A Single Blood Test for Pan-Cancer Early Screening and Precancerous Monitoring: Aimu Bikang Achieves Breakthrough Technology

Currently, cancer screening products available in China can only detect specific or a subset of tumors. Even “pan-cancer screening” products are limited to detecting only certain types of cancer, which is clearly insufficient compared to the 122 human tumor types listed by the International Agency for Research on Cancer (IARC) of the World Health Organization. The once-popular “Japanese combination cancer screening” is merely a repackaging of existingFragmentation, Localizationeven through mechanical combination of methods, it is still difficult to achieve truly comprehensive cancer screening.Fragmentation and localization have become major pain points in the current cancer screening industry for health checkups.

Mid- and late-stage diagnosis is another pain point in cancer screening.According to statistics, there are approximately 750 cancer screening products on the Chinese market, most of which are lagging or companion diagnostic methods,The average detection sensitivity for Stage T1 is only 20%–30%., most cancers are diagnosed at intermediate or advanced stages, resulting in an early diagnosis rate of only 20% in China.

To address the aforementioned market pain points and gaps, Beijing Aimubikang Technology Co., Ltd. has exclusively introduced German"EDIM Testing System", and leveraging independent research and development, innovatively developedDetection of Pathological Lesions in Tumor Tissues for Apo10 and TKTL1(abbreviated as “Apo10 and TKTL1 Testing”) is a product that enables comprehensive cancer screening with a single test. It boasts exceptionally high sensitivity for early detection, with an average sensitivity of ≥90% for Stage T1 tumors across various types. This performance far surpasses the combined early-detection sensitivity advantages of all currently available cancer screening products. Furthermore, the product can quantitatively assess the extent of tissue lesions during both the precancerous stage and the carcinoma in situ stage, thereby enabling proactive monitoring and early warning for systemic tumors. This allows users to detect cancer risks before the disease develops, putting an end to the era of sudden, unexpected cancer diagnoses and ushering China into a new age of “primary prevention,” characterized by proactive tumor monitoring and precise prevention.

After 21 years of R&D and validation through 200,000 clinical cases, the detection of pathological lesions in tumor tissues using Apo10 and TKTL1 features two disruptive innovations: 1. The first identification of universal tumor markers—Apo10 and TKTL1; 2. The pioneering development of a macrophage-based assay system—the EDIM (Epitope Detection in Monocytes) test system.

In the 1990s, scientists at the German Cancer Research Center (DKFZ) discovered, while undertaking the sequencing of the X chromosome as part of the Human Genome Project,Apo10、TKTL1These two"Systemic Pan-Tumor Biomarkers", research findings published in 1997 revealed that the expression of these two biomarkers is positively correlated with systemic tumor tissue lesions.

Among these, Apo10 is an antigenic epitope of DNaseX. DNaseX plays a key role in the process of apoptosis; its activity is inhibited in tumor cells, yet it is highly expressed and accumulates within them, serving as a biomarker for tumor cells or cells with impaired apoptosis. The accumulation of Apo10 in cells indicates impaired apoptosis, which is the initial stage of tumorigenesis. Elevated Apo10 levels predict the development of tumors or proliferative diseases. Therefore,Apo10 can serve as a reliable biomarker for differentiating proliferative diseases.

TKTL1 is closely associated with cellular glycolytic metabolism. TKTL1 enables tumor cells to rapidly metabolize glucose via glycolysis, generating energy and releasing large amounts of lactate. High expression of TKTL1 creates an acidic microenvironment for tumors, counteracting immune-mediated cytotoxicity and enhancing tumor invasiveness. TKTL1 promotes ribonucleotide synthesis and accelerates DNA replication, thereby increasing the therapeutic resistance of tumor cells. Therefore,High expression of TKTL1 significantly increases the malignancy of lesion tissues, suggesting a poor prognosis.

Elevated levels of both Apo10 and TKTL1 indicate a concurrent increase in tumor proliferative and invasive capacity, representing a prerequisite for tumor progression. The clinical significance of Apo10 and TKTL1 testing aligns with that of histopathological examination, as both reflect the severity of pathological changes in tumor tissue.Detection of Apo10 and TKTL1 enables quantitative assessment of the extent of histopathological lesions in systemic tumors.Therefore, this test can serve as an adjunct to pathological diagnosis of tumors, representing a true form of liquid biopsy in pathology.

EDIM is the abbreviation for Epitope Detection in Monocytes/Macrophages. The “EDIM assay system” is a diagnostic platform that evaluates the severity of tissue pathology by detecting specific pathological tissue antigens phagocytosed by macrophages of the immune system.

Macrophages are antigen-presenting cells with three major characteristics: first, macrophages can actively migrate to all diseased tissues throughout the body, thereforeA single test can detect tumors throughout the entire body.; second, macrophages can actively phagocytose and enrich samples at all stages of tumor formation and development (precancerous lesions, carcinoma in situ, and early-stage cancer), thereby thoroughlyOvercame the challenge of enriching samples from early and ultra-early tumor lesions; third, macrophagesIt demonstrates exceptionally high sensitivity across all stages of tumor formation and development.

“Detection of Apo10 and TKTL1 Lesions in Tumor Tissues” is the first-generation testing product developed under the “EDIM Testing System.” Aimubikang plans to comprehensively develop a new product pipeline under the “EDIM Testing System,” with Phase II focusing on the development of products for tracing the tissue origin of tumors based on specific tumor markers.

“The EDIM detection assay system” features a high degree of innovation and presents significant development challenges,While introducing German technology, AimubikangSigned a ten-year scientific research cooperation agreement with the State Key Laboratory of Molecular Oncology at the Chinese Academy of Medical Sciences,The project appointed Professor Ma Jie, Chief Expert of the National Key R&D Program and the National Science and Technology Major Project, as its Chief Expert in China. Under Professor Ma’s leadership, the research team tackled key antibody-based technologies related to macrophage isolation, permeabilization, and staining of fragmented proteins degraded after macrophage phagocytosis, thereby developing core technologies for detecting the tumor-shared markers Apo10 and TKTL1 associated with macrophage phagocytosis.

Since this assay requires a flow cytometry platform, and the analysis and interpretation of flow cytometry data involve substantial manual workload and are highly susceptible to subjective bias, it is not scalable. To address this, Aimubikang introduced relevant German databases and integrated them with big data on tumor tissue lesions in the Chinese population, thereby generatingApplicable toTissue Lesion Database of the Chinese Population, developed on the basis of big dataAI Interpretation System, AI-based interpretation of test data has laid the foundation for standardized, regulated, and large-scale promotion and application. Currently, the project has completed all technical development and scientific clinical validation, with clinical trial data far exceeding expectations.

In clinical applications, unlike current diagnostic cancer screening methods, Apo10 and TKTL1 testing products are positioned for preventive cancer screening. They focus on preventive "pan-cancer early screening" before cancer develops or during its early stages, as well as preventive "whole-body tumor precancerous monitoring and early warning." These tests primarily target the untapped markets for pan-cancer screening and whole-body tumor preventive monitoring. This testing approach offers exceptional cost-effectiveness and broad significance for preventive screening. It not only demonstrates extremely high sensitivity in early detection but also enables advanced assessment of lesion severity during the precancerous stage, making it highly suitable for pan-cancer screening and tumor monitoring in healthy populations.

For high-risk individuals identified through Apo10 and TKTL1 testing, it is essential to conduct in-depth imaging examinations and source tracing to pinpoint the specific location of the tumor. For suspected primary tumors, this test can be used for “monitoring and follow-up” and “auxiliary early pathological diagnosis,” providing a basis for decision-making regarding tumor biopsy sampling or surgical intervention.The combination of Apo10 and TKTL1 testing with imaging examinations enables a proactive, bidirectional assessment of lesion severity and tumor location, making it an ideal clinical combination.This provides a scientifically sound and highly cost-effective solution for proactive cancer prevention and early auxiliary diagnosis, enabling ChinaFrom the Era of “Passive Cancer Prevention” to “Active Cancer Prevention”, and increase the early diagnosis rate of cancer in China from 20% to over 80%.

The Apo10 and TKTL1 detection technologies have obtained CE certification in the European Union. In clinical studies across 23 types of cancer in the EU, these assays demonstrated a sensitivity of 97.5% and a specificity of 99.5%.With over 200,000 clinical applications in Europe, covering more than 40 major categories of tumors, and having been included in the product catalogs of multiple German insurance companies, its market application is becoming increasingly mature. In double-blind scientific clinical studies involving over 3,000 cases across eight cancer types (non-small cell lung cancer, esophageal cancer, gastric cancer, colorectal cancer, liver cancer, breast cancer, cervical cancer, and nasopharyngeal cancer) conducted at Beijing Hospital and the Sun Yat-sen University Cancer Center, clinical data show thatFor various types of tumors, the average sensitivity at stage T1 is ≥90%, and the average specificity is ≥90%.

Currently, Aimubikang has completed the construction of its GMP-compliant manufacturing facility and is applying for Class III medical device registration with the China Food and Drug Administration (CFDA). Meanwhile, it is making comprehensive preparations for commercial promotion, with a particular focus on launching the world’s first prospective clinical study involving 10,000 participants for “pan-cancer early screening,” thereby establishing expert consensus and public awareness on “pan-cancer early screening.”

The Apo10 and TKTL1 detection products boast unique advantages, including disruptive technology, a high growth ceiling, and strong customer stickiness. As the most cost-effective, widely applicable, and highly sensitive solution for early-stage detection, they represent the premier offering for “pan-cancer early screening and pre-cancerous monitoring.” These products are poised to become essential tools for cancer prevention among the healthy population in China, positioning the company to emerge as a unicorn enterprise in the field of pan-cancer early screening and cancer prevention. The company is currently undergoing Series A financing and seeks to partner with visionary investment institutions strategically positioned in the preventive healthcare sector, working together to participate in and witness the realization of the “Healthy China 2030” initiative!

Appendix: References

1.Biomarkers Apo10 and TKTL1: Epitope-detection in monocytes (EDIM) as a ew diagnostic approach for cholangiocellular, pancreatic and colorectal carcinoma, S. Saman Cancer Biomarkers 27 (2020) 129–137

2.APC/CCDH1 synchronizes ribose-5-phosphate levels and DNA synthesis to cell cycle progression, Yang Li et al. Nat Commun. 2017, 10, 2502 

3.EDIM-TKTL1/Apo10 Blood Test: An InnAP-Te Immune System Based Liquid Biopsy for the Early Detection, Characterization and Targeted Treatment of Cancer Johannes F. Coy Int. J. Mol. Sci. 2017, 18, 878

4.Analysis of circulating CD14D/CD16Dmonocyte-derived macrophages (MDMs) in the peripheral blood of patients with oral squamous cell carcinoma Martin Grimm et al. ORAL AND MAXILLOFACIAL PATH. 2016,03

5.A biomarker based detection and characterization of carcinomas exploiting two fundamental biophysical mechanisms in mammalian cells Martin Grimm et al. BMC Cancer 2013, 13:569

6.Diagnostic use of epitope detection in monocytes blood test for early detection of colon cancer metastasis Natalie Jansen, Johannes F. Coy Future Oncol. (2013) 9(4), 605–609

7.EDIM-TKTL1 blood test: a noninvasive method to detect upregulated glucose metabolism in patients with malignancies Oliver Feyen et al. Future Oncol. (2012) 8(10), 1349–1359

8.Lack of transketolase-like (TKTL) 1 aggravates murine experimental colitis Susanne Bentz et al. Am J Physiol Gastrointest Liver Physiol 300: G598–G607, 2011

9.Transketolase-like protein 1 (TKTL1) is required for rapid cell growth and full viability of human tumor cells Xiaojun Xu et al. Int. J. Cancer: 124, 1330–1337, 2009

10.Expression of transketolase TKTL1 predicts colon and urothelial cancer patient survival: Warburg effect reinterpreted S. Langbein et al. British Journal of Cancer 94, 578 – 585, 2006

11.High-intensity sequencing reveals the sources of plasma circulating cell-free DNA variants，Nat Med. 2019 December ; 25(12): 1928–1937. doi:10.1038/s41591-019-0652-7.

12. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set，DOI:https://doi.org/10.1016/j.annonc.2021.05.806

13.Multicancer detection of early-stage cancers with simultaneous tissue localization using a plasma cfDNA-based targeted methylation assay，DOI: 10.1158/1557-3265.LiqBiop20-IA02 Published June 2020