Introducing Epoch Nova Dx
Epoch Nova Dx is a new test designed to aid healthcare providers in assessing lung cancer in high-risk patients as an adjunct to standard-of-care evaluation.
Introducing Epoch Nova Dx
Epoch Nova Dx is a new test designed to aid healthcare providers in assessing lung cancer in high-risk patients as an adjunct to standard-of-care evaluation.
EPOCH NOVA DX
Epoch Nova Dx is a simple, minimally invasive blood test that analyzes signals that may be associated with lung cancer in high-risk patients.*
Request Test Accessfor healthcare providers only
Important Notice for Ordering Providers: Nova Dx is a CLIA-regulated laboratory developed test. It is not FDA-cleared or
FDA-approved. Performance characteristics have been determined by Epoch Nova Dx. This test has not been reviewed by the U.S. Food and Drug
Administration. Results are one component of a broader diagnostic workup and should not be used as the sole basis for treatment decisions
A complementary workflow used alongside standard-of-care imaging and biopsy.
Epoch Nova Dx is easily integrated into existing clinical workflows — minimizing disruption while accelerating access to actionable insights for better patient care.
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Performance data reflect internal analytical validation against confirmed pathological diagnoses. All results should be interpreted alongsideclinical history, imaging findings, and provider judgment.
Measures overall discriminative ability across all thresholds. Values range from 0.5 (random) to 1.0 (perfect). An AUC of 0.904 indicates excellent separation of cancer from non-cancer cases.
Of all patients with confirmed lung cancer, Epoch Nova Dx correctly identifies ~95 out of every 100. High sensitivity minimizes missed diagnoses in high-risk populations.
When the test returns a low-risk result, there is >99% confidence cancer is absent. A high NPV makes Epoch Nova Dx a powerful rule-out tool for clinical decision support.
Epoch Nova Dx is designed to work alongside imaging — not
instead of it — offering an independent biological signal that can:
Provide additional confidence when LDCT findings are indeterminate
Support risk stratification in borderline cases
Aid in ruling out malignancy with a high-NPV result
Expand the diagnostic picture for patients not LDCT-eligible
*Results do not replace imaging, biopsy, or the clinical judgment of the treating provider.
Test developed and performed in a CLIA-certified facility (42 CFR Part 493).
An LDT is designed, validated, and run within a single lab. Following the 2025 court ruling vacating FDA's LDT Final Rule, LDTs remain governed primarily by CLIA.
Accuracy, precision, linearity, and interference studies consistent with CAP/CLSI guidelines.
EPOCH NOVA DX:
Information for Healthcare Professionals
EPOCH NOVA DX:
Epoch Nova Dx is laboratory test developed to aid clinicians in the earlier identification of lung cancer signals in high‑risk patients, as an adjunct to standard-of-care evaluation. It is designed to detect signals that may be associated with early-stage disease, with performance characterized in ongoing analytical and clinical validation studies.
REImBURSEMENT FOR Epoch Nova Dx
Epoch Nova Dx is a laboratory-developed test and reimbursement outcomes for this test may vary by payer and individual circumstances.
Epoch Nova Dx: ELIGIBILITY
Eligible individuals are 50-80 years old who have a 20+ pack-year smoking history, are currently smoking, or have quit smoking within the past 15 years.*
Clinical teams and providers, contact
Epoch Epigenetics Customer Services for your questions
about Epoch Nova Dx or for help ordering the test.
Indications for Use
Epoch Nova Dx is indicated as an adjunct assessment tool for individuals deemed as high risk by the USPSTF and eligible for lung cancer screening (50-80 years of age, 20 pack-years of smoking, currently smoking or has quit within 15 years).
Laboratory Information
Epoch Nova Dx is a laboratory-developed test. This test was developed, and its performance characteristics were determined by Epoch Epigenetics, Inc. It has not been cleared or approved by the US Food and Drug Administration (FDA). The laboratory is regulated under the Clinical Laboratory Improvement Act (CLIA) as qualified to perform high-complexity clinical tests. The test is used for clinical purposes. It should not be regarded as investigational or for research.
*The United States Preventive Services Task Force (USPSTF) recommends annual low-dose CT screening for lung cancer in adults aged 50-80 years who have a ≥20 pack-year smoking history, who currently smoke, or who have quit within the past 15 years.
