Release date: 2018-07-09
Recently, blood-based DNA sequencing panels developed by Exact Sciences and the Mayo Clinic have performed well in a phase 2 clinical validation study to accurately detect liver cancer at various stages, and the detection specificity is more than commonly used. Serum test. This new invention is expected to help liver cancer patients diagnose and take treatment as soon as possible.
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, usually occurring in patients with chronic liver disease, such as cirrhosis caused by hepatitis B or hepatitis C virus infection. HCC affects about 500,000 people worldwide, with the highest incidence in Asia and Africa. China is a major country for HCC, and more than half of all HCC cases worldwide are in China. The five-year survival rate of advanced liver cancer is less than 5%. However, if the cancer is screened and treated early, the survival rate can be increased to 40% to 70%.
At present, the detection methods for patients with cirrhosis mainly include ultrasonography and measurement of alpha-fetoprotein (AFP) levels. About half of patients with advanced HCC have high levels of AFP, a protein produced during early fetal development, also produced from the liver and various tumors (including HCC). However, these tests are less sensitive to early disease than advanced disease. In addition, AFP levels can be affected by other factors, such as pregnancy and other tumors can cause positive results, leading to misdiagnosis.
The genetic detection panel brought by Exact Sciences and Mayo Clinic can detect HCC by tracking six methylated DNA markers in plasma. The panel uses permethyl group DNA sequencing to identify HCC markers. To assess the effect of the panel, the investigators used frozen plasma samples from separate files for evaluation, including 95 confirmed HCC case samples, 51 cirrhosis control samples, and 98 control samples without a history of liver disease or cancer.
The results showed that the overall sensitivity of the test panel was 95%. Specifically, stage 0 disease was 75%, stage A was 93%, stage B was 93%, stage C was 96%, and stage D was 100%. This panel is equally excellent at avoiding false positive results. It has a specificity of 95% in the healthy control group and 86% in the cirrhosis control group, which is more accurate than the AFP level test used in the clinic. Exact Sciences and Mayo Clinic hope to further optimize panel design and plasma collection conditions prior to clinical phase 3 studies.
Exact Sciences is headquartered in Madison, Wisconsin, USA. Their Cologuard was approved by the FDA in 2014. Cologuard is a non-invasive screening test for colorectal cancer. By analyzing fecal DNA and blood biomarkers, 92% of cancers and 69% of precancerous polyps were found in typical patients.
We hope that this invention will soon enter the clinic to provide early detection services for people at risk of liver cancer.
Reference material
[1] Exact Sciences' DNA blood panel detects early-stage liver cancer with 93% sensitivity
[2] Exact Sciences official website
Source: WuXi PharmaTech
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