Professional FAQ

The Basics

1. What is the OncoE6™ Cervical Test?

The OncoE6™ Cervical Test is an advanced diagnostic tool used in cervical cancer screening. It is a qualitative, proteomic-based test that detects the E6 oncoprotein, a specific biomarker produced by the highest-risk Human Papillomavirus (HPV) types, 16 and 18. Unlike standard HPV DNA tests that only confirm the presence of the virus, the OncoE6™ test identifies infections that are actively progressing towards cancer, making it a more precise indicator of true disease risk. [1]

2. How does the OncoE6™ test work?

The test works by identifying the E6 oncoprotein, which is a key driver of HPV-related cancer. The E6 protein disables one of the body's natural tumor suppressors (p53), allowing abnormal cells to grow uncontrollably. A positive OncoE6™ test means that an HPV infection is not only present but is actively producing the proteins that cause cellular transformation—a critical step in the development of cancer. [2, 3] This direct detection of oncogenic activity is why the test is sometimes referred to as a “molecular colposcopy,” as it provides a biochemical confirmation of the disease process that a physical colposcopy seeks to find visually.

3. What is the intended role of the OncoE6™ test in screening?

The OncoE6™ test is designed to be used as a triage test. It is not a primary screening tool. Its role is to further evaluate women who have already tested positive for high-risk HPV. By accurately identifying which of these HPV-positive women have infections that are actively progressing, it helps determine who truly needs an immediate referral for a colposcopy and potential biopsy, while sparing low-risk women from unnecessary procedures. [2, 4, 5, 6]

Understanding Test Performance

4. What does the test's high "specificity" mean in practical terms?

Specificity is a measure of a test's ability to correctly identify people who do not have a disease. The OncoE6™ test has an exceptionally high specificity, often reported between 97% and 99%.

To put this into perspective:

  • A test with 99% specificity will produce only 1 false positive for every 100 healthy individuals tested.
  • In contrast, a test with 90% specificity will produce 10 false positives for every 100 healthy individuals—a tenfold increase in false alarms that lead to unnecessary anxiety and procedures.
This high specificity is what allows the OncoE6™ pathway to dramatically reduce the number of unnecessary colposcopies.

5. What does the test's high "Positive Predictive Value (PPV)" mean?

Positive Predictive Value (PPV) tells you the probability that a person with a positive test result actually has the disease. It answers the patient's most important question: "If my test is positive, what are the chances I'm actually sick?"

The difference is significant:

  • The OncoE6™ test has been reported to have a PPV of over 40% for high-grade precancer (CIN3+). This means that roughly 1 in 2 women with a positive result will have a confirmed high-grade lesion. [7, 4]
  • Standard HPV DNA tests often have a PPV of less than 10%. This means only 1 in 10 women with a positive result truly has the disease, and the other nine are subjected to follow-up procedures for what was a false alarm. [7, 4]

Benefits for Specific Patient Groups

6. Why is the OncoE6™ test particularly valuable for women under 30?

Women under 30 have a very high rate of transient HPV infections (over 27%) that their bodies clear naturally. [8, 9, 10, 11, 12] The current standard of care often leads to these harmless infections being flagged for colposcopy and treatment with procedures like LEEP. This overtreatment carries a significant "biological cost," as LEEP is linked to an increased risk of future infertility, miscarriage, and preterm birth. [13, 14, 15, 16, 17, 18, 19, 20, 21, 22] Given the societal trend of delaying childbearing, this risk is a major concern. The OncoE6™ test avoids this by accurately identifying the very small number of young women whose infections are truly dangerous, thereby preventing the vast majority from undergoing unnecessary and potentially harmful procedures.

7. How does the OncoE6™ test help women over 65?

Women over 65 account for 20% of cervical cancer cases and a disproportionately high number of deaths, often due to late-stage diagnosis. [23, 24, 25, 26, 27, 28, 29] Standard tests perform poorly in this group due to postmenopausal changes (atrophy) that can cause both false-positive and false-negative results. [23, 26] The OncoE6™ test overcomes these issues:

  • Its high specificity minimizes false negatives caused by atrophy.
  • Its mechanism, which detects active oncoproteins, is highly sensitive for the advanced lesions and cancers more common in this age group.
This allows for earlier and more accurate detection, preventing the high human and financial costs of late-stage cancer.

Cost and Clinical Integration

8. Is the OncoE6™ Triage Pathway cost-saving?

Yes. The health economic model shows that the OncoE6™ pathway is a dominant economic strategy.

  • For all women, it saves money by significantly reducing the number of costly colposcopies and LEEP procedures.
  • For women under 30, the savings are immense, encompassing not only direct medical costs but also the averted societal costs of treating infertility and managing preterm births.
  • For women over 65, it is highly cost-effective by preventing the extremely high costs associated with treating late-stage cancer.
The model shows the molecular biopsy pathway achieves superior clinical outcomes with significant cost-savings.

9. How does the OncoE6™ test align with current ASCCP management guidelines?

The 2019 ASCCP guidelines are built on the principle of "equal management for equal risk," where clinical action is determined by a patient's calculated risk of having high-grade disease (CIN3+). [30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40] The key threshold for referring a patient to colposcopy is an immediate CIN3+ risk of 4% or greater. [32, 41] The OncoE6™ test fits perfectly into this framework by providing a highly accurate, biological measure of which HPV-positive women actually exceed this risk threshold, allowing for more precise and appropriate patient management.

References