RICHMOND, Calif.--(BUSINESS WIRE)--DiaCarta, the precision molecular diagnostics company, today announced it received CE-IVD approval for its innovative new colorectal cancer test, ColoScapeTM, a colorectal cancer mutation detection kit. Designed to aid colorectal cancer (CRC) diagnosis, ColoScapeTM offers high sensitivity and accuracy of detection for clinically validated CRC mutations in DNA extracted from solid tumor, plasma or stool samples.
Approved for in vitro diagnostic use in Europe, ColoScapeTM utilizes DiaCarta’s patented XNA-based clamping technology to detect 20 proprietary DNA mutation markers from 4 oncogenes with unprecedented sensitivity. Study data generated by the company and its collaborators identified greater than 95% of stage I-IV colorectal cancer cases correctly and demonstrated improved sensitivity as a pre-cancer diagnostic. ColoScapeTM can run on a variety of commonly-used real-time PCR platforms utilizing kits that leverage proprietary multiplexed TaqMan chemistry to complete the assay in less than 2.5 hours with as little as 20 ng of DNA from formalin-fixed, paraffin embedded (FFPE) tumor, plasma or stool samples.
“CE-IVD approval for ColoScapeTM 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,” said Aiguo Zhang, Ph.D., CEO of DiaCarta. “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.”
DiaCarta also announced the launch of its CE-IVD approved QFusionTM ALK Fusion Gene Detection kit. QFusionTM ALK is designed to overcome the barriers of the current “gold standard” FISH technique by detecting as low as 50 fusion templates in each single reaction.
About DiaCarta, Inc.
DiaCarta is an innovative precision molecular diagnostic company headquartered in Richmond, California. The company has an ISO 13485-certified facility, which is used to develop, manufacture and market a range of cancer research and IVD products. DiaCarta specializes in genomic testing for biomarkers and offers clinical sample testing services in a CLIA-certified laboratory. In addition, the company has a clinical service laboratory in Nanjing, China. QClamp® and OptiSeqTM are patented xeno nucleic acid (XNA) based technologies that enable highly sensitive detection of actionable mutations using qPCR and next-generation sequencing (NGS) platforms on challenging patient specimens. Other XNA applications include CRISPR/Cas9 gene-editing event screening and adapter dimer removal for NGS library preparation. To learn more, visit http://www.diacarta.com.