Ludwig Enterprises Inc (OTC: LUDG) is a pre-revenue oncology diagnostics company developing at-home, non-invasive cancer screening tests based on mRNA biomarker analysis from cheek-swab samples. The company has generated no product revenue as of its 10-K filed March 16, 2026, and relies entirely on debt financing to fund operations, having borrowed approximately $3,000,000 in loans to cover professional fees and day-to-day expenses through the filing date. Its lead product, the Revealia Breast test, uses a proprietary 48-gene inflammatory biomarker panel processed by ensemble machine-learning models to identify cancer-associated expression patterns. A second product, Revealia Ovarian, is in development. Preliminary validation on 249 breast cancer samples showed approximately 86% negative predictive value, but results have not been reviewed or approved by the FDA. The intended commercialization model is B2B2C, distributing through healthcare providers, employers, and insurer partnerships, with long-term revenue dependent on securing insurance reimbursement and CLIA and CAP laboratory certification.

Revenue model

No revenue has been generated as of the fiscal year ended December 31, 2025. The intended future revenue model is transactional, with tests ordered through B2B2C channels including healthcare providers and employer or insurer partnerships. Long-term commercial viability is contingent on securing reimbursement from commercial insurers and public payors following publication of peer-reviewed validation data.

Products and services

Revealia Breast: an at-home cheek-swab test analyzing a 48-gene inflammatory biomarker panel via next-generation sequencing and ensemble machine-learning models, with preliminary validation showing ~86% negative predictive value across 249 samples (as of the 10-K filed March 16, 2026). Revealia Ovarian: a second assay targeting mRNA expression patterns associated with ovarian cancer, currently in development. Both tests are intended to be fulfilled through at-home collection kits with laboratory analysis at CLIA-certified, CAP-accredited partner facilities.

Customers and end markets

Intended end markets are breast and ovarian cancer screening populations. Target ordering channels include healthcare providers, employers, and captive insurers under a B2B2C model. Payers, including commercial insurers and public payors, are identified as critical to long-term adoption. No paying customers existed as of the fiscal year ended December 31, 2025.

Value-chain role

Early-stage diagnostic test developer and platform provider. The company designs the biomarker panel, machine-learning algorithms, and sample collection kit, while outsourcing laboratory analysis to CLIA-certified, CAP-accredited partner labs. Kit fulfillment, sample return logistics, and results delivery are part of the intended operational infrastructure.

Competitors

CA-125 blood testing (clinical standard for ovarian cancer monitoring), Transvaginal ultrasound (clinical standard for ovarian screening), Mammography, Breast MRI, Cologuard (Exact Sciences, acquired by Abbott in a deal announced November 2025)

Source: SEC 10-K, filed 2026-03-16

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