Investigational Multiplex Lateral Flow Assay for Cancer-Associated Biomarkers

Investigational device. OncoFirm™ MultiDx is in development and has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority. It is not available for sale. For Investigational Use Only. The performance characteristics of this product have not been established. No clinical claims are made for this product.

Overview

OncoFirm™ MultiDx is a multiplex lateral flow immunoassay under development by OncoFirm Diagnostics. The format is designed to measure more than one cancer-associated biomarker from a single [serum, plasma, or whole blood] specimen on one test strip, with each biomarker read in its own detection zone. The biomarkers under evaluation for the panel are [list each analyte — e.g., Thomsen–Friedenreich (TF) glycoantigen, CEA, PSA, AFP; confirm].

Multi-cancer detection is an active area of research worldwide. OncoFirm Diagnostics’ long-term research interest is whether rapid, low-cost multi-analyte testing could contribute to that field. No such use has been established for this product. OncoFirm™ MultiDx is not offered or represented as a screening test, and nothing on this page should be read as a claim that it detects any cancer.

Development Stage and Research Objective

This section replaces an intended-use statement. An intended use will be proposed only when validation data support one.

• Analytical objective: To establish that the multiplex format measures each panel analyte simultaneously in [specimen type(s)] with acceptable sensitivity, specificity, precision, and freedom from cross-reactivity and interference between zones, at defined cutoffs.
• Clinical research question: To evaluate, in [a defined study population], whether any individual analyte or combination of analytes measured by this assay is associated with the presence of cancer, and whether any such association could be clinically useful alongside existing methods of evaluation.
• What the assay is not being developed to do: OncoFirm™ MultiDx is not being developed as a substitute for any guideline-recommended cancer screening test (for example colorectal, breast, cervical, lung, or prostate screening), and is not intended to identify the organ of origin of a cancer.

Product Design

Design specifications. Performance has not been established.

• Analytes: [List each analyte and its detection zone]
• Specimen types: [Serum, plasma, whole blood — each to be confirmed in analytical validation]
• Format: Single-use multiplex lateral flow immunoassay cassette
• Detection chemistry: [Gold nanoparticle colorimetric | Fluorescent — state the one being validated]
• Time to result: Approximately 15 minutes (design target)
• Readout: [Visual qualitative result per zone | Signal read with the OncoFirm™ reader (in development)]
• Cutoffs: [Under evaluation, per analyte]
• Digital components: [Reader and companion software are in development and will be evaluated as part of the regulated test system]
• Storage and shelf life: [To be established in stability studies]

About Multi-Cancer Detection and the Panel Biomarkers

• Multi-cancer detection tests. The MCD tests available today are laboratory-developed tests run in central laboratories, based on genomic sequencing of cell-free DNA. FDA treats MCD tests as Class III devices. As of this writing, no MCD test has received FDA approval; the first premarket approval application for an MCD test was submitted in January 2026 and is scheduled for FDA advisory committee review in September 2026, supported by a prospective U.S. study of about 25,000 participants and a randomized trial of more than 140,000 adults. Even the developers of that test describe it as an addition to, not a replacement for, guideline-recommended screening.
• Why the evidence bar is high. In a screening population most people do not have cancer, so even a small false-positive rate produces many false alarms, each leading to imaging, procedures, and anxiety, while false negatives can cause people to skip proven screening. Regulators therefore expect prospective performance data in asymptomatic populations, positive predictive value at real-world prevalence, and, for tests that claim to identify cancer type, accuracy of that prediction.
• Panel biomarkers. [For each analyte, one or two factual sentences on its established role and limitations. For TF antigen: a carbohydrate structure exposed on many carcinomas, studied for decades in tissue; blood measurement is at an early research stage; not specific to any organ. For CEA, PSA, and AFP: established tumor markers whose authorized uses are in the management or, for PSA, detection-with-DRE of specific cancers; none is authorized for multi-cancer screening.]
• Established screening. Guideline-recommended screening exists for colorectal cancer (stool-based tests or colonoscopy), breast cancer (mammography), cervical cancer (cytology and HPV testing), lung cancer in people with a significant smoking history (low-dose CT), and prostate cancer (PSA testing after an informed discussion). No blood test is a substitute for any of these. For ovarian cancer, the FDA has recommended against the use of any test marketed for screening; for pancreatic cancer, the USPSTF recommends against screening in asymptomatic adults.

Limitations

• Performance characteristics of OncoFirm™ MultiDx, including per-analyte sensitivity, specificity, precision, cross-reactivity, and interference, have not been established. No clinical performance claims are made.
• OncoFirm™ MultiDx is not a cancer screening test and is not intended for use in the general population, in primary care screening, or in population, employer, or government screening programs.
• OncoFirm™ MultiDx is not a substitute for any guideline-recommended screening test and is not intended to defer, replace, or reduce their use.
• The assay does not identify the type or organ of origin of any cancer. A signal in a given zone indicates the presence of that analyte, not a specific cancer.
• The assay is not intended for individuals at high hereditary risk, as a diagnostic aid, for treatment planning, or for monitoring after a cancer diagnosis. None of these uses has been studied.
• A result below a cutoff does not exclude cancer; a result above a cutoff does not establish it.
• Not for self-testing or home use.

Development Program

Include only what is factually current. If a clinical study is ongoing, be prepared to identify its registration.

OncoFirm Diagnostics is conducting [analytical] [and clinical feasibility] studies of the multiplex format [in collaboration with (institutions)] [registered as (registry and identifier)]. Findings will be [published | submitted to regulatory authorities] as they become available. Healthcare professionals and institutions interested in research collaboration may contact [email].

Regulatory Status

• United States: OncoFirm™ MultiDx has not been cleared or approved by the U.S. FDA and is not available for sale in the United States. Any U.S. use is limited to investigational use. OncoFirm Diagnostics [intends to seek FDA feedback on a development plan through the Pre-Submission program | is preparing a premarket submission]. The timing and outcome of any regulatory interaction cannot be assured.
• European Union and other markets: OncoFirm™ MultiDx is not CE marked and is not authorized for sale in any market. [If and when that changes, replace with: “CE marked under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, Class C, notified body certificate no. ____, available in (countries).” Do not state a planned launch date or a planned CE mark.]
• Product images on this page are concept renderings, illustrative of intended functionality.

Contact

[Contact details for research institutions, laboratories, and potential clinical collaborators. Note: inquiries are limited to research and investigational use.]