Significant Role of miRNA7TM Test Kit
in Liver Cancer Efficacy Detection and Risk Warning
PRODUCTS
miRNA7TM Test Kit
(PCR Fluorescent Probe Method)
- ➤ miRNA7TM Test Kit (PCR fluorescent probe method) China National Instruments Injection Standards (CNIS) 20173403299
- ➤ China's first NMPA-approved molecular test for liver cancer, and has been used in clinical applications
- ➤ Included in many authoritative guidelines and consensus such as "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)", and awarded with the Second Prize of National Science and Technology Progress in 2020.
Technical characteristics
- ● Effective detection of AFP (alpha-fetoprotein)-negative hepatocellular carcinoma● Very early liver cancer detection rate 30% higher than traditional methods such as AFP● Indicates hepatocellular carcinoma risk 11.5 months earlier than imaging, on average
- More EffectiveThe sensitivity of AFP negative liver cancer patients is as high as 77.7%, which is helpful for the early diagnosis of AFP negative liver cancer.
- More Accurate7 genes are combined for specific capture detection, the detection rate of early-stage liver cancer is increased by 30% compared to traditional methods
- Earlier DetectionIndicates hepatocellular carcinoma risk 11.5 months earlier than imaging, on average
- More ConvenientNoninvasive testing, facilitating dynamic and continuous monitoring; Low sample requirements, only 3mL of blood sample needed.
clinical significance
- 01
Dynamic Detection of Efficacy in Primary Liver Cancer
- 02
Early Warning of Primary Liver Cancer Risk
Introduction
- About miRNAMicroRNAs (miRNAs) are a class of non-coding, single-stranded, small-molecule RNAs that are widely found in eukaryotic cells and range from 19 to 24 bases in length. miRNAs have been recognized as being implicated in normal physiology and in the pathogenesis of disease.
- Relationship between miRNAs and Tumors
Human cancers are characterized by several features, including persistent proliferative signaling, evasion of growth inhibition, resistance to cell death, replicative immortality, activation of invasion and metastasis, and induction of angiogenesis. Studies in recent decades have identified that miRNAs are aberrantly expressed in tumors, and dysregulated miRNAs may influence one or more cancer characteristics of tumorigenesis and progression.
Mature miRNAs are very stable in body fluids and have very high specificity across different cancer states, which allows miRNAs to serve as potential non-invasive tumor markers for human cancers.
- miRNA and Liver Cancer
Patients with hepatocellular carcinoma have been reported to have a specific plasma microRNA expression profile.
Zhongshan Hospital of Fudan University utilized high-throughput microarrays to screen and validate a model consisting of seven microRNAs (miR-21,miR-26a, miR-27a, miR-122, miR-192, miR-223, miR-801) in 934 plasma samples (controls included healthy individuals, chronic hepatitis B patients, and cirrhotic patients), which could accurately differentiate hepatocellular carcinoma from controls.
Product Overviews
miRNA7TM is used for the early diagnosis and dynamic efficacy monitoring of hepatocellular carcinoma (HCC) by detecting the expression of a set of 7 microRNAs in human plasma and analyzing them with logistic regression, obtaining a comprehensive assessment value, comparing it with a threshold value, and determining the negativity and positivity (a positive value is considered to be positive when the comprehensive assessment value is ≥-0.5, and a negative value is considered to be negative when the value is <-0.5).
Safe and Non-invasive
3 ml peripheral whole blood (required to be free of coagulation and hemolysis).
Technical Advantages
Highly efficient target capture by magnetic bead-coupled specific probes and highly specific target detection by optimized design of stem-loop primers and specially modified probes.
Significantly More Effective than AFP
Sensitivity of 76.48%, specificity of 90.03%, national multicenter large-sample clinical trial data (1,812 cases); among the 1,282 AFP-negative samples, the sensitivity reached 77.16% and specificity reached 91.22%.
Early Detection
Detecting cancer signals at the microscopic molecular level enables earlier detection of < 2cm very early stage liver cancer.
Report Time
Equipped with automated pipetting workstation and automated result analysis software, report issued within 6h.
PROCESS
One-stop solution, automated development of miRNA7TM-based reagents for "sample - in - result-out", the only NMPA-approved liquid biopsy product for HCC efficacy monitoring
· Throughput of 24-192 samples/run to meet the needs of different volumes of detection.
· Nucleic acid purification and PCR system construction are fully automated, with accurate and stable results.
· Medical device registration (in progress).
· Automatically recognizes and processes output results and generates reports.
· Can be interfaced with systems such as Lims and results are entered automatically.
· Data tracking, summary statistics.
Clinical applications
miRNA7TM Test Kit is available at ......
Dynamic monitoring of efficacy in patients with hepatocellular carcinoma
Risk warning for hepatitis B, cirrhosis
and other liver cancer risk groups
Adjuvant determination in a population with
difficulty in distinguishing between benign and malignant tumors
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Case 1
Patient information: A
Sex: male. Age: 64
Case Status
In May 2018, physical examination revealed a large occupancy in the right anterior lobe, which was considered malignant.In June 2018, "segmental hepatectomy" was performed under general anesthesia in the Department of Hepatology. Surgical pathology: hepatocellular carcinoma. Postoperative imaging, AFP and miRNA7TM follow-up were performed.Case Discussion
By June 2019, after 6 follow-up visits, no recurrent metastatic foci were found on imaging, and both AFP and miRNA7TM indicators were negative, suggesting that the patient's condition was good after surgery, and it was recommended to continue to follow up and monitor the condition; in July 2019, the AFP indicator was negative, and the miRNA7TM indicator (1.48) was greater than the comprehensive assessment value (-0.5), which was positive, suggesting that the patient's condition was recurrent after surgery. The patient was diagnosed with recurrence of 9-mm-diameter hepatocellular carcinoma by imaging, and radiofrequency ablation was selected for treatment. After re-treatment, the patient was followed up until December 2019, and the miRNA7TM index was negative, and no recurrent metastasis was detected by imaging. -
Case 2
Patient information: B
Sex: male. Age: 55
Course of the Disease and Treatment Results
The patient had a history of cirrhosis for more than 20 years, and on July 27, 2020, whole blood samples were collected at regular follow-up, and were tested for miRNA7TM, AFP, AFP-L3, and PIVKA II, respectively. Among them, miRNA7TM (-0.37) was greater than the comprehensive assessment value (-0.5), suggesting the risk of deterioration. on July 28, 2020, MRI examination suggested an abnormal signal in the S7 segment of the liver, and primary liver cancer could not be excluded. After the patient actively improved the relevant examinations, excluding contraindications to surgery, he underwent special hepatic segment + cholecystectomy + extensive intestinal adhesion release under general anesthesia on August 5. The operation was smooth, and the postoperative pathology confirmed the diagnosis of hepatocellular carcinoma, grade III.
