DiaCarta’s ColoScape ™ test detects colorectal cancer precancerous lesions and colorectal cancer mutations with high sensitivity


Posted: October 27, 2021 at 7:00 a.m. CDT|Update: 14 minutes ago

PLEASANTON, California, October 27, 2021 / PRNewswire / – DiaCarta Inc., a precision molecular diagnostics company and a leader in the development of novel oncology tests using liquid biopsy, today announced the publication of a study on PLOS ONE Demonstrates that DiaCarta’s ColoScape ™ Xenonucleic Acid (XNA) Real-Time Quantitative Polymerase Chain Reaction (qPCR) Cross-Clamp Assay Detects Cell-Free Mutant DNA (cfDNA) from Precancerous Lesions in Colorectal Cancer (CRC) and Cancer colorectal.

The paper titled “A Novel Xenonucleic Acid-Mediated Molecular Clamping Technology for Early Detection of Colorectal Cancer” assessed the performance of the XNA-mediated qPCR clamping technology for the simultaneous and qualitative detection of somatic mutations in patients with CRC.1 Nineteen mutations in a panel of genes associated with early events in the pathogenesis of CRC are targeted in the ColoScape ™ assay.

The ColoScape ™ XNA-mediated qPCR Cross-Passage Assay is a novel multigene mutation diagnostic assay for the qualitative detection of genetic mutations associated with colorectal cancer in liquid biopsy and FFPE tissue samples. ColoScape ™ uses XNA technology, innovative synthetic xenonucleic acid molecular oligomers that hybridize to wild-type DNA target sequences. XNA oligomers act like molecular tweezers to allow precise amplification of mutant sequences only, using qPCR.

In this study, a total of 380 clinical samples, including cfDNA and FFPE plasma samples from patients with precancerous and stage RCC, were analyzed with the ColoScape ™ assay.1 With liquid biopsy, the clinical specificity of the preliminary test for CRC was 100% and the clinical sensitivity was 92.2%; for precancerous lesions, the clinical specificity was 95% and the clinical sensitivity was 62.5%.1 With FFPE samples, the clinical specificity of the preliminary test for CRC was 96% and the clinical sensitivity 92%, making this test robust, specific and very sensitive. At present, DiaCarta is conducting large ongoing clinical trials in Europe, Asia, and U.S.

“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 a 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 specimens used for the diagnosis of colorectal cancer. The sensitivity and specificity of ColoScape ™ can help detect colorectal cancer before the disease progresses to more acute stages. In addition, our new generation of ColoScape ™ assay features an XNA-powered methylation gene panel, which generates even higher sensitivity, especially for 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 are transforming patient care by providing efficient precision diagnostics using liquid biopsy. In addition to its FDA EUA approved QuantiVirus SARS-CoV-2 testing, DiaCarta offers a range of testing services, ranging from single gene QClamp® QPCR tests on its OptiSeq ™ XNA-NGS panels. The company is well positioned as a leader in the emerging field of in vitro diagnostics of “liquid biopsy” with high precision detection of ActDNA. Its new XNA technology offers a high level of sensitivity because it blocks the wild type sequence and amplifies the mutant target sequence. Using this technology, the company has developed its blood-based, early and highly sensitive ColoScape ™ colorectal cancer test. Powered by its SuperbDNA ™ technology which provides a high level of detection by amplifying the signal and requiring no RNA / DNA extraction or amplification, the company has developed its revolutionary RadTox ™ test which personalizes radiotherapy, mitigates adverse events and improves patient care. Situated at Pleasanton, California the company is ISO certified, GMP compliant, and offers its customers CLIA certified laboratory services. www.diacarta.com.

Ram Vairavan, Ph.D.,
Senior Vice President
[email protected]
+ 1760-402-6335 / + 918220318211

Olipriya Das, Ph.D.,
Russo Partners LLC
[email protected]
+1 646-942-5588

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SOURCE DiaCarta Inc.

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