BEIJING, Feb. 24, 2021 /PRNewswire/ -- Berry Oncology Corporation, the shareholding subsidiary of Berry Genomics, announced the results of a case-control study on the effectiveness of a novel diagnostic method for detecting hepatocellular carcinoma (HCC) in patients with liver cirrhosis, demonstrating the new model had greater accuracy and sensitivity compared to existing screening methods.
The study, published in Cell Research, featured both China and the U.S.-based authors and research teams led separately by Prof. Hong-Yang Wang of the National Center for Liver Cancer, Prof. Jin-Lin Hou of Nanfang Hospital, Southern Medical University and Dr. Lin Wu and Dr. Jian Bai of Berry Oncology. The researchers collected cell-free DNA (cfDNA) samples from a total of 3,234 individuals, including 2,250 patients with liver cirrhosis (LC), 508 with HCC, and 476 healthy controls (CTRL) from 13 hospitals in 11 provinces in China.
Scientists employed a state-of-the-art next-generation sequencing (NGS) technology to acquire genome-wide 5-hydroxymethylcytosine (5-hmc), nucleosome footprint (NF), 5′ end motif and fragmentation profiles of cfDNAs from all enrolled individuals. Researchers then used a logistic regression method to construct a weighted diagnostic model based on the performance of these four features.
The novel diagnostic model, called HIFI, achieved a sensitivity of 95.42%, a specificity of 97.83%, and an AUC of 0.996 in the study, a higher accuracy in differentiating HCC from liver cirrhosis than existing diagnosis tests measuring AFP or PIVKA-II. The method was also able to detect signs of liver cancer with 93.9% accuracy among individuals that had tested negative using an AFP test, and with 90.9% accuracy among those that tested negative using a PIVKA-II test.
These results can be achieved regardless of a patient's age, HBV status, Child-Pugh score, BCLC stage, tumor size, or AFP status. Furthermore, the HIFI model can also be used to screen for other major cancers, such as lung cancer.
HCC, the most common form of liver cancer, is the second most deadly cancer worldwide. Patients with liver cirrhosis are at the highest risk of developing HCC, and diagnosis at an early stage contributes to an improved prognosis with the possibility of curative treatment.
"Due to the low accuracy of current diagnostic methods, new non-invasive strategies for early HCC diagnosis in cirrhotic patients are urgently needed," said authors of the study. "The HIFI method exhibited an excellent performance for early-stage HCC diagnosis compared to other non-invasive methods, and has huge potential of HCC detection for cirrhotic patients."
According to Berry Oncology CEO Jun Zhou, the result of this study is a milestone for Berry Oncology in tumor screening and early detection. As the forerunner in the field of genomic testing of cancers in China, this research aligns with Berry's strategic road map will accelerate Berry's advances in early screening of high-risk and high-incidence tumors and can also contribute to similar goals set out in China's 13th Five-Year Plan.
In addition to Berry Oncology, authors of the study also hail from the National Center for Liver Cancer, Shanghai Eastern Hepatobiliary Surgery Hospital in Shanghai, the Memorial Sloan Kettering Cancer Center in New York, Mengchao Hepatobiliary Hospital of Fujian Medical University in Fuzhou, the Second Hospital of Shandong University in Jinan, Ningbo Hwamei Hospital in Ningbo, Nanfang Hospital in Guangzhou and more.
About Berry Oncology
Berry Oncology, founded in 2017 as a member company of Berry Genomics, focuses on genetic testing of cancers. Driven by the mission of "Diagnose all cancers early, treat all patients precisely", we have established for cancer patients and high-risk population a complete system of genetic testing products and services, including tumor genetic susceptibility analysis, early screening, as well as as companion diagnostics, response monitoring and prognosis prediction of both targeted and immune therapies. For cancer early detection, we have launched a series of clinical research projects for early screening and early diagnosis, covering liver cancer, lung cancer, gynecologic cancer, and etc. Berry Oncology has three centers (manufacture, supercomputing, R&D) located in Fuzhou and Beijing. We serve and cooperate with more than 600 Class 3A hospitals across the country, and have provided valuable genetic testing services for hundreds of thousands of patients.
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About Berry Genomics
Founded in May 2010, Berry Genomics is a leading company in clinical genomics and life science in China. Berry Genomics is dedicated to research, development and commercialization of genetic test technologies in clinical applications. Berry Genomics aims to assist accurate diagnosis of diseases throughout the full human life circle, and to improve human health.
As a company with strong R&D capability, Berry Genomics pioneered the first NGS-based genetic test, NIPT, in China back in 2010. The company currently provides NGS- based tests for many genetic diseases and cancers from preconception to adulthood. Berry Genomics is leading in the clinical study of early clinical detection of liver cancer in the world. Exploring the use of the third-generation sequencing technology in both clinical field and scientific study is ongoing.
Berry Genomics has around 1500 employees dedicating to developing products and providing services for over 4000 organizations and facilities home and abroad, including hospitals, research institutions, universities and corporations.
Berry Genomics has been listed on A-share market in China since 2017 under the stock code: 000710.
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SOURCE Berry Oncology Corporation