The GynTect® test is based on the detection of DNA methylation in human gene regions. During the process of DNA methylation, methyl groups are attached to DNA. These are always cytosines located next to guanines (‘CpG dinucleotides’).
Only originally methylated DNA regions are amplified in the PCR. Therefore, this procedure is also called methylation-specific PCR (MSP).
For a high-quality workflow, the GynTect® assay includes several internal controls. Furthermore, positive and negative controls are included.
Patient sample:
Preparation
Hands-on time: 15 min
Smear medium: STM™ (Qiagen) or ThinPrep PreservCyt® (Hologic).
Bisulfite treatment:
Fixation of DNA methylation
Duration: 70 min
Hands-on time: 25 min
Bisulfite treatment with the EpiTect® Fast Bisulfite Kit (Qiagen).
Analytical PCR:
Detection of Marker Regions
Duration: 100 min
Hands-on Time: 35 mins
GynTect®-PCR: 7500 Real-time PCR System (Applied Biosystems™);
cobas® z 480 Analyzer (Roche Diagnostics).
Evaluation:
Data Analysis
Hands-on time: 30 min
The data analysis for the evaluation of GynTect® is carried out using calculation software such as Microsoft Excel.
GynTect® in brief – a quick overview (48 seconds)
How to perform GynTect® – step by step trough the test procedure (7:25 minutes)
| Kit | PCR device | Kit Size | Samples to be analysed simultaneously |
|---|---|---|---|
| GT003-10 | cobas® z 480 Analyzer (Roche) | 10 samples | 10 |
| GT003-06 | cobas z 480 Analyzer (Roche) | 6 samples | 1-6 |
You can order GynTect® kits for the the cobas® z 480 Analyzer. By clicking the order button, you can access our contact form.
Our products are CE IVD-approved. Our company and our production facilities are ISO 13485-certified and therefore meet all legal requirements for medical devices for in vitro diagnostics.
An existing infection with HPV may lead to genetic instability of the infected cells and eventually cervical cancer. In the course of carcinogenesis, changes (methylation) occur in the DNA.
If the Pap test is abnormal or the HPV test is positive in cervical cancer screening, the affected patient is suddenly in an exceptional situation, as both tests indicate a potential cancer. In many cases, however, no malignant disease is present and the positive test result was a false alarm. For definitive medical clarification, further examinations are necessary, such as a colposcopy, and if necessary, a colposcopy-guided biopsy. In case of abnormalities, the allegedly affected tissue is often removed prematurely.
If there is a positive GynTect® result, a malignant precursor or even cancer is very likely. Further steps such as diagnostics assisted by colposcopy and surgical therapies are recommended.
With a negative GynTect® result, a cancer diagnosis could be excluded at the time of testing. If there was an abnormal Pap test or HPV infection prior to the test, it is recommended to observe them further in a watchful waiting strategy.
Based on available study data GynTect® provides a clear indication of the malignancy status in patients with abnormal Pap smear: In all previous studies, GynTect® was able to detect all cervical cancer cases (sensitivity = 100 %).
In cytologically inconspicuous patients, GynTect® is only rarely positive (specificity = 96.6 %). Cancer develops via the histopathologically defined dysplasias CIN1, CIN2 and CIN3, for which the detection rate of GynTect® increases continuously. This indicates a prognostic value of GynTect® cancer markers.
