin embedded tumor, stool, or plasma samples, and it detects 20 DNA mutation markers from four oncogenes, the firm said in a statement.
Study data generated by the company and its collaborators using the kit showed it identified greater than 95 percent of stage I-IV colorectal cancer cases, DiaCarta said.
"CE-IVD approval for the ColoScape kit means we can offer clinicians the ability to screen for CRC mutations from patient samples with the highest level of performance that the clinical setting demands," CEO of DiaCarta, Aiguo Zhang, said. "Our goal is to expand the global reach of this best-in-class clinical product with additional regulatory filings planned later this year and into 2018"
Additionally, the Richmond, California-based firm announced it has launched a CE-marked assay for ALK fusions, the QFusion ALK Fusion Gene Detection kit, which can detect as few as 50 fusion templates in a single reaction.