Backtracking on past content:
On December 21 last year, an international academic journal [Frontiers in Molecular Biosciences] with an impact factor of 5.246 published a medical paper based on Aichangkang products, which was recognized by many experts.
Previous studies have shown that Aichangkang® dual-target fecal DNA assay has potential application value in the detection of colorectal cancer (CRC). This article describes the comprehensive performance of Aichangkang® in a multicenter clinical trial.
Recently, the results of the multi-center clinical trial research of Aichangkang® were published in the international academic journal【THE JOURNAL OF MOLECULAR DIAGNOSTICS】with an impact factor of 5.568, entitled 'Evaluating the Clinical Performance of a Dual-Target Stool DNA Test for Colorectal Cancer' Detection'.
Chinese name: 'Clinical performance evaluation of dual-target stool DNA test for colorectal cancer'
In this study, a double-blind case-control study was adopted, and a total of 1164 subjects were included in three independent hospitals, namely Peking Union Medical College Hospital, Zhongnan Hospital of Wuhan University, and the First Affiliated Hospital of Anhui Medical University, including 320 CRC patients, 148 adenomas, and interfering diseases. 396 cases and 300 healthy controls (below). The main indicators for judging the experimental results include sensitivity, specificity and accuracy.
method:
Methylation-specific PCR (MSP) was performed on all 1164 samples;
Sanger sequencing was performed on 375 samples;
Methylation-specific PCR testing was performed again on the 34 participants whose tumors had been removed.
Experimental results:
[Performance of CRC detection] The sensitivity of CRC detection was 95.31%, the specificity in normal controls was 96.67%, and the accuracy was 90.29%.
[Early detection rate performance] The sensitivity to advanced adenoma was 63.16%.
【Anti-interference performance】 When combined with interfering diseases, the specificity was 88.39%.
[Sanger sequencing verification performance] The average accuracy of methylation status of 375 samples verified by Sanger sequencing was 99.62%,
【Postoperative verification performance】34 participants underwent methylation test for the second time after surgical resection, with an accuracy rate of 94.12%.
1. [Overall performance of CRC detection] The detection sensitivity & specificity is high, and the early detection rate is high
MSP detection was performed on 320 CRC samples and 300 normal control samples and compared with the pathological results.
Experimental results:
The sensitivity of CRC detection was 95.31% (95%CI: 93.00%-97.63%), and the specificity in healthy normal controls was 96.67% (95%CI: 94.64%-98.70%);
The average sensitivity of early (I and II) CRC detection was 96.93%.
Experimental results:
Aichangkang® dual-target DNA detection has high sensitivity and specificity;
Aichangkang® dual-target DNA assay can more accurately detect early-stage adenomas.
2. [Anti-interference performance]: Aichangkang® dual-target DNA detection has a good ability to identify interfering diseases
The study enrolled 396 participants with common digestive disorders classified as interfering disorders. The positive detection rate of interfering diseases was 6.70% (n=27), and the specificity was 93.15% (n=367).
Data results: The sensitivity and specificity of CRC detection were 95.31% and 96.67%, respectively, and the accuracy was 90.29%. When combined with interfering diseases, the specificity was 88.39%.
Experimental conclusion: Aichangkang® dual-target DNA detection has good identification of interfering diseases.
3. [Comparison with Sanger sequencing results] The consistency is 99.62%
The methylation status of SDC2 and TFPI2 in 375 samples was verified by Sanger sequencing. By sequencing the MSP products, it was observed that the concordance between the MSP results and the sequencing results for SDC2 was 100% (kappa =1.00), and the concordance between the MSP results and the sequencing results for TFPI2 was 98% (kappa =0.98) , with an average accuracy of 99.62%.
Data result:
Experimental conclusion: Aichangkang® dual-target DNA detection method can detect abnormal gene methylation very accurately.
4. [Postoperative patient follow-up] The postoperative detection accuracy rate is 94.12%
Thirty-four patients were followed up and their stool samples were tested a second time within 2 months after surgery, and the results were as follows
|
| Before resected |
|
| Positive | Negative |
After resected | Positive | 2 | 0 |
Negative | 28 | 4 |
Data results: 4 cases of CRC confirmed as false negative before operation were negative after retest, and the remaining 28 cases of MSP-positive CRC were negative after operation. The accuracy was 94.12% (32/34) except for 2 CRCs that were not as expected.
Experimental conclusion: Aichangkang® dual-target DNA detection method can be well used for postoperative monitoring of patients.
In recent years, Emerson Life Technology has developed a series of products in the field of early diagnosis of multiple high-incidence malignant tumors, covering digestive system tumors (intestinal cancer, gastric cancer, liver cancer, esophageal cancer, pancreatic cancer), gynecological tumors (cervical cancer, endometrial cancer) cancer), urinary system tumors (bladder cancer), pan-cancer species, etc.
With outstanding product performance, Amisen Life Technology has won four rounds of financing of hundreds of millions of yuan and strong support from governments at all levels, and has won various honorary titles.
Behind the excellent clinical performance indicators and technology platform is the unswerving benevolence of doctors, escorting the life and health of the public is the persistent pursuit of Emerson Life Technology!
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About Emerson Life Technology
Emerson Life Technology focuses on the early diagnosis and screening of high-incidence malignant tumors, providing digestive system tumors (intestinal cancer, gastric cancer, liver cancer, esophageal cancer, pancreatic cancer), gynecological tumors (cervical cancer, endometrial cancer), urinary system tumors (bladder cancer) Cancer), pan-cancer species and other high-incidence malignant tumor genetic testing services.
The company has been based on local development for many years, and its core technology is independent and controllable. After several years of accumulation, a diversified product detection system with methylation navigation technology as the core has been established; after tens of thousands of clinical sample verifications, the screening sensitivity and specificity have reached the industry-leading level! The company has applied for 55 patents and published more than 10 cutting-edge research results. It has become one of the few multi-type cancer screening service providers in the world and a tumor early diagnosis and early screening enterprise that licenses external technology license-out.