Lucence Announces Ultra-Sensitive Liquid Biopsy Platform Combining ctDNA Sequencing and Cellular Imaging for Multi-Cancer Early Detection

According to the latest 2020 global cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 19.29 million new cancer cases worldwide in 2020, including 10.06 million in males and 9.23 million in females; there were 9.96 million cancer deaths globally in 2020, including 5.53 million in males and 4.43 million in females.

Chen Minhan, a medical oncologist who previously conducted academic visits at the Cleveland Clinic in the United States, has a more profound personal understanding of these data. The lack of precise and effective methods for cancer screening, diagnosis, and treatment has resulted in many cancer patients being incurable and having short survival periods. Witnessing numerous cancer patients endure painful treatment processes and exorbitant costs, yet still achieve suboptimal therapeutic outcomes, has often left Chen Minhan with a sense of powerlessness, driving him to actively seek out better technologies for cancer diagnosis and treatment.

Subsequently, during his tenure at the Agency for Science, Technology and Research (A*STAR) in Singapore,Chen Minhan led the way in achieving breakthrough discoveries in circulating tumor DNA (ctDNA) and circulating tumor cells, and developed an ultra-sensitive ctDNA liquid biopsy technology.To bring this technology from the laboratory to patients worldwide who need it most, Chen Minhan founded Lucence in Singapore in 2016. The company aims to leverage ultra-sensitive liquid biopsy technology for precise cancer detection, enabling early tumor screening for patients with early-stage cancer and guiding precision treatment for those with advanced-stage disease, thereby improving patient survival rates and quality of life.

Following its establishment, Lucence rapidly developedFlagship liquid biopsy product based on the core technology LucenceHALLMARK,This is"The world's first liquid biopsy product capable of simultaneously detecting cancer viruses and cancer-related gene mutations,"It features ultra-high sensitivity. Studies have demonstrated that LucenceHALLMARK achieves a concordance rate of up to 91% with tissue biopsies. Leveraging its flagship liquid biopsy product, Lucence has rapidly established collaborations with numerous hospitals, enterprises, and university laboratories in the United States and Southeast Asia, bringing precise cancer diagnosis and treatment technologies to local patients.

Shifting focus from the global landscape to China, it becomes evident that the country faces a more severe challenge in cancer prevention and control. In 2020, China recorded 4.57 million new cancer cases and 3 million cancer-related deaths, ranking first globally in both incidence and mortality. To bring its ultra-sensitive liquid biopsy technology to a broader market, Lucence entered the Chinese market in 2019, establishing its presence in Suzhou. Also in 2019, Lucence completed a $20 million Series A financing round led by IHH Healthcare, one of the world’s largest private healthcare providers.

In 2011, cancer researchers Robert A. Weinberg and Douglas Hanahan published “Hallmarks of Cancer: The Next Generation” in the prestigious biological journal Cell, providing important organizing principles for analyzing complex neoplastic diseases. Liquid biopsy is a diagnostic technique that utilizes deep sequencing to detect and identify biomarkers in bodily fluids such as blood. Compared with traditional diagnostic methods like tissue biopsy, liquid biopsy offers advantages including being non-invasive, ease of sample acquisition, the ability for real-time repeated testing, and overcoming tumor heterogeneity.

Since being named one of the Top 10 Breakthrough Technologies of 2015 by the prestigious journal MIT Technology Review, liquid biopsy technology has garnered increasing attention from the corporate capital market for its broad application prospects in early cancer screening and diagnosis, as well as in companion diagnostics. Its popularity has continued to rise, making it a breakthrough point in precision cancer diagnosis and treatment.

Liquid biopsy technology holds immense potential in cancer early screening, early diagnosis, treatment, and prognosis, offering promising solutions to diagnostic and therapeutic challenges across the entire cancer care continuum.

In the context of early cancer screening and diagnosis, liquid biopsy technology enables the early detection of cancer before specific symptoms manifest, providing a critical tool for early discovery and treatment.

In the context of cancer companion diagnostics, liquid biopsy technology can monitor cancer progression and clinical efficacy, providing physicians with personalized medication regimens and therapeutic guidance while avoiding the harm associated with invasive biopsies. Among these applications, companion diagnostics for lung cancer represent the most maturely developed liquid biopsy products.

Currently, multiple cancer liquid biopsy products have entered the market; however, due to insufficient sensitivity, they fail to meet the clinical demands of precision medicine.Studies have shown that the sensitivity of traditional ctDNA liquid biopsy products is generally between 0.5% and 1%. However, in reality, approximately half of the mutations in plasma have an abundance of less than 0.5%, and the ctDNA abundance is even lower in early- to mid-stage cancers. Consequently, using traditional ctDNA liquid biopsy products may result in the missed detection of approximately 50% of low-abundance mutations.

Enhancing detection sensitivity is key to optimizing liquid biopsy technology. Lu Sheng has successfully developed a solution powered by deep learning algorithmsUltra-Sensitive ctDNA Liquid Biopsy TechnologyLucence HALLMARK, limit of detection <0.1%, accuracy >99.9%,It holds significant application value in early cancer detection and companion diagnostics.

Liquid biopsy technology holds immense potential in two major application scenarios: early cancer screening and companion diagnostics. Lu Sheng is strategically positioning its products around these two key areas.

Early cancer screening is a core business of Lucence, and the company is developing multi-omics pan-cancer early screening products. Lucence leveragesLucenceHALLMARK, an ultra-sensitive liquid biopsy technology, performs comprehensive and ultra-sensitive detection of genetic, epigenetic, and virological features of cancer in ctDNA.

Meanwhile,Lu Sheng discovered the milestone circulating tumor-derived endothelial cell clusters and their correlation with early-stage cancer.In March this year, Lucence announced a collaboration with Waseda University to jointly develop an integrated liquid biopsy platform for early screening.LucenceCELL, leveraging this platform to capture high-resolution imaging of thousands of circulating tumor cells and cell clusters in blood samples, thereby establishing an unparalleled atlas of human circulation for each sample to distinguish between cancerous and non-cancerous conditions.

In addition, Dr. Xie Chao, the head of Lucence’s bioinformatics team and champion of the Global Bioinformatics Algorithm Challenge organized by the U.S. Department of Defense, has developedLucenceAI, based on the deep learning Transformer architecture and a binomial noise model at specific locations, to distinguish real signals from noise,Achieved a limit of detection of 0.1% for circulating DNA sequences, reducing manual noise assessment by 99%.

Leveraging LucenceHALLMARK, LucenceCELL, and LucenceAI, Lucence has achieved early detection of multiple cancers while ensuring the superior sensitivity and specificity of its pan-cancer early screening products, thereby saving the lives of numerous patients worldwide through early detection and intervention.

In addition, Lucence is also developingHome-Based Early Cancer Screening Products, using the SAFER sample collector to collect oral and deep-throat saliva, and by analyzing cancer-associated viruses, it can more sensitively and accurately distinguish between cancer-related viral infections and healthy individuals, for early screening of virus-induced cancers. Meanwhile, the SAFER sample collector has also been validated for COVID-19 testing; in the world’s second-largest comparative study of nasopharyngeal swabs versus saliva samples for COVID-19 detection, the SAFER sample collector demonstrated a 36% higher viral detection rate than nasopharyngeal swabs.

In the field of tumor companion diagnostics, Lucence has developed pan-cancer and multiple single-cancer blood tests for treatment selection and dynamic monitoring in patients with advanced-stage disease.Designed for common cancers in China, such as lung and breast cancer, it can detect more mutations than traditional liquid biopsy technologies, thereby avoiding missed detections.

Moving forward, Lucence will intensify its promotional efforts in the Chinese market by actively collaborating with hospitals, enterprises, and university laboratories in China to conduct large-scale prospective cohort studies on early cancer screening. These initiatives aim to demonstrate the clinical value of ultra-sensitive liquid biopsy technology in high-incidence cancers in China, such as colorectal and lung cancer, thereby benefiting a broad population of cancer patients.