In vitro diagnostics for cervical cancer

GynTect®

GynTect® is employed in the in vitro diagnosis of cervical cancer. This molecular biological test is based on the detection of DNA methylation in human gene regions. The detection of the GynTect® markers is done using a real-time polymerase chain reaction (PCR).

Implementation of the analysis

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’).

The analysis of the patient sample using polymerase chain reaction contains two steps:

  1. First, methylation is fixed by bisulfite treatment.
  2. Subsequently, specific regions of the genome are analysed by polymerase chain reaction (PCR), and an evaluation is carried out using spreadsheet software.

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® Tutorial

GynTect® in brief – a quick overview (48 seconds)

How to perform GynTect® – step by step trough the test procedure (7:25 minutes)

GynTect®-Kits

KitPCR deviceKit SizeSamples to be analysed simultaneously
GT012-107500 Real-Time PCR-System (Life Technologies by Thermo Fisher Scientific)10 samples10
GT012-067500 Real-Time PCR-System (Life Technologies by Thermo Fisher Scientific)6 samples1-6
GT003-10cobas® z 480 Analyzer (Roche)10 samples10
GT003-06cobas z 480 Analyzer (Roche)6 samples1-6

When ordering, please note that our kits are approved for different PCR systems. You can order GynTect® kits for the 7500 Real-Time PCR System or 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.

  • Feasible within one working day

  • Applicable on 7500 Real-Time PCR System and cobas® z 480 Analyzer

  • Data evaluation with integrated guided calculation software

GynTect® detects malignant transformations

Background

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.

GynTect® detects six regions in the human genome which are only present in methylated form during the growth of cancer cells. Using this technique, GynTect® determines malignant changes in patients.

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.

Study data

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.

Study data GynTect

Publications

Publications