HeliTec Genomics Secures Tens of Millions in Funding and Launches Strategic Partnership with ArcherDx

Recently, the concepts of panel testing and liquid biopsy have once again gained significant momentum. In China, BGI Genomics and Berry Oncology are still fiercely competing for the title of the first publicly listed gene testing company. Zhenhe Technology announced that it had secured RMB 128 million in Series B financing, led by Tsinghua Holdings’ Yinxing Capital. Aiji Taikang announced the completion of RMB 50 million in financing from Zhongguancun Development Group. Internationally, GRAIL raised a substantial $900 million in the initial closing of its Series B round.

On March 4, Shenzhen Hengte Gene announced that the company obtained in October 2016Secured RMB 10 Million in Angel Financing from Shenzhen Qianjing Investment. It is reported that the company's next round of financing is currently underway.

Hengte Gene was founded in May 2016. Its core team comprises experts with extensive experience in cancer genetic testing and precision medicine, as well as senior executives from the pharmaceutical industry, hailing from prestigious institutions such as Harvard Medical School, Massachusetts General Hospital, and the Karolinska Institutet in Sweden. Leveraging next-generation high-throughput sequencing platforms, the company primarily provides sensitive and reliable genetic testing products and services for early tumor screening and precision cancer treatment.

In the early detection market, Hengte Gene’s PANO-Seq panoramic sequencing technology holds an internationally leading position in the field of ctDNA testing. By targeting 69 high-incidence cancer-related genes—including oncogenes, tumor suppressor genes, cancer biomarkers, and signaling receptors—it enables comprehensive detection suitable for various solid tumors (lung cancer, pancreatic cancer, colorectal cancer, esophageal cancer, and breast cancer). Its innovations include the pioneering integration of DNA and RNA into a single reaction tube for library preparation, which effectively reduces total processing time, eliminates the need to pre-identify gene fusion partners, and avoids repetitive testing.

Dr. Zheng Zongli, Co-founder and Chief Scientist of Hengte Gene, earned his Ph.D. from the Karolinska Institutet in Sweden and completed his postdoctoral fellowship at the Cancer Center of Massachusetts General Hospital (MGH), Harvard Medical School. During his tenure at MGH, Dr. Zheng invented Anchored Multiplex PCR (AMP). This technology underwent clinical validation in over 10,000 cases across three years for molecular cancer diagnostics at MGH. Due to its high efficiency, sensitivity, and specificity, AMP has replaced other methods to become the sole molecular pathology testing platform within the hospital and was granted a U.S. patent in November 2016.

As early as 2013, the patent was exclusively licensed to ArcherDx, a U.S.-based startup that has since become a prominent high-throughput sequencing company in the United States. Sequencing products developed by ArcherDx on its AMP technology platform have rapidly gained widespread adoption across the U.S. due to their reliable performance and superior metrics. These products are extensively utilized in cancer molecular diagnostics at leading institutions such as Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, and the third-party medical testing laboratory LabCorp. Furthermore, compatibility with both Illumina and Thermo Fisher sequencing platforms has propelled ArcherDx to become one of the most capable specialized NGS molecular diagnostic companies in the U.S., with its products widely applied in scientific research, pathological testing, and tumor diagnosis and treatment.

In addition to early detection, another key focus of cancer prevention and treatment is precision therapy, a field in which ArcherDX’s products are internationally leading. On March 4, Hengte Gene also announced that it had signed a strategic cooperation agreement with ArcherDX, a renowned U.S.-based next-generation sequencing (NGS) company, on January 17, 2017. Under the agreement, Hengte Gene will be responsible for business development and brand promotion of all ArcherDX products in the Chinese market, as well as for handling the registration of ArcherDX products as in vitro diagnostic (IVD) devices with the China Food and Drug Administration (CFDA). The two parties have also engaged in in-depth discussions regarding cross-licensing of their respective patented intellectual property rights, with plans to initiate this process at an appropriate time.

In September 2013, just nine months after its founding, ArcherDx was acquired by Enzymatics for $50 million. The most valued core asset was ArcherDx’s cancer treatment assessment software. At that time, Jason Myers, the founder of ArcherDx, along with his bioinformatics team, also joined Enzymatics to help develop next-generation sequencing technologies.

In May 2016, ArcherDx and the gene sequencing giant Illumina announced a partnership to jointly develop next-generation sequencing (NGS)-based companion diagnostic products. According to the agreement, ArcherDx will leverage its multiplex PCR chemistry platform (AMP) to develop assay kits, which will be run on Illumina’s MiSeqDx platform.

Jason Myers, founder of ArcherDx, stated at the time that this collaboration with Illumina would create a new legacy test for next-generation targeted therapies and would involve partnering with pharmaceutical companies to develop an NGS-based companion diagnostic test capable of gaining FDA approval. It is reported that most currently approved companion diagnostic products are based on PCR or FISH platforms. It was not until December 2016, when the FDA approved Foundation Medicine’s FoundationFocus CDxBRCA for market launch to help identify ovarian cancer patients most likely to benefit from Clovis Oncology’s new drug Rubraca, that the first NGS-based companion diagnostic solution received FDA approval.

According to the FDA definition, a companion diagnostic is a medical device, often an in vitro diagnostic (IVD) device, that provides information essential for the safe and effective use of a specific drug or biological product. Currently, it has garnered significant attention due to the surge in precision medicine and is widely adopted by oncologists for its integration with personalized therapy. According to Visiongain’s forecasts, the global market for companion diagnostics and diagnostic testing services was valued at $11.4 billion by 2021, with a compound annual growth rate (CAGR) of 22% over five years.

and in2017Year1Month20On that day, Hengte Gene also signed a cooperation agreement with the Zhongshan Institute of Oncology to jointly carry out aNGSA Large-Scale Cohort Study on Liquid Biopsy for Cancer Screening in High-Risk Populations.

Signing Ceremony between Zhou Dongbin, General Manager of Hengte Gene, and Ji Mingfang, Deputy Director of Zhongshan People's Hospital and Zhongshan Institute of Oncology

Zhongshan Cancer Institute is a national base for early diagnosis and treatment of cancer in China, and the first domestic site for comprehensive cancer prevention and control. It has achieved outstanding performance in the early diagnosis and treatment of various malignant tumors, automated cancer registration, and comprehensive cancer therapy, and has undertaken multiple national scientific research projects. Notably, its cancer registration work has reached an internationally advanced level. By tracking and recording high-risk populations over many years, the institute has established a large-scale continuous follow-up sample bank for high-risk groups, laying a solid foundation for conducting large-scale cohort studies.

This collaboration is based on Hengte Gene’s independently developed, proprietary tumor ctDNA liquid biopsy technology (PANO-Seq™). Leveraging its stability, reliability, high sensitivity, and high specificity, the partnership will conduct a cohort study of tumor ctDNA testing using the large-scale high-risk population sample bank collected by the Zhongshan City Institute of Cancer Research.

Dr. Chen Li, Chief Technology Officer at Hengte Gene, stated that this large-scale cohort study represents a world-leading research initiative. What distinguishes it from other ctDNA studies is its enrollment of over 10,000 high-risk individuals, who have been continuously monitored for five years. Given that ctDNA levels in the blood of these subjects undergo continuous changes, integrating the longitudinal liquid biopsy results with periodic clinical diagnoses enables robust analytical insights. This approach provides effective solutions to practical challenges currently being explored in the application of liquid biopsy technology for early cancer screening in high-risk populations. The project will significantly advance cancer prevention and control efforts in China, serving as an initiative that benefits both the nation and its citizens.