From Late-Stage to Early Detection: Genecast's Comprehensive Oncology Strategy and Product Portfolio

As early as 2010, when Berry Genomics was founded, Zhou Daixing already had the idea of venturing into the oncology field. Since Berry Genomics initially built its business on non-invasive chromosomal disease testing, it was natural for the company to consider expanding into monogenic diseases. Shortly after the team was established, they began researching detection technologies for monogenic diseases, which later evolved into Circulating Single-Molecule Amplification and Resequencing Technology (cSMART).

When the technical team discovered that this technology could detect mutations in cell-free fetal DNA present at extremely low levels in maternal blood, they realized that cSMART technology could be applied to non-invasive tumor detection with considerable feasibility.

In 2013, Berry Genomics formally established its Oncology Division. Subsequently, the Onconi molecular diagnostic products for cancer, with cSMART as one of the core technologies, were launched.

This marked the beginning of Berry Genomics’ oncology business and the origin of Huirui Gene. Building on this product, Berry Genomics developed a series of offerings, including medication guidance for mid-to-late stage cancer patients and treatment efficacy monitoring, thereby laying a solid foundation for Huirui Gene’s current success.

OncoYi’s inaugural diagnostic application is a liquid biopsy for targeted therapy in non-small cell lung cancer (NSCLC), given that the targeted genetic landscape of NSCLC has been thoroughly elucidated and clinicians are highly familiar with the correlation between specific gene mutations and therapeutic agents.

Following the establishment of its Oncology Division, Berry Genomics successively launched testing products for gynecological cancers and colorectal cancer. As the Oncology Division was spun off into an independent entity, Ruiyi Genomics, it formally initiated research on early screening projects, marking an expansion from mid-to-late stage tumor detection to early warning and screening.

OncoBenefit is a series of tumor molecular diagnostic products based on the internationally and domestically patented cSMART technology and deeply optimized PCR amplicon sequencing technology (tPAS assay). It covers all aspects of targeted therapy and immunotherapy research and application for solid tumors, including non-small cell lung cancer, colorectal cancer, comprehensive pan-cancer gene profiling, and hereditary tumor testing.

Berry Genomics’ independently developed cSMART patented technology can capture ultra-low fractions of ctDNA fragments in blood, enabling absolute quantification of gene mutation detection. Meanwhile, by leveraging comprehensive interpretation of its proprietary Chinese population database and advanced international databases, the company provides physicians and patients with accurate and easy-to-understand test reports.

Moreover, technological upgrades have never ceased in Berry Genomics’ laboratories. Through further innovation, the upgraded cSMART 2.0 technology not only retains all the advantages of the original cSMART technology in terms of sample volume requirements and sensitivity, but also achieves a substantial increase in the number of genes detectable in blood tests, along with a significant improvement in the utilization rate of sequencing data.

OncoYi is a comprehensive tumor gene detection product based on high-throughput sequencing, capable of accurately detecting various mutations such as SNV, Indel, and Fusion. Cancer is a type of genetic disease, with at least 140 known driver genes associated with tumorigenesis. A typical cancer cell usually carries 2-8 gene mutations. OncoYi can simultaneously detect multiple genes, loci, and mutation types, using just 10ml of venous blood to screen for hundreds of cancer-related genes.

As exploration and discoveries into the pathogenesis of tumors continue, it has become increasingly clear within the industry that genotyping directly impacts the efficacy of tumor treatment: genetic differences among patients may lead to varying, or even diametrically opposite, therapeutic responses to the same drug. Taking targeted therapy for non-small cell lung cancer (NSCLC) as an example, gefitinib demonstrates favorable efficacy in patients with EGFR sensitizing mutations, but shows poor efficacy in those with resistance-conferring mutations.

Therefore, for the treatment of cancer patients, genetic testing prior to medication is crucial. Based on precise testing at the genetic level, doctors can provide more accurate guidance on medication.

As a member enterprise of Berry Genomics, HelixGene has obtained exclusive authorization for its tumor-related technology patents and product services within mainland China. This not only integrates and aligns its oncology business but also provides HelixGene with a significantly high starting point.

In August 2017, Berry Genomics initiated the establishment of He Rui Gene, which assumed all oncology-related business. By the end of the same year, He Rui Gene secured a one-time financing round of RMB 800 million. Shortly thereafter, the company publicly announced its long-planned research on early cancer screening.

On April 22, 2018, Huirui Genomics announced the joint launch of a nationwide, multicenter, prospective screening project for ultra-early warning of liver cancer with the National Center for Liver Cancer/Shanghai Eastern Hepatobiliary Surgery Hospital and Guangzhou Nanfang Hospital. This is the first and only ongoing large-scale prospective cohort study on early liver cancer screening in China, marking a solid first step for Huirui Genomics’ early screening and diagnosis business segment.

Prior to this, Herui Genomics had already launched its pilot study. Concurrently with the project launch announcement, the company had accumulated substantial data related to early tumor diagnosis, completed the comprehensive construction of its technical platform, and preliminarily established multi-omics experimental protocols as well as classification biomarkers and analytical algorithms for early liver cancer screening, thereby laying the foundation for an ultra-large-scale prospective cohort study.

Herui Gene also revealed that over the next three years, the company will launch more research projects on early cancer diagnosis, gradually expanding coverage from specific cancers to a broader range of tumor types.

As a member enterprise incubated by Berry Genomics, He Rui Genetics has inherited Berry’s mission and vision for cancer prevention and treatment.

At the same time, during the initial stage, the technology, capital, and team provided by Berry Genomics and all shareholders made this company unique—Herui Gene possesses more abundant resources and shoulders the mission of solving the century-old challenge of tumor genetic testing, especially early diagnosis of tumors, not only in China but also globally.

This inevitably brings to mind the relationship between Illumina and Grail. Both companies share a similar trajectory: backed by industry leaders, developing early cancer screening technologies, and spinning off from their parent companies after securing external investment. He Rui Genomics embarked on this path at roughly the same time as Grail, and both are currently conducting large-scale prospective clinical trials, with the shared aspiration of realizing the dream of early cancer diagnosis in the near future.

Both high-caliber companies are destined to attract industry attention and anticipation. However, unlike Grail, Huirui Genomics is not only making substantial investments in early cancer screening but also subjecting its mature mid-to-late stage tumor detection products to market validation, thereby generating valuable market insights and clinical data on advanced-stage cancers. It is believed that in the near future, they will drive the widespread clinical adoption of early cancer diagnosis and screening technologies, realizing the aspirational vision of “early diagnosis and treatment for all cancers, and precision therapy for every patient.”