DiaCarta's ColoScape™ Assay Detects Precancerous Colorectal Cancer Lesions and Colorectal Cancer Mutations with High Sensitivity

Published: Oct. 27, 2021 at 7:00 AM CDT

PLEASANTON, Calif., Oct. 27, 2021 /PRNewswire/ -- DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy, today announced the publication of a study in PLOS ONE that demonstrates that DiaCarta's ColoScape™ Xenonucleic Acid (XNA)-mediated quantitative real-time polymerase chain reactions (qPCR) clamping assay detects mutant cell-free DNA (cfDNA) from precancerous colorectal cancer (CRC) lesions and colorectal cancer.

The paper entitled, "A novel xenonucleic acid-mediated molecular clamping technology for early colorectal cancer screening," evaluated the performance of XNA-mediated qPCR clamping technology for the simultaneous and qualitative detection of somatic mutations in CRC patients.1 Nineteen mutations in a panel of genes associated with early events in CRC pathogenesis are targeted in the ColoScape™ assay.

The ColoScape™ XNA-mediated qPCR clamping assay is a novel multi-gene mutation diagnostic assay for the qualitative detection of colorectal cancer-associated gene mutations in liquid biopsy and FFPE tissue samples. ColoScape™ utilizes XNA technology, innovative synthetic Xenonucleic acid molecular oligomers that hybridize with target wild-type DNA sequences. The XNA oligomers act as molecular clamps to enable the accurate amplification of mutant sequences only, using qPCR.

In this study, a total of 380 clinical samples, including plasma cfDNA and FFPE samples from patients with precancerous and different stages of CRC, were analyzed with the ColoScape™ assay.1 With liquid biopsy the preliminary assay clinical specificity for CRC was 100% and the clinical sensitivity was 92.2%; for precancerous lesions clinical specificity was 95% and clinical sensitivity was 62.5%.1  With FFPE samples the preliminary assay clinical specificity for CRC was 96% and the clinical sensitivity was 92%, making this assay robust, specific and highly sensitive. Currently, DiaCarta has large clinical trials ongoing in Europe, Asia, and US.

"This study validates the diagnostic application of the ColoScape™ assay in the early detection of precancerous lesions and colorectal cancer based on the amplification and detection of cfDNA mutants from one tube of blood," said Aiguo (Adam) Zhang, Ph.D., CEO, DiaCarta, Inc. "Our technology has the potential to disrupt the standard method of FFPE or stool samples used for the diagnosis of colorectal cancer. ColoScape™'s sensitivity and specificity may yield detection of colorectal cancer before the disease progresses to more acute stages. In addition, our new generation of ColoScape™ test includes a panel of methylation genes powered by XNA, which generates even higher sensitivity, especially for the precancerous lesions."

1 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0244332

About DiaCarta Inc.  
DiaCarta is a molecular diagnostics company that has developed innovative technologies that transform patient care by providing effective precision diagnostics using liquid biopsy. In addition to its FDA EUA approved QuantiVirus SARS-CoV-2 Tests, DiaCarta offers a range of testing services, from single-gene QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. The company is well positioned as a leader in the new 'liquid biopsy' In Vitro Diagnostics field with high-precision detection of ctDNA. Its novel XNA technology provides high level of sensitivity as it clamps the wild-type sequence and amplifies the mutant target sequence. Using this technology, the company has developed its highly sensitive, early detection ColoScape™ Colorectal Cancer test using blood. Powered by its SuperbDNA™ technology that provides high level of detection by amplifying the signal and requiring no RNA/DNA extraction or amplification, the company has developed its revolutionary RadTox™ test that personalizes radiation therapy, mitigates adverse events, and enhances patient care. Based in Pleasanton, California the company is ISO certified, GMP-compliant and offers CLIA certified laboratory services to its customers. www.diacarta.com.

Ram Vairavan, Ph.D.,  
Senior Vice President    

Olipriya Das, Ph.D.,   
Russo Partners LLC 

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SOURCE DiaCarta Inc.

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