Gynecologic Cancer Test

One Sample. Earlier Answers. Broader Coverage.

The EpiLume Gynecologic Cancer Test is a next-generation DNA methylation assay designed to advance women’s cancer detection beyond conventional one-disease-at-a-time screening. Built on GPS marker-discovery engine and bisulfite-free Me-qPCR platform, it is designed to detect cervical cancer, cervical adenocarcinoma including gastric-type adenocarcinoma, and endometrial cancer from a single cervical sample—with the potential to identify disease risk as early as the precancerous stage.

A More Advanced Approach to Gynecologic Cancer Detection

Current screening pathways have improved outcomes, but important clinical gaps remain.

HPV testing is highly useful, yet HPV positivity is not equivalent to cancer, often creating excess follow-up, unnecessary anxiety, and referral burden. Cytology remains an important tool, but it is inherently dependent on specimen quality, interpretation, and access to experienced pathology resources. These limitations are especially relevant for glandular disease, including cervical adenocarcinoma, where missed detection remains a real concern. Endometrial cancer adds another challenge: there is still no widely adopted, accurate, minimally invasive screening solution for routine early assessment.

The EpiLume Gynecologic Cancer Test was developed to address these unmet needs with a platform that is molecularly objective, operationally streamlined, and clinically actionable.

What This Test Covers

From one cervical collection, the assay is designed to support risk assessment for:

• Cervical squamous cell carcinoma

• Cervical adenocarcinoma

• Gastric-type cervical adenocarcinoma

• Endometrial cancer

• High-grade precancerous lesions associated with these diseases

This broader clinical scope helps address a major weakness of conventional workflows: fragmented testing across multiple gynecologic cancers.

Why EpiLume Stands Out

Multi-cancer insight from a single sample

Rather than screening one condition at a time, EpiLume is positioned as a single-sample molecular solution for multiple clinically important gynecologic cancers. That means a more efficient workflow for laboratories and a more comprehensive answer for clinicians and patients.

Earlier signal biology

DNA methylation changes arise early in carcinogenesis and can remain informative across the disease continuum, from early risk detection to treatment monitoring and recurrence assessment.

Bisulfite-free methylation detection

The assay is built on Me-qPCR platform, a fully automated, bisulfite-free methylation workflow designed to reduce complexity, preserve DNA integrity, and improve reproducibility compared with conventional bisulfite-based workflows.

Quantitative, not just qualitative

Our methylation platform incorporates a proprietary quantitative analysis framework and dynamic monitoring model, enabling a more nuanced interpretation of disease risk rather than a simple yes/no result.

Designed for real clinical bottlenecks

The test is particularly relevant where existing screening pathways struggle:

• hrHPV-positive triage

• ASC-US and LSIL triage

• suspected glandular lesions

• double-negative but symptomatic patients

• post-treatment surveillance

Clinical Evidence

Strong discrimination for clinically meaningful cervical disease

In published data, PCDHGB7 methylation showed clear separation between CIN2+ and CIN1− groups, with an ROC AUC of 0.91 (95% CI, 0.86–0.95), outperforming cytology in this setting.

Better triage performance in hrHPV-positive women

In a cohort of 3,251 high-risk HPV-positive women, methylation-based triage reduced both over-referral and missed diagnosis compared with cytology-based triage:

• HPV + cytology triage: over-referral 20.58%, missed diagnosis 6.50%

• HPV + methylation triage: over-referral 9.26%, missed diagnosis 3.24%

This is a meaningful advantage for healthcare systems seeking to improve colposcopy efficiency without sacrificing clinical sensitivity.

Improved support for adenocarcinoma detection

Among confirmed cervical cancer cases in hrHPV-positive women, methylation testing showed stronger sensitivity than cytology, particularly for adenocarcinoma, a subtype that remains more difficult to detect using conventional screening alone. Company materials report missed detection rates of 0% vs. 21.9% for SCC and 0% vs. 40% for adenocarcinoma in the compared setting.

Potential value in gastric-type adenocarcinoma

This matters because gastric-type cervical adenocarcinoma is one of the most challenging cervical malignancies in routine practice. We report performance in this subgroup of 83.33% sensitivity, 86.96% specificity, 62.50% PPV, 95.24% NPV, and 86.21% accuracy.

Endometrial cancer detection from minimally invasive sampling

The platform also addresses a key unmet need in women’s health: earlier evaluation for endometrial cancer. In blinded studies, performance was reported as:

• Pap brush samples: sensitivity 80.65%, specificity 82.81%

• Tao brush samples: sensitivity 61.29%, specificity 95.31%

That creates an opportunity to expand beyond cervical-only workflows toward broader gynecologic cancer assessment.

Platform Strength Behind the Product

The product story is stronger because the platform story is stronger.

• 100+ collaborating hospitals

• 200,000+ double-blind validated clinical samples

• 18 PCT applications

• 17 invention patents

• 11 international authorizations

• 42 accepted patent filings

Its discovery engine is based on Guide Positioning Sequencing (GPS), which is a high-coverage methylome platform with 96% coverage, supporting broad marker discovery and full-lifecycle cancer monitoring.

This is not a one-off assay. It is a scalable epigenomics platform with translational depth.

Operational Advantages for Labs and Health Systems

The Me-qPCR workflow is positioned for real-world implementation:

• Bisulfite-free

• High reproducibility

• Lower workflow burden

• Faster turnaround

• Quantitative readout for follow-up

The platform processed up to 282 samples per day on a single qPCR instrument with a single operator, compared with materially lower throughput for conventional bisulfite-based workflows.

That makes the test particularly attractive for:

• reference laboratories

• hospital molecular labs

• women’s health screening programs

• decentralized clinical settings seeking advanced oncology diagnostics without NGS-style workflow burden

Intended Use Scenarios

The EpiLume Gynecologic Cancer Test is designed to support several clinically relevant scenarios:

1. Screening

For women seeking a more advanced molecular screening option, especially when broader gynecologic cancer coverage is desired.

2. Triage in hrHPV-positive patients

To improve referral efficiency and reduce unnecessary colposcopy burden.

3. Adjunctive evaluation in equivocal or high-risk cases

Including:

• ASC-US • LSIL • persistent symptoms despite negative routine testing • suspicion of gastric-type cervical adenocarcinoma

4. Post-treatment monitoring

The quantitative methylation framework supports longitudinal assessment after treatment and during surveillance.

A Stronger Vision for Women’s Cancer Detection

The future of gynecologic oncology diagnostics will not be built on fragmented, single-endpoint tests alone. It will be built on platforms that are:

• molecularly earlier

• clinically broader

• operationally scalable

• quantitative over time

• fit for real-world implementation

The EpiLume Gynecologic Cancer Test is positioned at that intersection—bringing together epigenomic discovery, multi-cancer insight, and clinical practicality in a single solution.

Bring a more advanced molecular strategy to gynecologic cancer detection. Contact us to discuss clinical adoption, laboratory partnerships, licensing, or regional commercialization opportunities.

Ordering Info:

DNA Methylation Detection Kits (qPCR) for PCDHGB7 are CE-marked products for In Vitro Diagnostic Use.

DNA Methylation Detection Kits (qPCR) for PCDHGB7 are not FDA-cleared.