Rising Incidence and Burdensome Diagnostic Pathways

Endometrial cancer is the most common gynecological malignancy in Germany. Around 11,000 women are diagnosed with it every year , and the incidence continues to rise.¹

Abnormal uterine bleeding is currently investigated via transvaginal sonography and, in case of abnormal findings, via hysteroscopy with curettage.

These procedures are established, but their specificity (35–46%)²,³ is limited and they involve invasive procedures under general anesthesia.

The result: 97% of patients with postmenopausal bleeding do not have cancer,² but often still have to undergo invasive examinations with unnecessary burden, risk and costs.

  • ca. 11,000

    Endometrial Cancer Diagnoses Per Year¹

  • 35 - 46%

    Specificity of Transvaginal Sonography²,³

  • 97%

    of the Women With Abnormal Bleeding Do not Have Cancer²,⁴
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WID®-easy: Evidence-based Precision Instead of Invasive Routine

The WID®-easy (WID-qEC) test analyzes DNA methylation markers (ZSCAN12 & GYPC) from a simple cervicovaginal swab.

These epigenetic markers are cancer-specifically methylated and enable the objective detection of tumor DNA in cervicovaginal material – even in endocervical or sonographically occult carcinomas.

Clinical data (EPI-SURE study, Lancet Oncol. 2023): ²

  • Sensitivity: 91%
  • Specificity: 97%
  • Positive predictive value (PPV): 50%
  • Negative predictive value (NPV): > 99%
  • Clear results in 98% of samples

  • High Diagnostic Accuracy

    It protects 9 out of 10 women from a
    invasive procedure

  • Minimally Invasive & Painless

    No surgical intervention required – simple swab, quick evaluation

  • Standardized & Objective

    Automated laboratory analysis with a clearly defined ∑PMR value, independent of user experience

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Rapid Clarity In Cases of Suspected Endometrial Cancer

  • In cases of abnormal bleeding after menopause, transvaginal ultrasound remains the primary diagnostic procedure. However, its specificity is limited, and abnormal findings often lead to invasive procedures even when no malignancy is present.

    The WID®-easy test helps you to objectively verify sonography findings and to assign only those patients to immediate invasive diagnostics who actually have an increased risk.

    Studies have shown that instead of 20 procedures in 40 patients, only 2 are required with WID®-easy, without overlooking any carcinomas.

    This means for your practice:

    • More precise triage for patients with abnormal bleeding
    • More efficient use of resources through fewer unnecessary operational investigations.
    • Increased patient satisfaction through clear, evidence-based decision-making processes.


    Ultrasound remains indispensable and is optimally complemented by WID®-easy . This method provides objective molecular evidence where previously only morphological assessments were possible.

Who Is the WID-easy Test Suitable For?

The test is indicated for peri- and postmenopausal women with abnormal uterine bleeding (AUB).

It is particularly suitable if:

  • Repeated bleeding or unclear sonography findings exist,
  • the cytological examination is unremarkable or inconclusive,
  • An invasive diagnostic procedure (hysteroscopy or curettage) is still being considered.
  • to rule out the presence of aggressive serous carcinomas, which often do not present with sonographic abnormalities.

The test thus serves as an objective decision-making aid in triage and can help to avoid unnecessary surgical interventions.

How Is the Sample Taken?

The sampling procedure is similar to a Pap smear, uncomplicated and virtually painless:

  1. Taking a cervicovaginal swab using a FLOQSwab.
  2. Use of the eNAT transport medium for DNA stability.
  3. Sending the sample to our medically supervised analysis laboratory.

Important:

  • Ideally, the sample should be taken before other vaginal examinations.
  • No vaginal sex and no intravaginal medication in the 24 hours prior to collection .

How Exactly Does the WID-easy Test Work?

The WID®-easy test is based on the analysis of DNA methylation in cervicovaginal smears. It detects epigenetic changes in two specific gene regions ( ZSCAN12 and GYPC ) associated with endometrial and endocervical carcinomas. An additional gene (COL2A1) assesses whether the sample contains sufficient human DNA.

These DNA changes are quantified using real-time PCR and expressed as the ∑PMR value (Percentage of Methylated Reference) .

  • A value of ≥ 0.3 is considered positive → high risk, invasive investigation recommended.

  • A value of < 0.3 is considered negative → low risk, conservative control is sufficient.

How Quickly Will the Result Be Available?

After the sample has been taken and sent to the partner laboratory, the result is usually available within 14 days .

The evaluation is fully automated using real-time PCR , thus ensuring a standardized and objective result.

The laboratory report contains:

  • the ∑PMR value (Percentage of Methylated Reference) ,
  • a clear classification of the test result (positive / negative),
  • as well as an action-oriented recommendation for further diagnostic procedures.

This allows the assessment to be made significantly faster and more structured – a clear advantage over the previous combination of ultrasound, cytology and repeated follow-up examinations.

How Do I Interpret the Result?

A negative result means with a high probability that there is no endometrial or endocervical carcinoma (negative predictive value: >99%).

If the test is positive , hysteroscopy with fractional curettage is recommended. If the WID-easy test is positive and endometrial carcinoma is absent, cervical carcinoma should also be ruled out (cervical carcinomas are also WID-easy positive).

Which Studies Prove it's Effectiveness?

The performance of the WID®-easy (WID-qEC) test has been proven by a number of independent, internationally published studies.

Among the most important are:

1) Evans et al., Lancet Oncology , 2023

The prospective EPI-SURE study compared the WID-qEC test with transvaginal ultrasound in women with abnormal uterine bleeding. The study showed that the test reliably detects both endometrial and endocervical carcinomas and can drastically reduce the number of unnecessary invasive procedures.

  • Sensitivity 91%, Specificity 97%
  • Significant reduction in unnecessary hysteroscopies while maintaining the same detection rate.

2) Illah et al., International Journal of Cancer , 2024

In this multicenter study, the WID-qEC test was validated in various clinical settings and with different sampling methods (cervical, vaginal). The results confirmed the high performance and robustness of the test regardless of the sample source.

3) Schreiberhuber et al., International Journal of Cancer , 2023

This study investigated the use of the test in everyday clinical practice. It showed that the WID-qEC test also detects tumors that are not visible on ultrasound, particularly endocervical carcinomas.

  • Detection of sonographically occult carcinomas
  • High applicability in routine diagnostics

4) Hillemanns et al., Gynecologist , 2025

This review summarizes the current evidence and guideline recommendations. It classifies the WID-easy test as a promising tool for the diagnosis of patients with peri- and postmenopausal bleeding.

  • Recommendation for integration into the diagnostic pathway (DNA methylation prior to ultrasound)
  • Clinical evaluation: high validity, objective complement to sonography

5) Herzog et al., Journal of Clinical Oncology , 2022

In this validation study, the test was evaluated for the first time in several cohorts with a total of over 1,000 women. It consistently showed high sensitivity and specificity across all populations.

  • Evidence of high diagnostic precision in independent cohorts
  • Consistently high sensitivity up to 12 months before histological diagnosis
Portraitfoto von Dr. Annette Buhlmann

Use WID®-easy in Your Practice – Safe, Simple, Evidence-based

Request your free practice test kit now and learn about molecular diagnostics for the investigation of abnormal uterine bleeding.

For greater diagnostic certainty, less stress and improved care for your patients.

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References

1) Robert Koch Institute and the Association of Population-Based Cancer Registries in Germany (2023). Cancer in Germany for 2019/2020, 14th edition. 2) Evans I, Reisel D, Jones A, Bajrami A, Nijjar S, Solangon SA, Arora R, Redl E, Schreiberhuber L, Ishaq-Parveen I, Rothärmel J, Herzog C, Jurkovic D, Widschwendter M. (2023). Performance of the WID-qEC test versus sonography to detect uterine cancers in women with abnormal uterine bleeding (EPI-SURE): a prospective, consecutive observational cohort study in the UK, Lancet Oncol, 24(12):1375-1386. doi:10.1016/S1470-2045(23)00466-7. 3) Goldstein SR, Khafaga A (2021). Ability to successfully image endometrium on transvaginal ultrasound in asymptomatic postmenopausal women. Ultrasound Obstet Gynecol.58(4):625-629. doi: 10.1002/uog.23667. 4) Nicholson, Brian D et al. (2023). Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study, The Lancet Oncology, 24(7), 733 - 743. doi.org/10.1016/S1470-2045(23)00277-2.