The new generation of in-vitro diagnostics for cervical cancer
ScreenYu Gyn® is a product developed from GynTect®, the test for cervical cancer. As only one cancer marker is detected in the PCR, it is even easier to perform in the laboratory. For doctors and patients, there is no difference in handling and reliability.
The ScreenYu Gyn® test is based on the detection of DNA methylation in a human gene region. During the process of DNA methylation, methyl groups are attached to the DNA. These are always cytosines that are adjacent to a guanine, so-called CpG dinucleotides.
Only originally methylated DNA regions are amplified during PCR. The procedure is therefore also known as methylation-specific PCR (MSP).
The ScreenYu Gyn® test contains an internal control for reliable and robust performance. Positive and negative controls are also included.
Patient sample:
Preparation
Working time: 15 min
ThinPrep PreservCyt® (Hologic).
Bisulfite treatment:
Fixation of DNA methylation
Duration: 110 min
Working time: 25 min
Bisulfite treatment with the EZ DNA Methylation-Lightning Kit (Zymo Research).
Analytical PCR:
Detection of the marker region
Duration: 65 min
Working time: 20 min
ScreenYu Gyn PCR (TaqMan probe PCR).
Evaluation:
Data analysis
Working hours: 20 min
The data analysis for the evaluation of ScreenYu Gyn® is carried out using calculation software such as Microsoft Excel.
Precise result in just a few days
| Kit | PCR device | Kit size |
| SG001-46 | cobas z 480 Analyzer (Roche) CFX96 Real-Time PCR Detection Systems (Biorad) |
46 samples (up to 46 Samples per PCR run, up to 6 PCR runs) |
You can order ScreenYu Gyn® kits for the cobas® z 480 Analyzer or the CFX96 Real-Time PCR Detection Systems . The order button will take you to our contact form.
Our products are CE-IVD approved, and therefore fulfill all legal requirements for medical devices for in-vitro diagnostics of cervical cancer. Our company and our production are ISO 13485 certified.
Backround
If an HPV infection becomes chronic, this can lead to genetic instability of the cells. These cell changes can develop into precancerous lesions and eventually into cervical cancer. If cancer develops, changes occur in the DNA. This process is called methylation.
Women usually learn about their HPV infection or altered cells on the cervix through their regular cervical cancer screening at the gynecologist (HPV and Pap test). A nerve-wracking time then begins for the women affected. This is because further examinations (colposcopy) are necessary to determine whether the abnormalities are harmless or whether precancerous stages or cervical cancer have actually developed. It may even be necessary to decide whether the supposedly affected tissue needs to be removed (Conization). This is where ScreenYu Gyn® comes in: Using a swab sample from the cervix, the test quickly and reliably detects cervical cancer in its early stages.
ScreenYu Gyn® recognizes areas of the human genome that are only methylated during the development of cancer cells, therefore recognizing patients with malignant changes.
Positive ScreenYu Gyn® result: A malignant tissue change or even a carcinoma could be present. Invasive diagnostics and therapeutic action are advisable.
Negative ScreenYu Gyn® result: Cervical cancer is very unlikely at the time of the test. If dysplasia is present, it is highly unlikely to be malignant.
Order GynTect® or ScreenYu Gyn®
Do you have any further questions? Please use one of the below contact methods.
Löbstedter Str. 41
07749 Jena
Germany
Contact us if you have any further questions:
Photo credits
Hero Header: oncgnostics GmbH/ Eberhard Schorr
GynTect® at a glance: oncgnostics GmbH/ Eberhard Schorr
Graphics analysis: oncgnostics GmbH
Product image: oncgnostics GmbH / Eberhard Schorr
