WUXI, CHINA and PHILADELPHIA, PA / ACCESSWIRE / December 15, 2021 / Lisen Imprinting Diagnostics ("LisenID" or "the company") announces an innovative and ground-breaking epigenetics-based diagnostic solution for early lung cancer detection. The clinical research was published in the Clinical Epigenetics journal (Impact Factor: 6.551) on December 14. The new diagnostic method was based on the QCIGISH (Quantitative Chromogenic Imprinted Gene In-Situ Hybridization) technology developed by LisenID, which can intuitively translate the biallelic and multiallelic expression status of cancer-related imprinted genes into visualized signals in the nuclei thereby allowing the objective clinical quantification of cancer cell expressions. Through QCIGISH, malignant samples can be effectively distinguished from benign lesions based off their epigenetic status. The company's previous methodology paper, which was also published in the Clinical Epigenetics journal in 2020, demonstrated how this technology can be clinically useful for the early and accurate diagnosis of 10 cancer types including lung, thyroid, breast, bladder, prostate, colorectal, esophageal, gastric, pancreatic and skin cancers. The present study particularly focused on lung cancer, which has the highest reported mortality among all cancers. With 431 cases overall in the study, QCIGISH achieved 99% sensitivity and 92% specificity in preoperative cytological diagnosis. High sensitivity was especially demonstrated for early-stage lung cancers (including carcinoma in situ, stage Ia and Ib) and small pulmonary nodules (with diameters less than 2 cm), which was significantly higher than preoperative cytopathology. This method could greatly improve the diagnostic performance of preoperative cytopathology, promote the early diagnosis and treatment of lung cancer, and increase the survival of lung cancer patients.
Professor Chunxue Bai, the co-corresponding author of the paper, Chairman of the Chinese Alliance against Lung Cancer and Director of the Institute of Respiratory Diseases, Zhongshan Hospital, Fudan University, pointed out: "Epigenetic alterations are the earliest molecular changes occurring in cancer, so they are very important and crucial for early cancer diagnosis. Conceptually distinct from indirect cancer detection methods such as methylation sequencing, QCIGISH directly displays the expression status of imprinted genes in the nuclei, providing clearer biomarkers and driving better malignancy discrimination, and has shown very high clinical value in this study."
Professor Bai collaborated with researchers from the Second Affiliated Hospital of Dalian Medical University, Nanjing Zhongda Hospital, Shanghai Changzheng Hospital, Yantai Yuhuangding Hospital, Shanghai Chest Hospital, Shanghai Huashan Hospital, Nanjing First Hospital, Ohio State University, and Johns Hopkins University to screen a panel of imprinted gene biomarkers with significant differential expressions between benign and malignant lung tissues through QCIGISH technology, based on which a quantitative diagnostic model was established. During preoperative detection, the diagnostic model can accurately distinguish benign lung diseases from lung cancer demonstrating far superior diagnostic sensitivity than cytopathology, particularly for early lung cancer and small lung nodules.
Dr. Encheng Li, deputy director of the First Department of Respiratory and Critical Care Medicine at the Second Affiliated Hospital of Dalian Medical University, and Dr. Ming Ding, deputy director of the Department of Respiratory Medicine, Zhongda Hospital Affiliated to Southeast University, highly commended the QCIGISH technology: "Even with the breakthroughs made among multidisciplinary medical technologies these days, the diagnosis of pulmonary nodules continues to remain a major clinical pain point. The QCIGISH technology has shown very high diagnostic accuracy in early lung cancer and small pulmonary nodules, and its value is at least reflected on the following two aspects: first, this technology greatly increased the accuracy of preoperative molecular diagnosis for lung cancer, which could overcome the shortcomings of traditional morphological diagnosis; second, the clinical sample collection process for lung cancer testing could be further simplified as biological specimens near cancer regions can sufficiently provide molecular evidence for cancer diagnosis without the need for very precise clinical sampling. This new technology will not only empower patients to receive accurate early diagnosis and timely treatment, but also will have a significant impact on the overall healthcare management for patients with pulmonary nodules."
Dr. Ning Zhou, founder and CEO of LisenID, added: "The current and upcoming clinical research results of QCIGISH for lung and thyroid cancers, respectively, have given us full confidence in the clinical value of our technology. We will officially launch our lung cancer diagnostic products and clinical testing services in the third to fourth quarters of 2022, which will hopefully benefit patients with lung nodules as early as possible. At the same time, we are pursuing a larger-scale multi-center prospective clinical trial involving more medical centers and higher patient case numbers. We welcome the participation of more medical institutions to help us further improve the accuracy of our lung cancer diagnostic model toward more diverse patient clinical characteristics and lung disease subtypes. Our other cancer detection products for bladder and breast cancers, among others, are also concurrently under development. We hope that through our QCIGISH technology, we are advocating hope to cancer patients everywhere."
About Lisen Imprinting Diagnostics, Inc.
LisenID is mainly dedicated to the research and clinical application of tumor epigenetics to promote early diagnosis and early treatment of cancer. The company is registered in Delaware with R&D centers located in Philadelphia, USA and Wuxi, China. Since its establishment in 2016, the company has developed imprinted gene cancer biomarkers covering more than twelve cancer types including thyroid, lung, bladder, prostate and breast cancers, among others, through the QCIGISH technology, and applied more than 20 international early cancer detection patents. QCIGISH has been clinically validated in more than 7000 medical cases. As an important adjunctive technology to cytology biopsy, imprinted gene tumor detection can greatly improve preoperative diagnostic accuracy driving better clinical treatment decisions and health outcomes.
About Imprinted Genes
Imprinted genes encode regulatory proteins that play key roles in fetal growth and development. In normal tissues, the different epigenetic modification status of paternal and maternal alleles lead to the expression of one gene and the silencing of the other. However, when cancer occurs, the epigenetic modifications of imprinted genes change, causing the originally silent allele to be activated, resulting in uncontrolled cell growth and division, and finally the formation of tumors. Since the expression changes of imprinted genes from mono-allelic to biallelic occur in the earliest cancer stages, the expression status of imprinted genes can be effectively used as sensitive biomarkers for the early detection of cancer.
For further information, please contact:
Ning Zhou | 001-801-6990666| [email protected]
LisenID, CEO
Lisen Imprinting Diagnostics Inc.
#5602, 66 Jinghui East Road
Wuxi, Jiangsu 214135, China
SOURCE: Lisen Imprinting Diagnostics Inc