ChromaCode Announces Publication Highlighting Advancements in HDPCR NSCLC Assay Performance, Demonstrating Advantages Over Next Generation Sequencing in Enabling Timely Results, and as a Vital 'Rescue' Solution when NGS is not Viable

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Nov 14, 2023, 08:00 ET

CARLSBAD, Calif., Nov. 14, 2023 /PRNewswire/ -- ChromaCode, Inc., a pioneering genomics multiplexing platform company developing accessible and affordable laboratory-based solutions, today announced the publication of a study demonstrating the performance of its HDPCR technology-based assay for non-small cell lung cancer (NSCLC). The paper, titled "Analytical Performance and Concordance with Next-Generation Sequencing of a Rapid, Multiplexed dPCR Panel for the Detection of DNA and RNA Biomarkers in Non-Small-Cell Lung Cancer" is now available in the journal Diagnostics.

"We are very pleased with the results of this scientific study which demonstrates the utility of the NSCLC assay as an efficient and cost-effective frontline tool to benefit lung cancer patients. Fifty percent of the NSCLC population does not receive comprehensive biomarker testing due to technical obstacles such as low sample input, long-turnaround times, and/or complex workflows that may be challenging to implement locally in community settings," said Mark McDonough, CEO of ChromaCode. "We are enthusiastic about our HDPCR assay as an upfront, viable option to complement more expensive methods such as next-generation sequencing (NGS), especially in cases where time is critical or limited input material from core biopsies may otherwise result in NGS failure or missed variant calls. While NSCLC is the poster child for "rescue" with an estimated 22% of patients not having enough sample for molecular testing, the utility extends beyond NSCLC, including gliomas, cholangiocarcinomas, thyroid and other cancers when biopsy or ctDNA specimens are limited."

The HDPCR NSCLC assay, designed to have best-in-class coverage of genes identified by the National Comprehensive Cancer Network (NCCN) as clinically relevant in NSCLC, features a workflow delivering sample to results within 24 hours. In this newly published research, the NSCLC assay demonstrated remarkable sensitivity, even with minimal input material obtained from formalin-fixed paraffin-embedded (FFPE) tissue samples. Covering hundreds of variants across the nine genes recommended by the NCCN for biomarker testing, the assay comprehensively detects single nucleotide variants, insertions, and deletions in DNA, as well as RNA fusions within a single and efficient workflow. This technology addresses key challenges in NSCLC diagnosis and treatment by offering rapid biomarker testing with minimal input, making it an ideal choice for laboratories worldwide.

Key findings of the study include:

The assay showed high sensitivity, with the lowest percentage of mutant alleles in the sample (mutant allele fraction) that was consistently detectable ranging between 0.8% and 4.9% (Limit of Detection or LOD) when utilizing 20 ng of DNA input. At 5 ng, the LOD for RNA targets ranged from 23 to 101 counts.
The assay achieved 99% coverage of NSCLC somatic variants found in the COSMIC Mutation Database including 89-100% overall inclusivity of clinically relevant indels (EGFR Exon 19 deletions at 99.5%), and RNA fusions (95–100%).
The concordance of the HDPCR NSCLC panel with the comparator method was 97.3%.
78% of discordant results were resolved in favor of the HDPCR assay.

About ChromaCode

ChromaCode is an innovator in genomics multiplexing platform technology, providing laboratory solutions with its proven HDPCR^™ technology. HDPCR^™ is a revolutionary approach allowing for deep multiplexing of biomarkers in a single, rapid, cost-effective assay for multiple sample types on standard laboratory dPCR platforms. This adaptable technology, deployed with ChromaCode's cloud-based analysis, enables laboratories worldwide to affordably conduct testing internally and produce high quality results with demonstrated high concordance with next generation sequencing (NGS) based testing, increasing accessibility of diagnostics with a cost effective and scalable solution. For more information visit ChromaCode.com or find us on LinkedIn and Twitter.

Media Contact - ChromaCode

David Schull
Russo Partners
858-717-2310
david.schull@russopartnersllc.com

SOURCE ChromaCode, Inc.