IUterusure

DNA Methylation Detection Kit for Endometrial Cancer (cervical exfoliated cell)

  • Endometrial cancer is one of the three major malignant tumors of female reproductive system.
  • Ranked first among gynecological tumors in developed countries.
  • By 2023, there are no guidance-recommended screening methods for endometrial cancer.
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Sensitivity
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Specificity
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Current methods have limited sensitivity or are highly invasive

Method
Advantage
Limitation

Hematology

Easy sampling

  • There are no specific serum markers in hematology and no routine monitoring and screening indicators.
  • Some patients may have abnormalities in CA125, CA19-9, CA153 or HE4

Transvaginal

ultrasound

Non-invasive and simple

  • Vaginal ultrasound has limited sensitivity in diagnosing endometrial cancer and precancerous lesions in premenopausal women.
  • Vaginal ultrasound cannot reliably distinguish between benign and malignant lesions
  • Not recommended as a stand-alone screening method for endometrial cancer
Microhistopatholog ical examination

Lesions can be visualized

  • It is easy to cause insufficient material collection, making diagnosis difficult and resulting in false negatives.
  • High requirements for pathologists
  • Low satisfaction with the collection of benign intrauterine lesions such as uterine fibroids and endometrial polyps

Cytologic

examination

The operation is simple, can effectively reduce endometrial injury, reduce the risk of uterine perforation and uterine infection
  • making diagnosis difficult cell smears
  • Lack of strict endometrial cytology diagnostic standards unanimously recognized by cytologists
  • Changes in the endometrium are related to hormone levels, and the time of collection of cytology examinations will also affect the judgment of the results.
Hysteroscopic localiza-
tion biopsy or curettage

Gold standard,

high accuracy

  • Invasive examination
  • Multiple dilation and curettage may cause postoperative complications and certain damage to the uterus.

Can cervical exfoliated cells detect endometrial cancer?

Endometrial exfoliated cells will accumulate in the uterine cavity, cervical canal and cervix over time. A small amount of endometrial exfoliated cells can be obtained by taking cervical exfoliated cells, and endometrial cancer can be screened through highly sensitive detection methods such as DNA methylation.

Studies have shown that cervical exfoliated cell gene methylation detection shows good effectiveness in endometrial cancer screening,and in comparison with gene mutations, it is more suitable for endometrial cancer screening.(As shown in the following figure).

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Kit Components of IUterusure

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Cell-direct Bisulfite Modification Kit

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DNA Methylation Detection Kit for Endometrial Cancer

Brand Name IUterusure
Specimen cervical exfoliated cell
Intended Use The kit is intended for in vitro qualitative methylation detection of UCECM19 and UCECM22 genes in cervical exfoliated cells of the population at high risk of endometrial cancer.
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Advantage of IUterusure

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Simple sampling

IUterusure can be performed on the same sample (self-sample or physician/ gynecologist collected) as the primary screening HPV test.

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Small sample volume

Use 100-200ul exfoliated cells as sample type.

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High accuracy

The sensitivity for detection of cancer is 98.36%, the specificity is 92.59%.

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Easy operation

IUterusure can be performed on the mainstream brand qPCR machine.

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Avoid over-treatment

Provide a non-invasive screening method before diagnostic curettage to reduce unnecessary curettage and reduce the potential risk of curettage.

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Reduce anxiety

IUterusure provides test negative patients with peace of mind that they have a low short-term risk of Endometrial cancer.

For People

1.High risk group:

Patients with Lynch syndrome, those with third-degree relatives who have Lynch syndrome but have not undergone related genetic testing, and those with a family history of endometrial cancer or colon cancer.

2.People at increased risk:

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Lifelong childlessness or primary infertility

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Long-term treatment with tamoxifen (especially in patients >50 years old or postmenopausal who are still taking tamoxifen)

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Age ≥45 years old, combined with diabetes

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Obesity, body fat index (BMI) ≥30 kg/m²

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Polycystic ovarian syndrome

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History of estrogen use without progesterone antagonism

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Late menopause (>55 years old)

3.Other people who are willing to undergo endometrial cancer screening, such as menopausal people.

Testing Procedures

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Sample collection

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Pretreatment and extraction

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Bisulfite conversion and purification

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qPCR procedure

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Analysis and Report

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Sample collection

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Pretreatment and extraction

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Bisulfite conversion and purification

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qPCR procedure

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Analysis and Report

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