Genetron Health Unveils MRD Data and Advances Companion Diagnostic Collaboration with AstraZeneca

Genetron Holdings Limited expects its solid tumor Minimal Residual Disease (MRD) technology to achieve a significant milestone this year. Therefore, it recently highlighted new data at the American Association for Cancer Research Annual Meeting and in the journal *Clinical and Translational Medicine*.

In a letter, the company's researchers described their comparison of different residual disease detection methods in a small group of hepatocellular carcinoma patients, which is the company's first MRD target market.

According to the company, recurrence is the main cause of death after liver cancer resection or liver transplantation surgery, and MRD testing can help oncologists better guide postoperative planning for patients.

In this study, researchers analyzed various potential MRD biomarkers: circulating tumor cells (CTCs), and three different methods based on circulating tumor DNA (ctDNA). These methods include a purely tumor-informed fixed assay, a universal fixed assay designed to target frequent mutation regions in HCC and hepatitis B virus, and a fully personalized assay strategy based on tumor exome information, similar to products like Natera's Signatera.

In a sample of 66 patients, the team found that the tumor-informed approach provided the best prediction for HCC recurrence, although the currently universal detection panel also showed strong predictability in the subset of patients with combinatorial mutations. The tumor-agnostic fixed panel performed worse, but its capability improved when combined with CTC detection.

During a conference call with investors this week to discuss the company's first-quarter financial results, Genetron CEO Sizhen Wang said that Genetron continued to plan to offer two MRD assays in the HCC field: one is a tumor-informed approach based on next-generation sequencing, and the other is a fixed panel PCR assay, providing a more affordable solution for self-paying patients.

Evidence from the new study provides an early hint that CTCs could enhance the sensitivity of a tumor-free detection panel, which might be a significant outcome.

The company continues to plan to eventually offer MRD testing in a pan-cancer setting through a collaborative development of an assay with AstraZeneca. The company plans to conduct a pilot by the end of June and aims to expand the supply scope after completing the optimization of the assay by the end of this year.

This pan-cancer product was developed using the same Mutation Capsule technology that forms the core of the tumor-informed HCC approach adopted in the company's new CTM study.

Mutation Capsule enables high-sensitivity detection in low-yield cell-free (cfDNA) samples, with higher conversion efficiency of cfDNA molecules. This, in turn, allows multiple analyses to be performed using a single cfDNA sample, thereby enabling the head-to-head comparisons reported by researchers.

The newly published HCC incorporates retrospective data from colorectal cancer, demonstrating over 91% sensitivity and 95% specificity, while in gastric cancer, a personalized MRD approach can detect tumor DNA in peritoneal lavage samples at an allele frequency of 0.001.

Wang Sizhen said, "Currently, there are only a few companies in China that may have the capability to develop high-performance MRD detection methods. After completing the validation work with AstraZeneca, Genetron's detection method will be exclusively used by this pharmaceutical company for its China-specific trials."

Beyond this first level of cooperation, the two companies may also collaborate to promote the testing method in clinical settings, although these details are still under discussion.

"Both parties are very excited. We will be able to leverage Genetron Holdings Limited’s technology and AstraZeneca’s samples and data, as well as the investment from both sides, to develop this testing method. We see broad prospects in incorporating this approach into clinical trials and serving patients in clinical settings."

One of Genetron Holdings Limited's main competitors, Burning Rock, has already launched its own MRD product.