VolitionRx Ltd (NYSE American: VNRX) is a diagnostic testing company that develops blood-based tests using nucleosome and nucleosome-associated biomarker detection to identify cancer and other diseases in humans and companion animals. The company has not generated significant product revenue as of the 10-K filed 2026-03-31 and is in the commercialization stage for its Nu.Q product pipeline. VolitionRx operates through subsidiaries including Belgian Volition, which holds a manufacturing facility in Namur, Belgium certified to ISO 13485 since 2015, and Volition America, with offices in Carlsbad, California and Henderson, Nevada. The company competes against diagnostics companies with greater financial resources, established distribution networks, and broader product lines. Auditors have issued a going-concern opinion, and the company has disclosed material weaknesses in internal controls over financial reporting, as noted in the FY2025 10-K.
- Revenue model
- Pre-commercial stage; revenue model is not materially established as of the filing date (2026-03-31). Intended revenue would come from sales of diagnostic test kits and related products to laboratories, veterinary clinics, and healthcare providers, as well as potential third-party payor reimbursements.
- Products and services
- Nu.Q Vet Cancer Test: commercially available blood-based cancer screening test for dogs and other companion animals. Nu.Q NETs: blood test detecting diseases associated with NETosis, including sepsis. Nu.Q Discover: research-use platform for nucleosome profiling. Capture-PCR / Capture-Seq: patented liquid biopsy technologies for physical isolation of tumor-derived circulating tumor DNA fragments. ELISA kits manufactured at the Silver One facility in Namur, Belgium and via a third-party U.S. manufacturer.
- Customers and end markets
- End markets include human oncology diagnostics, veterinary diagnostics (dogs and companion animals), and infectious disease detection. Customer types include clinical laboratories, veterinary practices, research institutions, and third-party payors. No specific customer concentration data disclosed in the filing excerpts.
- Value-chain role
- Biomarker test developer and kit manufacturer. Belgian Volition manufactures antibodies, positive controls, and ELISA kits at the Silver One facility in Namur, Belgium. A portion of ELISA kit production is outsourced to a third-party U.S. manufacturer. The company holds patents on its core nucleosome detection and Capture-PCR / Capture-Seq technologies and works with Notified Body TUV SUD for EU IVDR conformity assessments.
- Geographic exposure
- Operations in Belgium (R&D laboratory and manufacturing in Namur), United Kingdom (London office at 93-95 Gloucester Place, lease commencing February 1, 2026), and United States (Carlsbad, California and Henderson, Nevada). Belgian Volition property in Namur purchased October 2016 (laboratory, EUR 1.2 million) and December 2020 (manufacturing, EUR 0.6 million).
Source: SEC 10-K, filed 2026-03-31
Industry:
In Vitro & In Vivo Diagnostic Substances
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