Kephera Diagnostics | CLIA-Certified Lab Testing for Infectious Disease

EndomTest™ is an innovative assay

The EndomTest™ for endometriosis combines an immunoassay on a patient’s blood sample with clinical information in a diagnostic algorithm.

The immunoassay measures the levels of two biomarkers in human serum: Brain Derived Neurotrophic Factor (BDNF) and Cancer Antigen 125 (CA125). Both BDNF and CA125 have been shown in studies to be elevated in the serum of patients with endometriosis versus healthy controls.

While each individual biomarker is not 100% specific to endometriosis, the combined measurements of the levels of both biomarkers together with selected patient history information was found to yield a highly specific assay for endometriosis, suitable as a “rule in” test.^1,2

Making testing more accessible

With the EndomTest™, clinicians now have a non-invasive blood test for endometriosis that offers an attractive alternative to laparoscopy—an invasive procedure with risks common to surgeries, including the potential for post-surgical complications. The specificity of the test means that a positive result provides a patient with certainty about their condition. The EndomTest™ offered by Kephera lowers the barriers to testing and makes early, accurate diagnosis more widely accessible.

Responsive service delivery

Working with Kephera Diagnostics is easy and convenient for clinicians. Upon receipt of the test order and sample, results are available in less than 14 days.

To inquire about the EndomTest™ please contact us

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This test is not FDA cleared. All tests were validated by Kephera Diagnostics. Test performance was determined to be pursuant to the requirements of CLIA ’88 for clinical testing.

FAQs

What is EndomTest™?

EndomTest™ is the first blood test designed to rule-in endometriosis for patients reporting symptoms associated with endometriosis. This test combines two blood biomarkers with a short clinical history to generate a positive or negative result based on a proprietary algorithm.

Who should be tested?

EndomTest™ is used to aid in a diagnosing endometriosis in women with symptoms associated with endometriosis. Common symptoms that may warrant EndomTest™ include painful menstrual cramps, chronic pelvic pain, heavy menstrual bleeding, infertility, pain with sexual activity, and pain with urination or defecation.

What does a negative result mean?

A negative result does not definitively rule out endometriosis. The negative predictive value will be based on the original indication for testing and the disease prevalence in that specific group. For example, if the reason for taking the test was chronic pelvic pain, the patient has around 65% probability of not having endometriosis. If the reason for taking the test is infertility, the patient has around 85.5% probability of not having endometriosis.

What does positive result mean?

EndomTest™ is designed to work as a rule-in test and has a positive predictive value of approximately 100%. A positive test result indicates that the patient has a very high probability of having endometriosis. Rare false positives were reported in one patient with ovarian cysts and one patient with fibroids.

What other tests are available for endometriosis diagnostics?

Currently, the gold standard for endometriosis diagnosis is a surgical diagnosis almost always performed via laparoscopy. In some cases, endometriosis can be diagnosed via ultrasound if certain types of endometriosis are present. Clinical studies are ongoing to improve diagnosis via both biomarkers and imaging.

Can someone who is taking hormonal birth control or endometriosis medications use EndomTest™?

Yes! EndomTest™ has been evaluated in individuals using endometriosis medications, hormonal contraceptives, and ovulation induction medications. However, the negative and positive predictive values of the test may be impacted depending on the specific information. For more information please contact us.

What is the detection rate for EndomTest™?

EndomTest™ will generally identify approximately half of patients with endometriosis. These patients will benefit from the certainty of their medical diagnosis without needing to experience the pain, risks, and downtime associated with surgery.

Who should not use EndomTest™?

EndomTest™ should not be used for asymptomatic endometriosis screening, during pregnancy, or to monitor response to endometriosis therapy.

What risks are associated with EndomTest™?

Risks of EndomTest™ are similar to other tests requiring blood work. Patients may experience discomfort at the time of blood collection, bruising, feeling faint/dizzy, and very rarely infection or nerve damage. Additionally, patients may experience emotional distress associated with receiving an endometriosis diagnosis.

References

Herranz-Blanco B. et al., Biomolecules 2023: 13, 1052
Daoud E. et al., Int’l J. Mol. Sci. 2024: 25, 7667

A new test for endometriosis: EndomTest™