Lucence Breaks Through ctDNA+ctRNA Liquid Biopsy with Global Commercial Expansion and Dual-Product Leadership in Cancer Diagnostics

Early in 2024, Lucence, a Singaporean leader in precision medicine, achieved new breakthrough progress.

In January, Lucence launched the upgraded cancer early screening product, Lucence Insight.^TM, a single blood draw can detect 50 types of cancer; this advancement will strongly support earlier cancer detection in patients, particularly those of Asian descent;

In February, LuSheng’s core cancer diagnostic product, LiquidHALLMARK^®Liquid biopsy has further been covered by U.S. Medicare, applicable to patients with advanced solid tumors at all stages, marking a significant milestone for Lucence in advancing personalized oncology care.

Lu Sheng stands at the forefront of liquid biopsy for cancer. After years of technological accumulation, the field has entered a period of rapid harvest, with significant milestone achievements continuously made since 2023, a momentum that has continued into 2024:

Currently, Lucence has progressively built its core competitiveness, overcome numerous obstacles, and achieved continuous breakthroughs in its global commercial product layout.As a Singaporean startup, how has Lucence refined its products to pursue international expansion? And how has it achieved localized implementation in China? VCBeat recently interviewed Dr. Chen Minhan, Founder, CEO, and Medical Director of Lucence.

In 2016, Lucence was spun off from the Agency for Science, Technology and Research (A*STAR) in Singapore.The cornerstone and core of its founding is the scientific research that Dr. Chen Minhan has consistently pursued at New Scientific Research—the ultra-sensitive amplicon enrichment technology, AmpliMark.^TM。

AmpliMark^TMIt is an amplicon-based next-generation sequencing technology independently developed by Lusheng. By employing unique primer designs to amplify selected target regions, it significantly reduces background noise. After the target regions are amplified into millions of copies, the copies are automatically authenticated to eliminate errors.

Initially, Lu Sheng focused on research into ctDNA-based detection of multiple cancer gene mutations and viruses. Over the course of seven years, as his research deepened progressively, he achieved significant accomplishments in the field of tumor genetic testing.

Currently, Lu Sheng has accumulated substantial expertise in ctDNA, and they have also discovered that AmpliMark^TMIt is also capable of detecting and analyzing low-concentration, highly fragmented circulating tumor RNA (ctRNA). ctRNA consists of RNA fragments released into the circulation following tumor cell apoptosis and necrosis, reflecting tumor-derived genetic information and providing a robust basis for early tumor diagnosis, targeted therapy, and prognostic analysis. Therefore, Lu Sheng upgraded the technology platform based on his scientific achievements, enabling combined detection of ctDNA and ctRNA. This technological advancement facilitates the identification of a broader range of tumor-associated gene fusions, helping patients receive personalized treatment at an earlier stage.

Chen Minhan on AmpliMark^TMconfident in the technological application prospects, “With continuous iterative evolution, AmpliMark^TM“It not only addresses the issue of uneven efficiency in common amplification techniques, but also enhances detection accuracy,” he said.Leveraging this core technology, Lucence has not only applied it to guide cancer medication and enable dynamic monitoring but is also dedicated to developing early tumor screening tests, thereby achieving a dual strategic layout in both late-stage cancer diagnosis and early tumor screening.

Currently, in the field of advanced cancer diagnosis, Lu Sheng focuses on medication guidance and dynamic monitoring for cancer patients.They launched LiquidHALLMARK in 2022.^®The ctDNA+ctRNA version formally extends tumor biomarkers into the ctRNA domain, with an upgraded combined detection version launched in 2023.Lucence has become the world’s first liquid biopsy company to offer combined clinical-grade ctDNA and ctRNA testing.

According to the report,LiquidHALLMARK^®It enables combined detection of 27 ctRNA markers guiding clinical medication and novel fusions, as well as mutations in 80 genes, fusions in 10 genes, and somatic mutations at the ctDNA level, covering 15 common cancers including lung cancer, breast cancer, and colorectal cancer.Meanwhile, this product boasts both sensitivity and specificity as high as 99%, with a limit of detection (LOD) as low as 0.1%. The test requires only a single blood draw, and the turnaround time is reduced to just 7 days. This assay significantly meets clinical needs, providing robust support for cancer diagnosis, optimization of treatment selection, and dynamic disease monitoring in patients.

In December 2023, the final results of Lucence’s prospective head-to-head LIQUIK study were presented at the 2023 North American Lung Cancer Conference, demonstrating Lucence LiquidHALLMARK^®The performance of ctDNA+ctRNA is outstanding in the field of liquid biopsy technology. Compared with FDA-approved liquid biopsies, it can detect more lung cancer-related biomarkers recommended by guidelines and maintains high consistency with tissue biopsies (93.2-100%).

The product’s performance continues to be validated, thereby supporting the expansion of Lucence’s commercialization pathway. In March 2023, LiquidHALLMARK^®Covered by U.S. Medicare for lung cancer detection, the product was further included in U.S. Medicare coverage just eleven months later, extending to patients with advanced-stage solid tumors across all stages.

Another key growth driver for Lucence is its multi-cancer early screening product, Lucence Insight™.Lucence Health^TMNext-generation sequencing (NGS)-based technology enables early screening for multiple cancer types, and isThe First Multi-Cancer Early Screening Test Targeting the Asian PopulationA single blood draw can simultaneously detect ten common, high-incidence, high-risk cancers, including lung cancer, breast cancer, and colorectal cancer. In addition to identifying common gene mutations, InSiCano also predicts the organ of origin for the mutated cells, flagging them as key areas for further analysis. At the ESMO Asia 2023 conference held late last year, Lu Sheng presented real-world study results for this product. The data showed that both its positive predictive value and specificity reached 100%, validating the feasibility of using ultra-sensitive technology to detect mutations for early screening.

In January this year, Lucence re-launched the upgraded version of Lucence Insight.^TM, a single blood draw can detect 50 types of cancer.“Given the current lack of routine screening methods for most cancers, this upgrade will strongly support patients, particularly those in Asia, in detecting cancer at an earlier stage, offering them greater hope and more opportunities,” said Chen Minhan.

Since 2023, Lucence has been on a fast track of development. Achieving consecutive breakthroughs over the past two years, it has further solidified its leading position in the field of cancer screening.

Lu Sheng’s ability to achieve rapid development lies in its AmpliMark^TMThe core technological advantages and the team’s relentless efforts have also been strongly supported by the Agency for Science, Technology and Research (A*STAR) and the Joint Industry Research Lab.

The New Science and Enterprise Collaboration Centre is the first overseas branch of the Agency for Science, Technology and Research (A*STAR) Singapore, and the only officially operated science and technology innovation platform from Singapore in China. Located in the Suzhou Industrial Park, the centre has to date facilitated the entry of more than 30 Singaporean start-ups into the Chinese market.

In 2019, Lucence established its presence in the Suzhou Industrial Park through the New Research Enterprise Cooperation Center. The company received not only startup funding, office space, and laboratory support from the center, but also professional guidance in the biopharmaceutical industry, along with access to extensive resources in clinical development, scientific research, upstream and downstream supply chains, and investment and financing. This enabled Lucence to rapidly build a portfolio of high-quality partners and accelerate its commercialization efforts in China.

In Chen Minhan’s view, “Lucence’s rapid development has been inseparable from the consistent support provided by the New Research Enterprise Cooperation Center. They serve as a bridge, fostering connections between Singapore and China. By gaining an in-depth understanding of the strengths and needs of Singaporean enterprises, they carefully identify suitable partners and implementation strategies for us in the Chinese market. This collaboration has not only enabled Lucence to better leverage cross-border resources and expand its business scope, but also strengthened the company’s competitiveness.”

Looking ahead, Lucence will continue its relentless exploration of new liquid biopsy technologies, dedicated to providing earlier and more precise screening methods to meet the needs of cancer patients and healthcare professionals.In addition to product upgrades, Lucence will continue to deepen its product portfolio and accelerate the commercialization of more products. On a global scale, Lucence will further expand product coverage to meet the needs of different regions. The coverage of Laboratory Developed Tests (LDTs) in Southeast Asia will be expanded, ensuring that patients in more regions can access Lucence’s high-quality testing services. Meanwhile, Lucence will strive to obtain medical device approval from Chinese regulatory authorities, further expanding the company’s footprint in the global market.

Now in its eighth year, Lusheng’s entrepreneurial journey is set to continue.