Hefei Genomics Launches Liver Cancer Early Screening Product 'Laisining', Kicking Off Widespread Early Detection Initiative

On August 16, at the “Cloud Forum on Early Diagnosis and Screening of Liver Cancer” jointly hosted by the People’s Daily Health Client and Health Times, as well as the launch event for Gene+’s new liver cancer early screening product “Laishining,” Gene+ officially launched its liver cancer early screening product, Laishining (Liver Screening).

This is Genetron Health’s first tumor early screening product based on NGS technology. Since April 2018, Genetron Health, in collaboration with the National Liver Cancer Science Center/Shanghai Eastern Hepatobiliary Surgery Hospital and Nanfang Hospital of Southern Medical University, has jointly launched the PreCar project—a prospective cohort study involving nearly 20 hospitals across China to screen for biomarkers enabling ultra-early warning of liver cancer. Leveraging the breakthrough achievements from this project, Genetron Health has developed LaiSiNing, a clinically applicable early screening product.

Not long ago, Huirui Genomics launched its 654-gene large panel for detection in intermediate and advanced-stage cancers. The launch of Lesining marks the initial realization of Huirui Genomics’ product strategy of “one core, bidirectional expansion,” which closely aligns with clinical needs to facilitate the clinical translation of genetic testing technologies into two directions: early screening and diagnosis of cancer, and detection in intermediate and advanced-stage cancer.

The clinical translation of gene sequencing technology involves four stages: The first stage is building a foundational technology platform, which is the most basic yet core requirement for gene sequencing companies; the second stage is establishing models and conducting retrospective studies, i.e., validating the model’s algorithms using known data, thereby laying the preliminary groundwork for clinical application; the third stage is conducting prospective clinical trials, i.e., testing the model from the previous stage in real-world settings, where a larger number of enrolled patients yields more authentic clinical outcomes; the fourth stage is the industrialization and commercial implementation of the product.

Launched in April 2018 by three institutions, the PreCar project is China’s first ultra-large-scale cohort study to screen, identify, and validate ultra-early warning biomarkers for hepatocellular carcinoma (HCC) in peripheral blood using whole-genome sequencing and multi-class biomarker analysis technologies. According to publicly available information both domestically and internationally, PreCar is the largest and most rapidly advancing clinical research project globally for early screening and diagnosis of HCC among similar initiatives, and it remains the only such project to have published its prospective trial data. In 2019, the study announced that, compared with the traditional gold standard, PreCar can provide HCC warnings 6 to 12 months earlier, thereby securing a valuable window of opportunity for early treatment in HCC patients.

The PreCar project has already entered its third phase, while the market launch of Leisinings signifies that Huirui Gene has officially commenced work on its fourth phase.

Currently, early screening and diagnosis of liver cancer primarily rely on serum biomarkers and imaging techniques. The detection rate for early-stage liver cancer using a single modality is only 47%. The detection rate based solely on serum biomarkers is also suboptimal.

HuiRui Gene’s choice to focus on early screening for liver cancer as a breakthrough point stems from the recognition of substantial clinical demand: liver cancer is the fourth most prevalent cancer in China, with a cumulative mortality rate of 32.6%. Furthermore, there is a well-defined high-risk population for liver cancer, including patients with chronic hepatitis and liver cirrhosis, who exhibit significantly higher incidence rates. Most importantly, the liver is an organ closely associated with the bloodstream; once cancer cells form, they rapidly enter the circulation, making it highly suitable for blood-based detection using HuiRui Gene’s core liquid biopsy technology, cSMART.

As an effective complement to existing clinical screening and diagnostic methods, genetic testing technology has opened up new avenues for addressing the longstanding challenge of early warning and screening for tumors. It holds promise for establishing an “iron triangle” for early hepatocellular carcinoma (HCC) screening, together with serum biomarker testing and imaging examinations. Huirui Gene has seized the opportune moment, leveraging its strengths in clinical demand, market potential, and technological reserves.

For early screening and diagnosis of liver cancer, the greatest technical challenge lies in distinguishing the subtle molecular biological differences between high-risk populations (such as those with liver cirrhosis) and patients with liver cancer. Laisining’s product design adopts a strategy of “casting a wide net to capture abundant data, then selecting the optimal approach”: by systematically evaluating a comprehensive panel of multi-omics biomarkers for early screening, it has built and refined its technical platform and AI analysis framework. The company strictly controls patient enrollment in prospective clinical cohorts and ensures long-term follow-up of enrolled participants. This approach has ultimately achieved Laisining’s high precision: maintaining a specificity of 93.1% while achieving a sensitivity of over 95.7%.

Regarding the "early" aspect of early screening, Laishining also fully takes clinical value into account. Currently, the follow-up interval for individuals at high risk of liver cancer is approximately six months. Therefore, by accurately screening for circulating tumor DNA (ctDNA) in peripheral blood through genetic testing at these follow-up time points, and subsequently verifying the results with contrast-enhanced MRI, it is possible to promptly confirm a diagnosis at the early or very early stages of liver cancer, thereby avoiding missed opportunities within the critical treatment window. Furthermore, by targeting high-risk populations and selecting appropriate timing for early screening, the test avoids generating cancer alerts that lack clinical significance.

In the PreCar study, a 57-year-old male with hepatitis B and liver cirrhosis was enrolled. During an 18-month follow-up period, four visits involving alpha-fetoprotein testing and ultrasound examinations showed no signs of hepatocellular carcinoma (HCC) risk. However, Huihe Genetics’ genetic screening test for liver cancer indicated a high risk of malignant transformation. Subsequently, at the fourth visit, the patient was diagnosed with early-stage hepatocellular carcinoma.

Lesining products not only assist in the early screening and diagnosis of liver cancer but also serve to monitor recurrence, providing patients with precise postoperative dynamic monitoring. This achieves a bidirectional extension of gene testing technology into both early tumor screening/diagnosis and precision diagnosis and treatment throughout the entire course of the disease.

The 2019 Government Work Report delivered at the Two Sessions stated: “We must implement cancer prevention and control initiatives, advance preventive screening, early diagnosis and early treatment, and tackle key scientific and technological challenges, with a focus on alleviating critical issues affecting people’s livelihoods.” In the same year, the State Council Executive Meeting emphasized the need to promote cancer screening and early diagnosis and treatment, strengthen breakthroughs in key technologies, and support clinical research and application of new technologies for tumor diagnosis and therapy. Cancer prevention and screening are crucial to the effective implementation of the “Healthy China 2030” plan, reflect the central government’s earnest expectation to improve the health status of the entire population, and constitute an imperative national-level major health initiative.

From an industry perspective, early screening and diagnosis of tumors hold broad market prospects. Taking liver cancer as an example, according to a research report by Southwest Securities, the market potential for early screening and diagnosis of liver cancer in China reaches as high as RMB 200 billion, excluding considerations of market penetration rate.

Driven by both policy support and market demand, early screening and diagnosis of liver cancer have become a hot topic in domestic and international research. In 2019, Exact Sciences’ blood-based test for early-stage hepatocellular carcinoma (HCC) received Breakthrough Device Designation from the U.S. FDA. Meanwhile, companies such as Grail and Thrive Earlier Detection are actively developing multi-cancer early detection solutions. In China, numerous research institutions have launched studies in this field, and several enterprises, including Huihe Gene, are actively entering the liver cancer early screening and diagnosis sector, advancing product commercialization.

The past decade has been the golden age for the clinical application of NGS. Ten years ago, clinical genetic testing began with non-invasive prenatal testing (NIPT); seven years ago, it expanded into the detection of mid-to-late stage cancers; and now, the era of early cancer screening and diagnosis is about to begin.

Over the past decade, rapid development has seen technological advancements clearly exceed expectations. Market education has been largely completed, while the genetic testing market is still in its early stages of initiation.

Laisining is poised to become a benchmark for early screening products for liver cancer. The competition in early tumor screening and diagnosis has only just begun.