TEST:

HDPCR NSCLC RUO Assay

"ChromaCode, Inc...announced a partnership with Department of Pathology, Medical College of Georgia, to test the analytical and clinical performance of ChromaCode's HDPCR non-small cell lung cancer (NSCLC) biomarker assay....Department of Pathology, Medical College of Georgia will continue the validation process to establish the analytical and clinical performance of the NSCLC kit."

"ChromaCode, Inc., a pioneering genomics multiplexing platform company developing accessible and affordable laboratory-based solutions, today announced the publication of a study...in the journal Diagnostics...Key findings of the study include: While NGS had up to an 86% loss in sensitivity as contrived sample inputs were serially diluted, the HDPCR NSCLC Panel showed high sensitivity and specificity in diluted low-input samples that ranged from 40 to 1 ng DNA and from 20 to 2.5 ng RNA....The HDPCR NSCLC Panel was able to detect variants below input requirements for NGS with accurate results down to 10 ng DNA and 7.5 ng RNA. Importantly the test detected variants missed by NGS at these lower levels."

"ChromaCode...announced the signing of an early access agreement with Tennessee Oncology, a nationally recognized oncology practice with 35 clinical sites of care across Tennessee and in Northwest Georgia, to test the analytical and clinical performance of ChromaCode's HDPCR non-small cell lung cancer (NSCLC) biomarker assay. The NSCLC assay has complete coverage of variants identified by the National Comprehensive Cancer Network (NCCN) as clinically relevant in NSCLC and offers a streamlined workflow for rapid results, even with low sample input, while decentralizing molecular testing through cloud-based analysis....Tennessee Oncology will perform further studies to validate the analytical and clinical performance of the NSCLC kit."

"ChromaCode...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 have shown that the HDPCR NSCLC Panel provides timely, comprehensive, and sensitive mutation detection in NSCLC samples with results in less than 24 hours."

"ChromaCode, Inc...will present new data during a Corporate workshop and present two accepted scientific abstracts at the Association for Molecular Pathology (AMP) 2023 annual meeting, being held at the Salt Palace Convention Center in Salt Lake City, Utah, from November 14-18, 2023....Our accepted scientific abstracts demonstrate the excellent performance of the HDPCR technology in solid and heme malignancies. At the Corporate Workshop, we will be revealing new data showcasing the potential of HDPCR enabled multiplexing and ChromaCode software in transplant and minimal residual disease."

"ChromaCode...announce the publication of the first peer-reviewed demonstration of non-small-cell lung cancer (NSCLC) variant detection using ChromaCode’s groundbreaking High Definition PCR (HDPCR™) technology. The paper, titled 'A rapid, multiplex digital PCR assay to detect gene variants and fusions in non-small cell lung cancer,' is now available in the open-access journal Molecular Oncology."

"ChromaCode, Inc....today announced a strategic partnership with Protean BioDiagnostics Inc...This partnership's goal is to introduce a non-small cell lung cancer (NSCLC) assay, based on ChromaCode's state-of-the-art High Definition PCR (HDPCR™) multiplexing technology, via an early access program....The ultimate goal of the strategic partnership between ChromaCode and Protean is to extend the benefits of affordable and easily accessible assays that ensure rapid and precise diagnoses to a diverse range of patients in both Florida and the rest of the USA."

"ChromaCode...announced an early-access commercial launch of a non-small-cell lung cancer assay based on innovative High Definition PCR (HDPCR™) technology. Non-small-cell lung cancer (NSCLC) is the most common cancer of the lung, accounting for approximately 85% of the more than 230,000 lung cancer diagnoses in the United States each year, and has a five-year survival rate of only 25.4 %, according to the National Cancer Institute."

"ChromaCode...announced today a partnership with MedGenome, to bring its innovative High Definition PCR (HDPCR™) multiplexing technology to India and the Middle East. With the size of the Indian genomics market estimated to reach $2.7 billion by 2023, there is an unmet need for advanced yet affordable molecular diagnostics solutions that can reach a broader population."