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Core Advantages
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AnchorIRIS® Library Preparation Technology for DNA Methylation ProfilingTo deal with the low conversion efficiency of bisulfite treatment, we have developed a single-strand DNA library preparation method, AnchorIRIS®, to reach 30-40% of overall conversion rate (10X higher than commercial kits), which achieves ultra-sensitive detection with low initial input (as low as 3 ng) together with a high sequencing depth (5,000X average coverage) (Limit of Detection at 0.01%).
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AnchorMonarch® DNA Methylation Analysis SoftwareRegarding the features of cfDNA methylation sequencing data, AnchorMonarch® DNA Methylation Analysis Software was developed independently to standardize the whole DNA methylation analysis process. The DNA methylation status is analyzed and interpreted through steps, including data quality control, sequence alignment, methylation pattern recognition, and statistical inference. At the same time, the sensitivity and accuracy are improved by deep learning and precise methylation pattern recognitions, together with the highly sensitive experimental technology, to achieve stable and reliable results.
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First-in-Class Product LineThe product pipeline covers more than 70% of high incidence cancers such as lung cancer, breast cancer, digestive system cancer and urinary system cancer. The world's first products with independent intellectual property rights are developed around the two main lines of "one tube of blood" and "one tube of urine", and the whole course management of cancer early screening, early diagnosis, recurrence monitoring and accompanying diagnosis.
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Large Methylation Database for Early-Stage Lung CancerThe lung nodule tissue database differs from the malignant tumor database of TCGA. It has accumulated tens of thousands of samples of Chinese patients and is more consistent with Asian characteristics.
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Advanced NGS Data Analysis CenterIn-depth mining and in-depth integration of the TCGA cancer methylation information database, selected from more than 15,000 cancer cases, 1000-100000 CpG targets, covering 20 cancer species and 35 subtypes, more systematic data analysis, more in-depth mining.
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Cutting-edge Dynamic Big Data and AI Platform for Screening and Early Diagnosis of Lung CancerAnchorDx cooperates with many grade-A tertiary central hospitals in clinical projects, which has developed a cutting-edge dynamic big data and AI platform for the screening and early diagnosis of lung cancer.
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Schedule Advantages of Multi-center Prospective Clinical TrialsThe clinical trial of early screening and early diagnosis of cancer has been carried out in conjunction with a number of large national first-class hospitals, which has the advantage of forward-looking clinical progress
- Patents & Publications
- Patents & Publications
Applications
Granted
Thirty-two patents have been granted, including genomic analysis methods and novel tumor markers exclusively owned by AnchorDx, covering lung, breast, colorectal, bladder, and prostate cancers. Forty-seven patent applications have been accepted domestically and internationally (26 in China, 18 under PCT, and three international patent applications).
Applications
Granted
Twenty-one patents have been granted, including genomic analysis methods and novel tumor markers exclusively owned by AnchorDx, covering lung, breast, colorectal, bladder, and prostate cancers. Forty-seven patent applications have been accepted domestically and internationally (26 in China, 18 under PCT, and three international patent applications).
Publications
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"Accurate diagnosis of pulmonary nodules using a non-invasive DNA methylation test" was published in the internationally renowned academic journal, Journal of Clinical Investigation (Impact Factor (IF): 19.456)
The study jointly completed by 14 research centers, including AnchorDx, The First Affiliated Hospital of Guangzhou Medical University (the team of Prof. Jianxing He/Prof. Wenhua Liang), The Affiliated First Hospital of Sun Yat-Sen University (the team of Prof. Chao Cheng), and The Second Xiangya Hospital of Central South University (the team of Prof. Fenglei Yu), was published on an internationally renowned academic journal, "The Journal of Clinical Investigation" (IF: 19.456).
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"A novel cell-free DNA methylation-based model improves the early detection of colorectal cancer" published on Molecular Oncology (IF: 6.574)
AnchorDx and the team of Prof. Ping Lan and Prof. Xianrui Wu from The Sixth Affiliated Hospital of Sun Yat-sen University published a paper, "A novel cell-free DNA methylation-based model improves the early detection of colorectal cancer", on Molecular Oncology (IF: 7.449)
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"Diagnosis of pulmonary nodules by DNA methylation analysis in bronchoalveolar lavage fluids" published on Clinical Epigenetics (IF: 6.551)
AnchorDx and the team of Prof. Dan Liu and Prof. Weimin Li from West China Hospital published a paper, "Diagnosis of pulmonary nodules by DNA methylation analysis in bronchoalveolar lavage fluids", on Clinical Epigenetics (IF: 7.259)
Scientific Research
- NCT04314245
- NCT04462185
- NCT03651986
- NCT03181490
The BC004 Program is a prospective multicenter clinical study led by Prof. Jiang Huang, the Director of Society of Urology of Chinese Medical Association and the Director of the Department of Urinary Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University and AnchorDx with 11 centers participating. This study aims to recruit 1,200 participants. The purpose of this study is to validate the sensitivity and specificity of urine DNA methylation/mutation test in the diagnosis of bladder uroepithelial carcinoma, and to assess its efficacy and clinical application value in China.
This study was officially initiated in March 2020 and enrollment of subjects was completed in December 2021.
The Angel Program is a prospective observational study led by Academician Nanshan Zhong, AnchorDx and Lung Cancer Initiative (LCI) with six clinical centers participating. The study aims to recruit 3,000 patients with indeterminate pulmonary nodules (IPNs) sized in 5-30 mm. These patients will be followed up for 2-3 years. The clinical information, blood samples, CT imaging DICOM data, and pathological result of each participant will be collected at each visit. The purpose of this study is to validate the clinical, imaging and molecular biomarkers in lung cancers from IPN patients, and further improve the diagnostic efficiency of patients with IPNs.
This study has obtained approval from the Human Genetic Resources Administration of China (HGRAC), and was launched in August 2020.
The "Thunder Project" is a prospective observational study led by Academician Nanshan Zhong and AnchorDx in collaboration with 23 clinical centers. It seeks to enroll 10,560 participants with 5-30 mm pulmonary nodules. All participants will be followed up for 2~3 years. The clinical information, blood sample, CT/LDCT scan DICOM data, diagnostic report and/or pathological diagnosis report, and FFPE tissue sample of each participant will be collected at each visit. The purpose of this study is to comprehensively evaluate the performance and clinical value of the combined model of clinical, AI-assisted CT/LDCT imaging, and NGS-based ctDNA methylation biomarkers for the differential diagnosis and monitoring of benign and malignant pulmonary nodules.
This study was launched in September 2018, and the enrolment of 10,560 subjects were completed in May 2021. Follow-up studies are now being conducted in an orderly manner. The study protocol was published in Translational Lung Cancer Research, an internationally renowned academic journal, in November 2020, attracting widespread attention and recognition from the international medical and academic communities.
This is a prospective-specimen collection, retrospective-blinded-evaluation (ProBE) clinical study co-led by AnchorDx Medical Co. Ltd and the First Affiliated Hospital of Guangzhou Medical University with 14 clinical centers participating. By comparing the results of the pre-surgery ctDNA methylation test with the post-surgery pathological diagnosis of benign and malignant pulmonary nodules, the comprehensive diagnostic performance of the ctDNA methylation test in clinical applications was validated in terms of sensitivity and specificity.
The study was formally launched in June 2017, and enrollment of 1490 subjects were completed by February 2019. The research team have completed the development and validation of the PulmoSeek model, which was the first diagnostic tool for classifying benign and malignant pulmonary nodules based on polygene DNA methylation biomarkers in plasma. The results were published in the internationally renowned medical journal--The Journal of Clinical Investigation.