At ESHG 2019 Paragon Genomics Presents Data Highlighting Accuracy, Scalability and Speed of CleanPlex® Target Enrichment Technology and Introduces CleanPlex Products for MGI Sequencers

HAYWARD, Calif., June 13, 2019 /PRNewswire/ -- Paragon Genomics, Inc., a leader in amplicon-based target enrichment and library preparation solutions for next-generation sequencing (NGS) assays, today announced the first availability of its CleanPlex^® products for use with sequencers from MGI Tech Co., Ltd. (MGI), a leading producer of high-throughput gene sequencers. Earlier this year the two companies entered into a global partnership allowing MGI to distribute CleanPlex NGS Panels optimized for use with MGI's sequencing platforms in all territories worldwide except the U.S. The MGI CleanPlex panels will be launched at the 2019 Annual Meeting of the European Society for Human Genetics (ESHG 2019), where Paragon Genomics also has multiple poster presentations and several partner exhibitor education events.

Tao Chen, co-founder and CEO of Paragon Genomics, said, "We are committed to ensuring wide access to CleanPlex, the most advanced amplicon-based NGS target enrichment technology. It enables the accurate, fast and efficient ultra-high multiplexed genomic profiling of challenging samples in a single assay. With an installed base of more than 1,100 sequencers worldwide and robust growth, MGI users represent an increasingly important segment of the NGS market. We are pleased to launch these first assays optimized for MGI sequencers less than six months after initiating our partnership and look forward to releasing additional products on an ongoing basis."

The launch of the MGI CleanPlex panels represents the first deliverable from the MGI-Paragon Genomics partnership launched in January, showing that "MGI certified assays" can work and integrate with MGI's DNBSEQ™ sequencers and workstations. "It is a great first step to build an open, inclusive and collaborative community around DNBSEQ NGS sequencing technology," said Hui Jiang, COO of MGI. 

MGI reports it has installed 1,100 of its sequencers in 16 countries and has more than 300 users. The new CleanPlex products for MGI sequencers include:

• CleanPlex for MGI Ready-to-Use NGS Panels – the CleanPlex for MGI OncoZoom Cancer Hotspot Panel and CleanPlex for MGI BRCA1 and BRCA2 Panel. Both are completely compatible with MGISEQ sequencers.

• CleanPlex for MGI Custom NGS Panels – these allow researchers to build customized assays addressing their specific needs. Paragon Genomics support staff will take custom orders and design and deliver panels that are completely compatible with MGISEQ sequencers.

• Validated automation protocols ensuring that CleanPlex for MGI assays are compatible with the MGISP-960 Automated Sample Preparation System and produce results equivalent to those from manual operation.

MGI's genetic sequencers, based on the company's proprietary DNBSEQ sequencing technology, combine the power of DNA Nanoballs (DNB™), PCR-free Rolling Circle Replication, Patterned Nano Arrays and cPAS to deliver a new level of data clarity and affordability.

MGISP-960 High-throughput Automated Sample Preparation System is a flexible, fully automated workstation with a built-in NGS sample-prep process and tailored workflows to satisfy the unique needs of individual labs. MGIFLP is a modular NGS workstation that integrates the entire NGS process into one step and provides clinical personnel and researchers a fully automated solution, from sample to sequencing report. These automation solutions enable MGI's customers to optimize their NGS workflows, even with their own assays. 

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. CleanPlex NGS Panels are available for use with Illumina, Ion Torrent and MGI sequencing platforms.

At ESHG 2019, Paragon Genomics' researchers are presenting three posters.

The first poster¹ describes how the amplicon-based CleanPlex Hereditary Cancer Panel replaces the current tedious, laborious and error-plagued hybrid-capture-based sequencing approach with high-quality genomic coverage using a fast, simple, and streamlined NGS library preparation workflow that rapidly and accurately profiles cancer risks with very small DNA inputs. The assay is highly reproducible and sensitive, with an R2 value of 0.95 between independently prepared replicates, and a detection rate of >99% for single nucleotide variants.

A second poster² demonstrates the utility of CleanPlex NGS technology for rapid tumor mutation burden (TMB) profiling. It shows that CleanPlex technology is capable of creating high quality amplicon libraries with high uniformity, low GC bias and sensitive variant calling, even for ultra-multiplexed libraries. The prototype CleanPlex panel for TMB produced excellent performance metrics for about 20,000 amplicons covering 355 genes, using a simple workflow that required less than 4 hours to complete. It exhibited >95% uniformity at 0.2X mean, limited GC bias and >94% detection rate for mutants with 5% allele frequencies.

The third poster³ shows how CleanPlex UMI technology used in liquid biopsy applications demonstrates high sensitivity with low false positive rates for the detection of low-frequency alleles, even at low DNA inputs. It has a simple, cost-effective workflow. Liquid biopsy presents challenges as low fractions of mutant DNA can be masked by artifacts or background noise, leading to false negatives. The CleanPlex UMI Lung Cancer Panel using an input of just 50ng of cell-free DNA detected nearly all mutations at 0.1% minor allele frequency (mAF) and at 0.25% mAF with 100% positive predictive value (PPV).

CleanPlex will be discussed at two ESHG 2019 satellite events hosted by Paragon Genomics' partners:

• MGI is hosting a Corporate Satellite session entitled "Towards a Perfect Genome", which includes a discussion of CleanPlex technology:
• Saturday, June 15, 2019, 10:00-11:30 am
• Room A-3 Svenska, Mässan Gothia Towers
• Presentation: CleanPlex for MGI: A New Targeted NGS Solution with Exceptional Coverage, Uniformity and Rapid Customization
• Speaker: Edward Jan, PhD, Director of Product Marketing, Paragon Genomics, Inc.

• SOPHiA GENETICS is hosting a Corporate Satellite session entitled "Hereditary Disorders Solutions Powered by SOPHiA: Overcoming Challenges to Increase Diagnostic Yield", which includes a discussion of CleanPlex technology:
• Sunday, June 16, 2019, 3:00-4:30 pm
• Room A-1 Svenska, Mässan Gothia Towers
• Presentation: Molecular profiling of osteogenesis imperfecta through a targeted gene panel powered by SOPHiA (CleanPlex custom NGS panel)
• Speaker: Associate Professor Sehime Gülsün Temel, MD, PhD, Department of Medical Genetics, Uludag University Hospital, Turkey

1 – ESHG Poster Program #338: Determining genetic predispositions using CleanPlex^® Hereditary Cancer Panel for a rapid and streamlined amplicon-based NGS workflow, Posters P15, June 17, 4:45-5:45 pm
2 – ESHG Poster Program #337: Ultra-high multiplexed 20,000-amplicon NGS panel for tumor mutational burden (TMB) analysis using a rapid 4-hour workflow, Posters P12, June 17, 10:15-11:15 am
3 – ESHG Poster Program #342: Variant detection with an ultra-multiplexed 20,000-amplicon CleanPlex^® NGS panel, Posters P16, June 17, 10:15-11:15 am.

Paragon Genomics' CleanPlex^® products are for Research Use Only.

About Paragon Genomics
Paragon Genomics (paragongenomics.com) is a leader in amplicon-based target enrichment and library preparation solutions to accelerate the development of next-generation sequencing (NGS)-based assays for research and clinical testing. The company designs high performance and ultra-multiplexed amplicon NGS panels and develops NGS library preparation chemistries for analyzing difficult, clinically-relevant samples. It strives to make the design of custom NGS assays easily available to a broad range of users, with expert counsel and rapid turnaround. Privately-held Paragon Genomics is located in Hayward, California. 

About MGI
MGI Tech Co., Ltd. (MGI), a subsidiary of BGI Group, is committed to enabling effective and affordable healthcare solutions for all. Based on its proprietary technology, MGI produces sequencing devices, equipment, consumables and reagents to support life science research, medicine and healthcare. MGI's multi-omics platforms include genetic sequencing, mass spectrometry and medical imaging. Providing real-time, comprehensive, life-long solutions, its mission is to develop and promote advanced life science tools for future healthcare. For more information, visit en.mgitech.cn/.

SOURCE Paragon Genomics, Inc.

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