EndomKIT®

Early Diagnosis of Endometriosis

EndomKIT® is an innovative, CE-certified in vitro diagnostic test intended for women with suspected endometriosis. It combines laboratory analysis of specific biomarkers with the patient’s clinical data and provides physicians with valuable support in making diagnostic decisions. It can also serve as an important resource for women when deciding on next steps and appropriate treatment.

Key Benefits

  • A Noninvasive Diagnostic Approach
  • Support for Earlier Diagnosis of Diseases
  • High specificity of the results
  • Combination of laboratory and clinical data
  • A useful supplement to standard diagnostic methods

What is endometriosis?

Endometriosis is a chronic gynecological condition in which tissue similar to the uterine lining is found outside the uterine cavity. The condition is associated with chronic inflammation and can cause:

  • painful menstruation,
  • chronic pelvic pain,
  • pain during sexual intercourse,
  • fertility problems.

Endometriosis affects approximately 5–10% of women of reproductive age. It occurs in up to 50% of women suffering from chronic pelvic pain. Nevertheless, the diagnosis is often delayed by several years.

Current Diagnostic Options

Today, the diagnosis of endometriosis is based primarily on:

  • clinical symptoms,
  • a gynecological exam,
  • ultrasound examination,
  • magnetic resonance imaging (MRI).

Definitive confirmation of the diagnosis often requires laparoscopy with tissue sampling for histological examination. The invasive nature of this procedure is one of the factors that can lead to a delayed diagnosis.

 

How does EndomKIT® work? 

EndomKIT® combines:

 

Laboratory Analysis of Biomarkers

  • BDNF (Brain-Derived Neurotrophic Factor)
  • CA125 (Cancer Antigen 125)

The Patient's Clinical Data

The diagnostic algorithm includes six clinical data points obtained through a standardized questionnaire.

 

The result is:

✅ Positive result – supports the suspicion of endometriosis

or

✅ Negative result – The test did not confirm endometriosis.

Test results must always be interpreted in the context of other clinical and imaging studies.

Clinical Validation

In a validation study, EndomKIT® demonstrated:

  • 100% specificity

The primary goal of the development was high specificity, which makes it possible to reliably identify patients with a high probability of the disease. The results remained consistent even in the presence of other conditions that may complicate the diagnosis.

Examination procedure based on the use of the EndomKIT test

Contents of the Set

EndomKIT® (REF 780001) obsahuje:

  • ELISA kit for 48 tests,
  • reagents for the determination of BDNF and CA125,
  • access to the diagnostic algorithm,
  • Instructions for use.

The procedure was validated, among other things, on the open ELISA system DYNEX® DS2.

Applications

EndomKIT® is intended for:

  • specialized centers that diagnose endometriosis,
  • gynecological clinics,
  • reproductive medicine centers,
  • clinical laboratories.

 

Do you need more information?

The company Astra Diag s.r.o. provides expert consultation, technical support, and information on implementing the EndomKIT® test into laboratory and clinical practice.