US-based molecular diagnostics company DiaCarta has secured CE-IVD approval for its new mutation detection kit ColoScape, for the diagnosis of colorectal cancer (CRC).
Currently approved for in-vitro diagnostic use in Europe, ColoScape is claimed to have a high-sensitivity and accuracy to identify clinically validated CRC mutations in DNA extracted from solid tumour, plasma or stool samples.
Equipped with the company's patented XNA-based clamping technology, ColoScape can detect 20 proprietary DNA mutation markers from four oncogenes.
It can run on different real-time PCR platform utilising kits that work with proprietary multiplexed TaqMan chemistry to perform the assay with 20ng of DNA from formalin-fixed, paraffin embedded (FFPE) tumour, plasma or stool samples, within 2.5 hours.
DiaCarta chief executive officer Aiguo Zhang said: “CE-IVD approval for 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.
“This is an innovative product application from our flagship QClamp XNA technology platform. 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.”
The results from a study conducted by the company showed that ColoScape has correctly detected stage I-IV colorectal cancers in more than 95% of the cases, as well as indicated increased sensitivity as a pre-cancer diagnostic.
DiaCarta has launched its CE-IVD approved QFusion ALK Fusion gene detection kit to identify fusion templates in each single reaction.