Genecast Launches Pan-Cancer MRD Assay 'WeeSure™', Expanding Its Solid Tumor MRD Portfolio Ahead of IPO

From NIPT and tumor NGS to mNGS, and further to early cancer screening and MRD, identifying new high-demand application scenarios has consistently been the strategic approach of the genetic testing industry. Currently, MRD has become the absolute focal point in the oncology genetic testing sector.

MRD testing can detect minimal residual disease that is difficult to identify through conventional clinical methods, enabling early detection of tumor recurrence. It represents a market with greater growth potential in the field of tumor genetic testing beyond companion diagnostics. Among various biomarkers, ctDNA is the most promising for MRD testing.

In the field of MRD testing for solid tumors, most companies focus on single cancer types. In contrast, pan-cancer MRD testing is not limited to specific cancer types and benefits a broader patient population. It enables dynamic monitoring and recurrence risk assessment for patients who have undergone curative surgery or curative treatment, making it a highly sought-after MRD testing product for solid tumors in recent years.

The most well-known pan-cancer MRD detection method is Signatera, developed by Natera in the United States. This product has been clinically validated in colon cancer, breast cancer, lung cancer, and bladder cancer, with recurrence prediction sensitivities of 88%, 89%, 92%, and 100%, respectively.

Currently, Signatera has achieved broad commercialization and has been included in the U.S. government’s Medicare program. Regardless of tumor type, Medicare beneficiaries receiving immunotherapy can use Signatera for testing.

Recently, Genecast, a pioneer in MRD testing for solid tumors in China, has made another major move by announcing the launch of its pan-cancer MRD testing product—Weishibo^®。

It is noteworthy that MRD testing for solid tumors has transcended the narrow concept of “monitoring tumor recurrence.” Instead, it now spans the entire cancer diagnosis and treatment continuum, ranging from prognostic assessment and predicting recurrence prior to radiological evidence, to providing guidance for medication selection, evaluating therapeutic efficacy, and monitoring resistant clones. As such, it represents a disruptive and cost-effective tool in oncology care.

From the perspective of pharmaceutical companies, many have shifted their focus from patients with advanced-stage cancer to those in early stages, encompassing both adjuvant and neoadjuvant therapies. This trend toward expanding from advanced to early-stage disease is evident across both targeted therapies and immunotherapies.

Compared with advanced-stage disease, patients with early-stage tumors require longer follow-up periods, larger-scale studies, and greater investment in follow-up management to achieve the prespecified clinical endpoints. AndMRD testing for early-stage tumor patients naturally aligns with pharmaceutical companies' needs in developing drugs for early-stage tumors.

In June 2022, the FDA released a draft industry guidance on the application of ctDNA in drug development for early-stage solid tumors, encouraging the use of ctDNA-based MRD detection to facilitate the development of therapeutic agents for early-stage solid tumors. The draft indicates that ctDNA testing can not only identify patients with targetable mutations for inclusion in clinical trials but also, through ctDNA-based MRD assessment, enrich for patients at high risk of recurrence, evaluate treatment response, and even serve as an early study endpoint. MRD testing is becoming an integral part of drug development, significantly enhancing its efficiency.

“We have also found in a collaboration with a pharmaceutical company that, in the immunotherapy of patients with lung squamous cell carcinoma, ctDNA-based MRD testing can provide better evaluation metrics for immunotherapy than imaging. For testing companies, it is possible to incorporate MRD testing into clinical trials and develop companion diagnostic products, thereby achieving win-win cooperation with pharmaceutical companies,” said Dr. Chen Weizhi, CSO of Genecast.

“In addition, high-sensitivity detection of drug targets based on ctDNA aligns with the emerging needs of targeted drug development. Currently, tumor-targeted drugs are designed against molecular targets driven by specific gene mutations, rather than being limited to a particular cancer type. Instead, they enable precise patient stratification for mutations associated with drug sensitivity across pan-solid tumors. Pan-cancer MRD testing can provide efficient support for the development of such therapies,” added Dr. Chen Weizhi.

For pan-cancer MRD products, guiding treatment decisions is one of their core values. By accurately assessing MRD status and the status of targeted mutations, these products enable patients with a wider variety of cancer types to benefit, thereby addressing a larger market.

Genecast has been researching ctDNA-based MRD technology for many years. In the earlier large-scale technical validation, the company’s MRD detection technology platform, MinerVa^®It not only ensures the accuracy of single-site tumor detection, but also, leveraging patented algorithms, guarantees consistency across different tumor patients.Sample-specific stability was consistently maintained at 99.5%–99.9%, with a limit of detection (LOD) as low as 0.007%.

Previously, the company had launched two MRD detection products for solid tumors, targeting early- to mid-stage non-small cell lung cancerLangweibo™, and for stage I–III colorectal cancerChangweibo™。

Among these, lung cancer is the leading cancer in China, with its incidence and mortality rates ranking at the forefront among all types of tumors, making it one of the most representative malignancies. With advancements in early diagnostic technologies for lung cancer, an increasing number of patients are being diagnosed and treated at early stages, leading to a surge in demand for minimal residual disease (MRD) testing.

Meanwhile, the development of MRD detection products for lung cancer poses the greatest challenge. Numerous studies have shown that the rate of ctDNA release into the bloodstream is relatively low in patients with early-stage lung cancer, particularly in lung adenocarcinoma harboring hotspot driver mutations, which presents a significant challenge to detection sensitivity. Furthermore, the postoperative recurrence rate is low in early-stage lung cancer, especially in Stage I disease. Consequently, MRD studies involving a high proportion of early-stage patients impose stringent requirements on the specificity of technical methods. Genecast’s MRD research has demonstrated excellent performance in early-stage lung cancer cohorts, providing a solid technical foundation for expansion into multi-cancer detection.

Notably, in MRD detection for solid tumors, the most commonly used strategy involves tracking patients’ personalized mutational profiles after curative-intent treatment, based on the unique mutational characteristics of their primary tumors. Fixed, pre-designed small panels composed of high-frequency hotspot mutation genes can track only a limited number of mutations and fail to comprehensively cover all cancer patients across most tumor types. WhereasGenecast’s comprehensive large panel, which covers over 700 genes including those involved in cancer pathways, is supplemented by personalized customization strategies. It features broad applicability and is suitable for all solid tumors.

Therefore, after conducting rigorous preliminary clinical studies and validating technical performance, Genecast has expanded its scope from lung cancer and colorectal cancer to pan-cancer indications, launchingPan-Cancer MRD Detection Product—Weishibo^®, so as to benefit more patients with early-stage tumors.

A high-quality MRD detection product must first possess excellent sensitivity and specificity. Weishibo^®Based on MinerVa^®Platform developed. MinerVa^®The platform is designed around depth, breadth, and cleanliness, utilizing a 769-gene panel (product: Baishibo^®), it can comprehensively cover various mutation types, including driver mutations, clonal mutations, and passenger mutations. By employing a panel design with differential weighting, it doubles the sequencing depth for hotspot regions in lung cancer and colorectal cancer, thereby ensuring detection sensitivity.

In terms of specificity, Genecast’s Big Data Center maintains a large-sample baseline noise library of negative plasma. By modeling multi-dimensional noise features along both locus and fragment axes, and employing multi-variant joint confidence probability analysis, it ensures the specificity of MRD detection.

Currently, Genecast has officially launched Weishibo^®commercial promotion.

Du Bo, founder and CEO of Genecast, candidly acknowledged that the commercial promotion of pan-cancer MRD detection products faces relatively significant challenges. For instance, clinical practitioners have a relatively high level of awareness regarding MRD testing in lung cancer. However, in liver cancer, treatment options are not as diverse as those for lung cancer, and there is considerable room for improving the recognition of the clinical value of MRD testing.

“Physicians require robust interventional clinical evidence before they will endorse a new product. Therefore,The accumulation of more clinical evidence, the conduct of more prospective clinical studies, and the gathering of more data meaningful for clinical decision-making will play a decisive role in the successful promotion of pan-cancer MRD detection products.”

Looking ahead, in the field of minimal residual disease (MRD) detection for solid tumors, Genecast will continue to accumulate robust clinical evidence through more prospective clinical trials in cancer types such as liver cancer and esophageal cancer. The company will strengthen market education, validate the value of its pan-cancer MRD detection technology platform, further explore its clinical significance, and promote the development of China’s pan-cancer MRD detection sector, enabling rapid application across multiple cancer types. Meanwhile, Genecast will actively engage with regulatory authorities to foster standardized and regulated industry development.

“Only by truly focusing on the continuous exploration of MRD detection technologies, products, and their clinical value can one become a professional and reliable partner for physicians in making clinical decisions,” summarized Du Bo.