New CleanPlex CFTR panel and fusion detection methods unveiled

Paragon Genomics, Inc., has announced two new products at the 2019 Association for Molecular Pathology (AMP) Annual Meeting & Expo; a CleanPlex^® CFTR Panel for cystic fibrosis and CleanPlex Fusion Detection Methods for the diagnostic and prognostic assessment of cancer tumor progression.

The CFTR Panel leverages Paragon Genomics' CleanPlex technology in a multiplex PCR-based targeted resequencing assay designed to simplify the evaluation of somatic and germline variants across the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. Mutations in this gene cause the devastating disease cystic fibrosis, and more than 1700 mutations have been identified to date. Different mutations affect the functioning of the CFTR gene in different ways, so a comprehensive assessment is essential for determining optimal treatment. The CleanPlex CFTR Panel covers all exons of the CFTR gene and includes the important American College of Medical Genetics (ACMG)-recommended mutations, in a rapid and easy-to-use format.

Paragon Genomics also announced early access to its CleanPlex Fusion Detection Methods for known and novel gene fusions. At present, scientists have identified more than 21,000 gene fusions in almost all main subtypes of human cancers. Fusion genes, which often are oncogenes, contribute to tumor formation. The identification of fusion genes can serve as diagnostic and prognostic markers of tumor progression. The CleanPlex Fusion Detection Methods are built upon Paragon Genomics’ key ultra-high multiplex PCR and PCR background cleaning technologies, enabling the detection of fusion genes with or without known breakpoints in a rapid and easy-to-use format. Early access to the first panel, a Lung Cancer Fusion Panel, is now open, and the company will start to provide additional panel products along with a custom fusion assay design service towards the end of this year.

The utility of its CleanPlex TMB Panel, an ultra-high multiplexed amplicon-based NGS target enrichment approach for accurate, rapid and comprehensive TMB profiling, covering all the exons of 500 genes in a robust assay. Paragon Genomics’ collaborator, RareCyte, facilitates the CleanPlex technology’s targeted sequencing of single circulating cancer cells retrieved.

Tao Chen, CEO of Paragon Genomics, commented, “It’s gratifying to participate in a major industry event like AMP 2019 with important new products for our growing customer base. Our CleanPlex technology has the potential to make NGS-based genomic analyses across a wide variety of applications faster, easier, more accurate, more economical and more feasible. We look forward to sharing our latest advances with customers and colleagues in the coming days.”

Paragon Genomics' CleanPlex is a proprietary, ultra-high multiplexed NGS target enrichment technology featuring an innovative PCR background cleaning chemistry that allows tens of thousands of amplicons to be multiplexed in a single reaction pool, allowing a large number of targets to be interrogated in a single assay. The CleanPlex technology is available as ready-to-use panels or as customized assays designed and optimized using the company’s advanced panel design algorithm.

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