AccuraGen Launches AccuCon™ Kit in Suzhou, Marking Strategic Shift from Service to Product-Centric Business Model

2017Year12MonthOn the 6th, Suzhou Ankeji Biotechnology Co., Ltd. held the “Ankekang™Launch Ceremony of the Test Kit", Suzhou Industrial ParkAll LevelsLeader、EnterpriseRepresentativeAttended the launch ceremony.

In recent years, China’s genetic testing industry has experienced healthy development, with the market for clinical oncology testing showing particularly strong potential. Among these advancements, ctDNA-NGS based on liquid biopsy has become a focal point of interest for clinicians, laboratory medicine professionals, and investors alike.

However, behind the industry’s booming growth lie unresolved challenges: varying technical capabilities among practitioners, a lack of standardized norms for next-generation sequencing (NGS) testing, and increasingly intense homogeneous competition.

In the face of a landscape marked by both opportunities and challenges, Ankeji has made a strategic decision to transform its ctDNA-NGS testing services from a business model dominated by third-party reference laboratory outsourcing into kit-based products. Ankeji aims to democratize the complex and cumbersome ctDNA-NGS technology, enabling more clinical medical laboratories to access it and independently carry out clinical applications of ctDNA according to their specific needs.

Following the completion of its Series B financing in 2016, AnchorJi Group established Suzhou AnchorJi Biotechnology Co., Ltd. to align with this strategic pivot. During the same period, a state-of-the-art, high-cleanliness production facility spanning nearly 2,200 square meters was built. This facility includes dedicated production workshops for test kits, positive controls, and negative controls, as well as an independent quality control laboratory. It is equipped with comprehensive production equipment and precision analytical instruments, such as digital PCR systems and the MiseqDx.

The Suzhou-based company specializes in manufacturing high-standard kits required for clinical medical laboratories and research institutions to conduct in-house ctDNA-NGS testing.This Ankekang™ The launch of the kit product marks a milestone in the company’s strategic transformation from a service-oriented enterprise to a product-oriented enterprise.

Since its establishment, Suzhou AnchorJi has received significant attention and support from the leadership of the Suzhou Industrial Park. In the 11th Suzhou Industrial Park Science and Technology Leading Talent Innovation and Entrepreneurship Project selection, initiated by the Administrative Committee of Suzhou Industrial Park, AnchorJi Group’s AncoKang™ kit / “Research, Development, and Industrialization of Tumor Cell-Free DNA Gene Mutation Detection Kit (High-Throughput Sequencing Method)” project stood out among hundreds of high-tech projects in the park, winning the highest honor of “Major Leading Project.”

“Major Leading Projects” are awarded to sci-tech projects within the park that demonstrate international leadership in technical proficiency, achieve significant breakthroughs in their respective fields, and can realize industrialization within one to two years. Among the nine recipients of the “Major Leading Projects” award, Ankeji is the only genetic testing enterprise.

Leveraging Anchors’ proprietary Firefly™ patented technology featuring “single-strand circularization and tandem error correction,” along with the Illumina MiSeq® platform, the AnkeKang™ kit achieves an analytical sensitivity of 0.1% and single-base specificity of 99.9999%. The product enables simplified detection of cell-free DNA from plasma, making it suitable for implementation in medium- and large-sized hospitals.

The initial batch of test kits primarily focuses on mutation sites such as EGFR, KRAS, BRAF, ALK, and PIK3CA covered in the guidelines for lung cancer and colorectal cancer. They are mainly used to detect single nucleotide variants (SNVs), insertions and deletions (InDels), and fusion mutations in mandatory testing genes.

Unlike conventional amplicon sequencing, this kit can detect not only common hotspot mutations in these genes but also those within the region.de novoMutation. More importantly, the kit has undergone multiple rounds of testing at various types of testing institutions (such as hospital technical departments and third-party clinical laboratories), ensuring operational stability and reproducibility under high-performance conditions.

Compared with traditional ctDNA-NGS testing technologies, the AnkeKang™ kit provides a one-stop solution covering target enrichment, library preparation, data analysis, and report generation. The entire process takes only 4–5 working days and can be performed by as few as two personnel holding PCR operation certificates.

The data analysis process is handled via cloud services, essentially achieving fully automated, unattended operation—including automatic data upload, analysis, report generation, and local download—making it suitable for routine genetic testing aligned with clinical guidelines.

While most domestic NGS companies are currently focusing on submitting their tissue sequencing kits for CFDA approval, Ankeji, as a company dedicated to non-invasive ctDNA testing, will advance the application for a CFDA medical device license for its Ankekang™ kit.

Currently, a common component in the Ankeji kit has obtained Class I in vitro diagnostic reagent filing.

As a technology-driven enterprise, Ancare positions itself as a producer of lean, high-quality products. The company is actively seeking strategic marketing partners to foster industrial development through an “ecosystem of mutual benefit and win-win outcomes.” With an open approach, Ancare will make its products available to medical testing laboratories, including third-party clinical laboratories, and provide the most comprehensive pre-sales and after-sales support.

At the launch ceremony, Ankeji signed a strategic commercial cooperation agreement with Shanghai Yihua Biotechnology Co., Ltd. As Illumina’s authorized distributor in the Shanghai region, Yihua Biotechnology is an experienced enterprise specializing in the marketing of IVD and molecular diagnostic products. This agreement establishes Shanghai Yihua as a commercial partner of Ankeji, and the two parties will collaborate to promote the commercialization of Anke Kang™ in medical laboratories across the Shanghai region.

Prior to the launch ceremony of AncorCon™, AnchorJi had already engaged in clinical research collaborations on ctDNA-NGS and kit performance testing with more than 20 major Grade IIIA hospitals, including Peking University Cancer Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences, Shanghai Chest Hospital, and Zhongshan Hospital Fudan University.

Within just one year, Ankeji successfully transitioned from offering first-class ctDNA-NGS technology to providing first-class ctDNA-NGS kits. Ankekang™ has also become the third commercially available kit on the Chinese market, following Roche Diagnostics’ Avenio and Thermo Fisher Scientific’s Oncomine.

It is reported that AccuGen has now launched the Accu-Kit™ Demo Test program. Any medical laboratory equipped with an Illumina MiSeq® sequencing platform and staffed with personnel capable of performing basic molecular diagnostics operations may apply to AccuGen for a trial of the Accu-Kit™ reagent kit.