Mía by XytoTest® a New Alternative in Cervical Cancer Prevention

A patented, clinically proven three-step system for comprehensive Cervical Cancer prevention


Device for cervicovaginal sample-taking without a speculum

Real-time PCR molecular assay to detect 14 genotypes in HR-HPV DNA (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68)

Triage to test HR-HPV-positive samples for E6/E7 mRNA in 7 HR-HPV genotypes (16, 18, 31, 33, 45, 52, and 58)

HR-HPV and the Link With Cervical Cancer

What is HPV?

1 Centers for Disease Control and Prevention

HR-HPV and Cervical Cancer

Having high-risk Human Papillomavirus is NOT THE SAME as having Cervical Cancer. 

Most HPV infections are asymptomatic and short-lasting and are cleared by the body’s own immune system. However, infections caused by one or more of the 14 high-risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) can be long-lasting and lead to precancerous lesions, which can develop into Cervical Cancer if left untreated.

Cervical Cancer is the only cancer that is 100% preventable.

World figures: 2

2 World Health Organization. International Agency for Research on Cancer IARC. December 31, 2018

Myths and Facts

Triage E6/E7 mRNA Tumor Markers

Triage – with E6/E7 mRNA biomarkers that detect seven specific HR-HPV genotypes – helps women avoid unnecessary treatment. 3 Overexpression of E6/E7 oncoproteins in active HR-HPV infections also guides decisions regarding future disease risk. 4

3 Massimo Origoni et al, Cancer Medical science. Milan, Italy April 29, 2015

4 Virol J. 2018 Mar 27;15(1):52. doi: 10.1186/s12985-018-0957-z.

View Research & Development

A negative test result does not confirm the absence of cervical cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False-positive and false-negative results can occur.

SAMPLE TAKING WITHOUT A SPECULUMMía by XytoTest®: Instructions for Use

This procedure can be performed by a healthcare professional or as a self-sampling technique by the patient herself.

  • 1

    Check the barcodes.

    Check that the barcodes match on all kit items (informed consent, test tube, and safe storage bag).

  • 2

    Fill out the informed consent form.

    After completing all the fields in the informed consent form, wash hands and/or put on gloves before using the device.

  • 3

    Place the patient in the lithotomy position.

    With the patient lying on her back with her knees flexed, take the device out of the packet, remove the protective cap, and discard it.

  • 4

    Insert the device.

    Separate the labia and without a speculum carefully insert the device into the vagina until the rim of the device base touches the skin. Rotate the device three times (through 360°) in a clockwise or counterclockwise direction.

  • 5

    Remove the device.

    Carefully withdraw the device from the vagina and immediately place it in the transport tube provided. Close the tube. Place the tube and completed informed consent form in the safe storage bag.

  • 6

    Send the sample to the lab.

    Send the sample for testing as soon as possible, following the laboratory’s shipping instructions.

  • See How to Use it


Do young women get HPV too?

Yes. More than two-thirds of young adult women get HPV within two years of becoming sexually active.

Is Mía by XytoTest® suitable for my patients?

Mía by XytoTest® is a molecular test suitable for all sexually active women over the age of 25. 

Is Mía by XytoTest® a painful test?

No. Mía by XytoTest® is a user-friendly device that is not painful or even uncomfortable.

What are the benefits of using Mía by XytoTest® without a speculum?

Mía by XytoTest® is designed for use without a speculum to achieve a more even, representative sample of the whole of the vagina, and to collect more cervicovaginal cells.

Can Mía by XytoTest® be used in menstruating women?

Yes. Mía by XytoTest® can be used during a woman’s period, although avoiding the first three days of heavy blood flow will prevent getting clots in the sample.

Are there any contraindications to performing Mía by XytoTest®?

Yes. Ovules, gels, creams, lubricants, and vaginal douches should not be used for 24 hours prior to the sampling procedure.

What does a Mía by XytoTest® result show?

The result indicates the presence or absence of one or more of the 14 HR-HPV genotypes. Genotypes 16 and 18 are reported separately, while the 12 other genotypes are reported as a pool. 

If the HR-HPV DNA test is positive, a second test is performed to identify E6/E7 mRNA in HR-HPV genotypes 16, 18, 31, 33, 45, 52, and 58. This co-test shows whether the HR-HPV infection has already triggered oncogenic activity.

What does it mean if a test is positive for HR-HPV in the DNA test but then negative for E6/E7 mRNA?

Having an HR-HPV infection is not the same as having Cervical Cancer. A positive HR-HPV test and a negative E6/E7 mRNA test simply warns that the virus exists. A healthcare professional should assess the results together with other tests and the patient’s medical record.

What do positive results for both HR-HPV and E6/E7 mRNA mean?

A positive result in both tests shows that the HR-HPV infection has triggered oncogenic activity and that this is not simply a passing infection. A healthcare professional should assess the results together with other tests and the patient’s medical record.

How often should patients have a Mía by XytoTest® test?

A test is recommended every 3-5 years for patients with negative molecular tests, known medical records, and a single sexual partner. However, healthcare professionals should decide on test frequency.

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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Have Questions? Our team is happy to answer any questions you may have.

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