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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

"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 needed."

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.

See Also:

“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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.