PreTect HPV-Proofer 7®The Most Effective e6/e7 mRNA Test

  • Not all HPV genotypes carry the same risk. The goal is to find the ones that trigger Cervical Cancer and pre-empt it.
  • The E6/E7 mRNA test with the strongest predictive value. 1
  • High specificity triage in ASC-US and grade 1 cervical intraepithelial neoplasia (CIN 1) cytology diagnosis.
  • Identification of precursor lesions most likely to progress to invasive cancer.
  • Higher specificity than other tests, resulting in accurate patient management and avoiding unnecessary treatment.
  • Only for use by healthcare professionals.
  • Intrinsic sample control to check specimen quality and detect factors inhibiting amplification.

1 “HPV E6/E7 mRNA test for the detection of high-grade cervical intraepithelial neoplasia”

E6/E7 mRNAand the Link to Cervical Cancer

  • The main cause of Cervical Cancer is the presence of E6/E7 oncoproteins in HPV.
  • More than 90% of cervical cancer cases worldwide are caused by HPV genotypes 16, 18, 31, 33, 45, 52, and 58. 1
  • Cervical Cancer is the only cancer that is 100% preventable, if HR-HPV is detected early.
  • The optimal detection strategy requires high specificity and accurate individual patient management to minimize unnecessary treatment due to false positives.

1 WHO.

NASBA TECHNOLOGY:Nucleic Acid Sequence-Based Amplification

PreTect HPV-Proofer 7® is based on NASBA technology, an enzymatic amplification process that can amplify and detect RNA even in the presence of DNA. Unlike PCR, an amplification run is performed under isothermal conditions at 41°C, achieving a fast result.

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What is the added value of using PreTect HPV-Proofer 7® compared to other DNA/RNA tests?

PreTect HPV-Proofer 7® is the assay with the highest specificity and positive predictive value on the market today 1. This means that PreTect HPV-Proofer 7® can reduce the cost of follow-up – and the number of women requiring referrals and additional tests – by more than 70%.

1 Derbie A, Mekonnen D, Woldeamanuel Y, Van Ostade X, Abebe T. (2020). “HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review”.

What about the HR-HPV types not detected by PreTect HPV-Proofer 7®?

PreTect HPV-Proofer 7® identifies the 7 most common genotypes related to Cervical Cancer causing more than 90% of all cases of Cervical Cancer in the world. Therefore, there is only a very small chance of developing Cervical Cancer caused by one of the other 7 uncommon HR-HPV genotypes.

Is PreTect HPV-Proofer 7® clinically validated?

PreTect HPV-Proofer 7® is clinically validated according to the EU IVD regulations.

Molecular TechnologyOur Products

We develop medical devices and safe, state-of-the-art molecular technologies that empower you to take control of your health through prevention.

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    Medical Devices

    User-friendly. Safe.

    The Mel-Mont Medical portfolio offers patented and versatile products for HR-HPV-related cancer prevention.

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    In Vitro Diagnosis

    Experience. Reliability.

    Our PreTect division offers molecular assays for nucleic acid amplification, along with an ISO 13485-certified HPV-mRNA molecular laboratory service.

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    Sample Prep Reagents

    Efficiency. Cost-effectiveness.

    Our sample preparation reagents portfolio includes sample preparations for molecular testing and a transport medium.

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