Paragon Genomics Files IPO Prospectus to Revolutionize Precision Medicine with CleanPlex NGS Platform

Driven by multi-stakeholder efforts in recent years, precision medicine is evolving from a popular concept in scientific research and venture capital into a healthcare service actively promoted by governments and enterprises for practical implementation, thereby benefiting the health and well-being of the general public. Notably, with its inclusion in the National Key R&D Program in March this year and the subsequent push to incorporate precision medical services into the national medical insurance reimbursement list, the key bottleneck hindering large-scale commercialization of precision medicine is expected to be broken. This development may usher in an opportunity for explosive growth across the entire industry in the coming years.

Genetic testing serves as the foundation of precision medicine. Paragon Genomics, a life sciences company from Silicon Valley, is dedicated to overcoming current bottlenecks in genetic testing, such as low accuracy and coverage, high costs, and long turnaround times in targeted sequencing. The company’s CleanPlex ultra-multiplex PCR reagent platform technology enables next-generation sequencing (NGS) targeted gene library preparation to be 5–10 times faster than existing methods on the market, while also offering greater sensitivity and accuracy.

Another distinct advantage of CleanPlex is its requirement for only 1–10 ng of input sample, which is particularly critical for samples with inherently low DNA yields, such as fine-needle aspiration biopsies and liquid biopsies. In contrast, existing technologies typically require at least 50 ng of DNA.

According to the introduction, CleanPlex technology primarily consists of three components: an ultra-high and uniform multiplex PCR reagent system, a rapid and efficient PCR background clearance technology, and highly accurate and scalable NGS panel design software. The multiplex PCR reagent system ensures that up to 4,000 DNA fragments can be uniformly amplified within a single PCR reaction tube. The PCR background clearance technology effectively and rapidly removes non-specific PCR products. The NGS panel design software enables the design and optimization of targeted sequencing panels with high efficiency, high specificity, and high uniformity for customers.

Below is a typical workflow for CleanPlex™ on Illumina sequencers:

Below is a Bioanalyzer electropherogram showing the DNA fragment quality control results for a DNA library prepared using CleanPlex, comprising 4,000 PCR reactions. The peaks labeled at 35 bp and 10,380 bp correspond to reference DNA markers. As shown in the figure, the library prepared with CleanPlex exhibits high purity with minimal background noise. This offers distinct advantages for detecting low-frequency variants, particularly in liquid biopsy applications.

Based on CleanPlex, Paragon Genomics has developed a comprehensive suite of next-generation sequencing (NGS) targeted gene library preparation solutions and products. When used in conjunction with its uniquely designed primer panels (custom or catalog panels), the CleanPlex library preparation kit offers features such as speed and simplicity, high uniformity, and high coverage. Since the primers used in CleanPlex do not require any chemical modification, their synthesis cost can be 4–6 times lower than that of other methods. The main features of CleanPlex are listed below.

• 3-Hour Simplified Workflow (Including Only 30 Minutes of Simple Manual Operations);

• Features such as high uniformity (>98%), high on-target rate (>98%), and low background noise significantly improve the accurate detection rate of variants, including low-frequency variants;

• Capable of amplifying regions that are extremely difficult to amplify (such as the TERT promoter mutation region commonly found in cancer);

• Low sample input requirement (1–10 ng), which is particularly important when sample availability is limited;

• Compatible with Illumina® sequencing platforms;

• Suitable for various sample types, including gDNA, FFPE DNA, fresh frozen tissue, and plasma cell-free DNA;

• PCR primers do not require chemical modification;

• Ultra-High Multiplex PCR Scalability: 20–4000-Plex PCR Reactions in a Single Tube.

Paragon Genomics was founded by two Chinese-American entrepreneurs, both of whom possess extensive technical and business experience in the life sciences industry. Tao Chen, Co-founder and current CEO of the company, holds an MBA from Harvard Business School and a bachelor’s degree in Chemistry from Peking University. He brings 15 years of R&D, management, and business development experience in the life sciences sector. Previously, he worked at Thermo Fisher Scientific/Life Technologies, the global leader in biological instruments and reagents, where he held leadership positions in corporate strategy and development, as well as mergers and acquisitions. He also managed a PCR biological reagents business with annual revenues of $100 million. Additionally, he has five years of drug R&D experience at Pfizer.

Liu Zhidong is another co-founder of the company and the inventor of its core technology, CleanPlex. He currently serves as the company’s President and Chief Technology Officer (CTO). Dr. Liu completed his postdoctoral fellowship at Rockefeller University, earned his Ph.D. in Molecular Genetics from the University of South Carolina, his Master’s degree from the Chinese Academy of Sciences, and his Bachelor’s degree in Virology from Wuhan University. With over 20 years of experience in gene sequencing, molecular diagnostics, and gene library preparation technologies, he previously worked at Thermo Fisher Scientific/Life Technologies and Siemens Healthineers, where he led the research and development, manufacturing, and quality control of life science reagents.

The company successfully completed its seed financing round in October 2015 and was recently selected for the California Life Sciences Association (CLSI) Spring 2016 All-Star Startup Program. It has already secured heavyweight clients such as Stanford University, the University of California, San Francisco (UCSF), and several large third-party clinical laboratories.

This July, the company will officially launch its next-generation sequencing (NGS) library preparation kits, panel design services, and a CleanPlex-based hotspot cancer panel. Leveraging CleanPlex technology and robust capabilities in targeted sequencing panel design, the company aims to become the “Android” of precision medicine. It will provide customized or off-the-shelf targeted sequencing panels and application systems to research institutions, third-party clinical laboratories, and NGS application developers, jointly tapping into a trillion-yuan market spanning non-invasive prenatal diagnosis and screening, cancer diagnostics, liquid biopsy, genetic disease testing, and personalized medication guidance.