Kephera Diagnostics | Infectious Disease Testing

How to Order a Test

Tests can only be ordered by a healthcare provider.

Download and fill out a Test Requisition Form and have it approved by a healthcare provider.
Collect sample according to Sample Handling Instructions
Send sample to Kephera Diagnostics laboratory according to Shipping Instructions
Receive Test Report – View a sample report
Turnaround time for all tests is ≤ 14 days

To inquire about the EndomTest please contact us at info@kephera.com

Kephera Diagnostics is a CLIA- and CAP-accredited laboratory operating since 2020.

CLIA ID number 22D2182419

CAP number 8879616

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.

Questions?

Read our General FAQs or Contact us

Order EndomTest™ for endometriosis

How to Order a Test

FAQs

Questions?