Until now, diagnosis of endometriosis has been limited by the absence of a highly accurate Tier-1 diagnostic test. With millions of women going undiagnosed with this debilitating disease for close to a decade, it is exacerbated by the fact that nonspecific and non-targeted treatment is also limited, which often results in less than satisfactory outcomes.   

To a significant degree, this also limits medical providers, who subsequently face ongoing challenges in differentiating endometriosis symptoms from symptoms of conditions with similar presentations, causing diagnostic and treatment delays. 

However, with the introduction of the first and only Tier-1 diagnostic test for this disease, the world is on the verge of a quantum shift in the diagnosis and treatment for endometriosis. 

What Is a Tier-1 Diagnostic Test? 

A Tier-1 diagnostic test typically refers to a highly accurate, fundamental assessment, or procedure that enables clinicians to effectively screen, monitor, or identify the specific underlying cause of a patient’s symptoms. Tier-1 diagnostic tests help providers move closer to an appropriate treatment specifically targeted to address the underlying cause of symptoms. 

Three Tiers of Diagnostic Tests 

There are three tiers of diagnostic tests, with each tier varying in purpose, speed, precision, and cost. 

Tier-1 Diagnostic Tests 

Tier-1 diagnostic tests are typically the first investigational tests medical providers use to detect the presence of disease. Tests in this category are highly accurate, easy to use, widely available, broadly applicable to the population without limitation, and provide rapid results. They are generally non-invasive or minimally invasive as well as low cost. 

Anemia is one example of a condition where a physician may use a Tier-1 test, such as a complete blood count (CBC), to determine the underlying cause of a patient’s symptoms. A CBC measures a patient’s red blood cell count, hematocrit, and hemoglobin levels. If these markers are low, it may be enough for a physician to diagnose that the patient is anemic. 

Tier-2 Diagnostic Tests 

Tier-2 diagnostic tests are generally used as localizing tests. They are used to pinpoint where in the body the issue is occurring. Typically, Tier-2 tests are used either after a Tier-1 test is positive or warrants further exploration. 

Tests in this category are generally more complex and take more time to receive results, and cost more than Tier-1 tests. They can be highly effective when appropriately used. For example, to better diagnose anemia, a Tier-2 test such as a stool blood test helps the physician determine if there is a problem with blood loss from a particular place in the body. 

Tier-3 Diagnostic Tests 

Tier-3 diagnostic tests are also localizing tests. The advantage of this category of tests is that a physician can visualize as well as treat the source of the problem. Tier-3 tests are much more complex, expensive, with results slower than other categories of tests. They generally offer the ability to combine treatment with diagnosis. 

An example of a Tier-3 test in anemia is colonoscopy for identification of a bleeding colonic lesion like a polyp, with subsequent removal (polypectomy). 

This multi-tiered approach to diagnostic testing is the standard for most diseases. Medical providers generally begin with Tier-1 tests - the fastest, most accessible tests - to determine whether a patient has a disease, and progress to more specialized, complex tests to localize and treat as needed. 

However, for endometriosis, diagnostic laparoscopic surgery – a Tier-3 test with associated lower levels of accuracy, risks, and higher expense - has remained the diagnostic standard for a definitive diagnosis. This has changed.   

A Call for a New Diagnostic Framework for Endometriosis 

Prior to 2022, a Tier-1 diagnostic test did not exist to screen for endometriosis. This restricted medical providers to rely on Tier-2 imaging tests and diagnostic surgery (Tier-3) to localize endometrial lesions and begin therapy. A significant limitation of this approach has been that neither imaging studies nor laparoscopic surgery is suitable for diagnosing all subtypes of endometriosis. [1, 2, 3] 

Tier-2 Imaging Tests Limitations 

Transvaginal ultrasound (TVUS) and MRI are the two most common imaging tests used to clinically diagnose endometriosis. Though both are useful in detecting deep infiltrating endometriosis, they fall short in reliably detecting superficial endometriosis. [2]   

Tier-3 Diagnostic Laparoscopic Surgery Limitations 

Diagnostic laparoscopic surgery allows medical providers to visually confirm endometrial lesions and obtain histopathologic confirmation on biopsied tissue. Generally, histopathologic confirmation is considered definitively accurate. The limitation of laparoscopic surgery lies in the surgeon’s ability to identify the lesions. A surgeon may not be able to see and consequently remove suspicious lesions if they are hidden deep within or outside the pelvic cavity, which may result in a false negative for disease. [2, 3] 

Moreover, Tier-3 diagnostic laparoscopic surgery is invasive, expensive, and has associated risks. The number of women who are offered or opt to undergo this procedure is comparably small compared to the number of women who continue to suffer from the symptoms of endometriosis without a formal diagnosis. This disparity contributes to diagnostic delays and disease progression.   

Why a Tier-1 Diagnostic Test for Endometriosis Is Critically Important 

The need for a Tier-1 diagnostic test in endometriosis cannot be overstated.  Without an objective method to reliably detect the irrefutable presence of this complex disease, medical providers may be confined to work in the dark and suggest limited empiric non-targeted therapy. 

Furthermore, without access to tests that offer rapid results, women will continue suffering an average of 8.6 years [4] or more with chronic, often-debilitating symptoms and ineffective treatments before ever knowing what is wrong. Timely diagnosis and effective treatment of endometriosis are vital to a patient’s quality of life. 

As Dr. Larry Glazerman, a leading gynecologist, explains:   

“The ability to diagnose endometriosis without an invasive surgical procedure and avoid the typical 7- to 10-year delay in diagnosis can revolutionize the management of this debilitating condition for millions of women around the world.” 

With a reliable Tier-1 diagnostic test for endometriosis in place, medical providers can confidently screen and diagnose greater numbers of patients, facilitating warranted, faster and more targeted therapy intervention. 

The ENDOSURE TEST: A Tier-1 Diagnostic Test for Endometriosis 

As the very first Tier-1 diagnostic test for endometriosis, the ENDOSURE TEST is positioned to shift the entire paradigm in how medical providers detect and treat endometriosis. It is: 

• Low cost 
• Easy-to-use 
• Noninvasive 
• Rapid result (30 minutes) 
• Highly accurate 
• No population-related use restriction 
• Surgically verified 

It fills all the major requirements of a Tier-1 diagnostic test and directly addresses a significant gap in endometriosis diagnostics. 

More importantly, the ENDOSURE TEST equips medical providers with the means to overcome many of the limitations associated with using imaging studies and laparoscopic surgery alone to detect endometriosis. As a non-invasive, highly accurate, 30-minute test, capable of reliably detecting endometriosis at any age and anywhere in the anatomy, the ENDOSURE TEST enhances the utility of Tier-2 and Tier-3 tests because physicians will know that the disease is already present. 

The TEST also empowers medical providers to better manage the disease by giving them insight into which patients will likely respond to treatment. Dr. David Griffiths, a leading gynecologist in the United Kingdom, explains: 

“The ENDOSURE TEST has proved an invaluable tool for my practice. It has been particularly beneficial for my adolescent patients. I can now offer a reliable and noninvasive test to confirm my clinical suspicions of endometriosis/adenomyosis without the need for surgery.” 

Conclusion 

Diagnostic delays in endometriosis have largely been due to the lack of Tier-1 diagnostic tests - low cost, highly accurate, and easily accessible tests that can quickly and reliably detect the presence of endometriosis. 

Since the introduction of the ENDOSURE TEST in 2022, this is no longer the case. Medical providers are now empowered to detect endometriosis at its earliest stages and offer targeted, personalized therapy to their patients. Patients, too, are empowered because they no longer must wait nearly a decade before ever knowing what is wrong, offering hope to every woman afflicted with this horrible disease.   

If you think you have endometriosis, talk to your healthcare provider. 

Learn more about the ENDOSURE TEST. 

References: 

1. Mettler L, Schollmeyer T, Lehmann-Willenbrock E, et al. Accuracy of laparoscopic diagnosis of endometriosis. JSLS. 2003;7(1):15-18.

2. Pascoal E, Wessels JM, Aas-Eng MK, et al. Strengths and limitations of diagnostic tools for endometriosis and relevance in diagnostic test accuracy research. Ultrasound Obstet Gynecol. 2022;60(3):309-327. doi:10.1002/uog.24892 

3. Simko S, Wright KN. The future of diagnostic laparoscopy - Cons. Reprod Fertil. 2022;3(2):R91-R95. Published 2022 Apr 20. doi:10.1530/RAF-22-0007 

4. Frankel LR. A 10-Year Journey to Diagnosis With Endometriosis: An Autobiographical Case Report. Cureus. 2022 Jan 17;14(1):e21329. doi: 10.7759/cureus.21329. PMID: 35186587; PMCID: PMC8849430.