Can Genetron Health's MRD Business Ignite the Next Growth Surge Amid the Tumor Genomic Testing Slowdown?

As tumor genetic testing advances into a more complex and mature phase, targeting the entire cycle of tumor diagnosis and treatment, leveraging foundational general-purpose technologies and channel advantages, deeply expanding product lines, and broadening development pathways have become key points for enterprises to build differentiated competitiveness.

Extending forward from companion diagnostics, cancer early screening has become a sunrise industry worth hundreds of billions; extending backward,The curve for MRD (minimal residual disease) testing is rising rapidly., since the second half of 2020, breakthroughs in MRD detection technology, collaborative R&D efforts, clinical research achievements, and commercialization initiatives have continued to emerge, keeping market enthusiasm at a high level and making it an essential topic at major precision medicine forums.

MRD testing can detect tumor recurrence earlier than traditional imaging, effectively assess prognosis, and help improve patient survival rates. Statistics show that in the solid tumor MRD sector, major players in cancer genetic testing—including Genetron Holdings, Burning Rock Biotech, BGI Genomics, Geneseeq, GenePlus, Tree Diagnostics, ZhiBen Medical, 3DMedcare, and Zenith Genomics—have all entered the market. In contrast, fewer companies are active in the hematologic malignancy MRD sector, such as Genetron Holdings, ZhiBen Medical, and PanGene Medicine; however, their commercialization processes are advancing more rapidly.

On the evening of March 29 (Beijing Time), Genetron Holdings Limited announced its 2021 annual report, with itsIn 2021, the total annual revenue reached RMB 532 million, a year-on-year increase of 25.3%.generate substantial revenue. Furthermore,Gross profit reached RMB 338 million, a year-on-year increase of 30%, with gross margin rising to 63.5%.

As evident from the annual report, Genetron Holdings Limited has seen rapid development in its newly established MRD business, with both hematologic malignancy and solid tumor MRD products advancing swiftly. Collaborations with AstraZeneca and Fosun Pharma are progressing steadily, key data for solid tumor MRD in gastric and colorectal cancers have been released, and hematologic malignancy MRD testing has been deployed nationwide. Its product portfolio, R&D capabilities, and commercial strategies in the MRD sector have set a benchmark for the industry and injected innovation into the oncology NGS field, which had been in a period of stagnation.

For a long time, there has been ongoing debate regarding strategic approaches to minimal residual disease (MRD) detection in hematologic malignancies versus solid tumors, as well as the technical pathways for personalized custom panels versus fixed panels in solid tumor MRD testing. In response to this issue, Genetron Holdings Limited has adopted a “comprehensive coverage” strategy.

Hematologic malignancies are the origin of the MRD field; the concept of MRD was initially proposed in the diagnosis and treatment of leukemia and has become part of the standard clinical practice for hematologic malignancies.

As early as 2018, Adaptive Biotechnologies’ ClonoSEQ received FDA approval. Currently, ClonoSEQ is FDA-approved for use in multiple myeloma, chronic lymphocytic leukemia, and B-cell acute lymphoblastic leukemia.

In China, the MRD track for hematologic malignancies is not crowded.Genetron Holdings Limited is one of the few companies that have strategically focused on MRD testing for hematologic malignancies.

In October 2020, Genetron Holdings Limited partnered with Hangzhou Aimu’en to obtain its blood cancer MRD detection product, Seq-MRD.^®global exclusive licensing agreement. Subsequently, Genetron Holdings Limited applied its proprietary “One-Step” technology to Seq-MRD^®Comprehensively optimize and launch to the market.

Seq-MRD^®Featuring advantages such as high throughput, rapid and convenient operation, stable and accurate results, and cost-effectiveness, it has undergone rigorous performance validation in patient samples with acute lymphoblastic leukemia, multiple myeloma, chronic lymphocytic leukemia, and other conditions. A recent comparative study involving 128 clinically confirmed cases demonstrated that Seq-MRD^®It demonstrates high concordance with conventional flow cytometry (FCM) in the accurate detection of positive cases. More importantly,Ten samples tested negative by FCM, while Seq-MRD^®Capable of accurately detecting positive results,Proof of Seq-MRD^®Exhibits higher sensitivity.

October 2021,Genetron and Fosun Pharma Sign Seq-MRD^®Exclusive Commercialization Cooperation Agreement,Pursuant to the agreement, Genetron Holdings Limited and Jiangsu Fosun Pharmaceutical will jointly sell and co-promote Seq-MRD at key hematology hospitals in designated regions of China, leveraging Fosun Pharmaceutical’s large and experienced marketing team specializing in hematologic oncology.^®, to meet the clinical testing needs of patients with lymphoid hematologic malignancies.

The commercialization of MRD testing for hematologic malignancies began earlier in overseas markets, providing a reference for the market potential of domestic MRD testing for hematologic malignancies. According to Adaptive Biotechnologies’ annual report, more than 22,500 ClonoSEQ tests were performed in 2021, representing a 48% increase from 2020, and pharmaceutical companies paid $10 million in milestone payments for collaborations involving ClonoSEQ.

Based on the attitudes of overseas pharmaceutical companies and medical institutions toward hematologic malignancy MRD products, Genetron Holdings Limited, as one of the few domestic enterprises to have pioneered the commercialization of such products, enjoys optimistic commercial prospects.

In recent years, the application of MRD has begun to expand into the field of solid tumors. China has a large patient population with solid tumors, resulting in greater demand for solid tumor MRD products and substantial market potential. This has also led to the participation of numerous developers in the domestic market for solid tumor MRD products.Genetron Holdings Limited’s distinctive advantage lies in its deep collaboration with AstraZeneca and the use of proprietary, patented liquid biopsy technology.

November 2021,Genetron Holdings Limited Partners with AstraZeneca, leveraging Genetron’s proprietary Mutation Capsule technology and AstraZeneca’s sample capabilities to jointly develop personalized MRD detection products for patients with solid tumors in China.

The performance validation results of Genetron’s personalized custom MRD detection product were published in the Journal of Hematology & Oncology (Impact Factor: 17.4). The data showed that, in peritoneal lavage fluid samples from gastric cancer patients, this productDetects tumor DNA at levels as low as 0.001%, enabling precise prediction of peritoneal metastasis.

Meanwhile, clinical study data on colorectal cancer and liver cancer have also been recently published and accepted. One of the studies, which compared personalized customized MRD monitoring with fixed-panel MRD monitoring after neoadjuvant therapy for locally advanced rectal cancer, was published in eBioMedicine, a subsidiary journal of The Lancet. Data on MRD detection for liver cancer will also be released in 2022.

In the field of minimal residual disease (MRD) detection for solid tumors, industry opinions on technical approaches remain divided. Guardant Health, a proponent of fixed-panel MRD testing, and Natera, an advocate of personalized, custom-made MRD testing, have yet to establish clear superiority over one another.

Tumor-Agnostic (Plasma-Based) Fixed-Panel MRD TestingSelecting high-frequency genes to construct a small panel results in low detection rates for rare tumors.tTumor-informed (based on tumor tissue sequencing) personalized MRD testingWhole-exome sequencing of tumor tissue to generate a personalized genomic variant profile for each patient, which is then incorporated into MRD testing with customized primers enabling parallel detection of multiple mutations in cfDNA samples, represents the most accurate approach for solid tumor MRD detection; however, it is costly, dependent on tumor tissue, and involves a lengthy testing workflow.

To date, the gold standard for MRD detection cited in the most recently published literature (November 2021) is personalized, customized MRD testing, a technical approach adopted by the majority of domestic companies. Genetron Holdings Limited, however, holds the view thatCombining personalized custom testing with fixed panelsFirst, use fixed-panel MRD testing for the majority of patients; for the small subset not covered by the fixed panel, perform personalized custom MRD testing.Balancing Accuracy and Cost, leveraging complementary advantages offers a more accessible solution.

Therefore, in addition to collaborating with AstraZeneca on the development of personalized, customized MRD detection products, Genetron Holdings Limited is also leveraging the unique capability of its Mutation Capsule technology to support the concurrent detection of different variant types, thereby developing fixed-panel MRD detection solutions.Achieving comprehensive coverage of both hematologic and solid tumors, as well as full spectrum coverage of MRD detection technology platforms.

The confidence behind Genetron Holdings’ “all-in” strategy for its MRD business stems not only from its channel capabilities but, more importantly, from the support of its underlying technology.

Extending from companion diagnostics to both upstream and downstream applications, the primary bottleneck lies in technical capability. Whether for early screening or minimal residual disease (MRD) detection, the concentrations of relevant biomarkers in samples are extremely low. For instance, ctDNA-based MRD testing requires achieving a detection limit at the 0.01% level with consistent reliability, posing a significant challenge to a company’s technological prowess.

Genetron Holdings’ Proprietary Innovative TechnologyMutation CapsuleA platform-based innovative technology that is cross-platform, cross-cancer type, and cross-application scenario.. Detects ultra-low levels of tumor mutation information from small blood samples, it can not only be applied in early cancer screening but is also highly suitable for developing products for dynamic monitoring of minimal residual disease in postoperative patients.

In the field of liver cancer, HCCscreen™, an early screening product for hepatocellular carcinoma developed based on Mutation Capsule technology, has received FDA “Breakthrough Device” designation.

As of February 2021, Genetron Holdings Limited had completed follow-up assessments for 1,615 patients who were positive for hepatitis B surface antigen. The data showed that HCCscreen^™Achieved 88% sensitivity and 93% specificity, significantly outperforming the combination of ultrasound and alpha-fetoprotein testing, which yielded 71% sensitivity and 95% specificity. HCCscreen^™It demonstrates excellent performance in detecting early-stage liver cancer, achieving a sensitivity of 85% for tumors smaller than 3 cm and 96% for those measuring 3–5 cm.

Genetron Holdings Limited’s financial report also revealed that its Mutation Capsule technology, used to detect variations and methylation of tumor-related genes in ctDNA, has been granted an invention patent by the China National Intellectual Property Administration.

Moreover, the large-scale popularization of genetic testing and its penetration into primary healthcare settings are becoming increasingly evident. The complex workflow of traditional next-generation sequencing (NGS) hinders the widespread adoption of genetic testing technologies. Another proprietary technology developed by Genetron Holdings Limited"The one-step method" can simplify the steps of genetic testing,Fast speed, low sample input, reduced contamination: Seq-MRD^®The "one-step" method simplifies the workflow, enabling library construction to be completed in a single polymerase chain reaction (PCR) step, thereby significantly reducing the risk of sample contamination and false-positive results.

"One-Step" CanEnabling Healthcare Institutions to Conduct Genetic Testing In-House, effectively promoting the widespread adoption of genetic testing technologies and facilitating the decentralization of medical resources,Empowering More Hospitals with the Capacity to Conduct Independent Testing, empowering tier-2 and tier-3 medical institutions and the primary healthcare market from the top down.

Currently, the 8-gene lung cancer kit, powered by Genetron’s proprietary “One-Step” technology, is applied in the project “Establishment and Clinical Application of Key Technologies for Early Precision Diagnosis of Lung Cancer,” a deep collaboration between Genetron and West China Hospital of Sichuan University. This project was awarded the Second Prize of the National Science and Technology Progress Award in 2020.

Leveraging its Mutation Capsule technology and “One-Step” methodology, Genetron Holdings’ business segments cover the entire cancer care continuum—from early screening and diagnosis to monitoring and drug development services—establishing a competitive moat in comprehensive precision oncology management.

After experiencing the twin booms in companion diagnostics and early cancer screening, the field of oncology genetic testing has temporarily quieted down.

Identifying new opportunities in genetic testing is a critical turning point for enterprises,MRD is likely to be the next catalyst that ignites the industry.It is also a pivotal product that marks a watershed moment in the development of tumor genetic testing.

In the MRD industry, emerging players in tumor genetic testing and top-tier global pharmaceutical companies are flocking to the sector, reflecting the market’s high expectations for MRD and underscoring the industry’s significant value.

Genetron Holdings Limited boasts a robust foundational technology platform and strong commercialization channels, with comprehensive coverage in its MRD product portfolio, particularlyOngoing collaborations with leading pharmaceutical companies have validated the performance and reliability of Genetron Holdings’ MRD detection technology.In an increasingly hot market, Genetron Holdings Limited is poised to take the lead. Moving forward, in addition to advancing R&D and commercialization, the company needs to place greater emphasis on market education and leading the establishment of industry standards.

Shifting our focus to the industry as a whole, “broad deployment and in-depth exploration” remain the central themes of tumor genetic testing. From companion diagnostics and early screening to minimal residual disease (MRD) monitoring, companies in this sector must function as a dynamic, ever-flowing source of innovation. Future success will depend on strategic vision and foundational technological capabilities to continuously uncover new peaks of value.