OncoFirm™ CEA

Rapid Lateral Flow Immunoassay for Carcinoembryonic Antigen (CEA)

Investigational device in the United States. OncoFirm™ CEA has not been cleared or approved by the U.S. Food and Drug Administration and is not available for sale in the United States. For Investigational Use Only. The performance characteristics of this product have not been established.

Overview

OncoFirm™ CEA is a single-use lateral flow immunoassay under development by OncoFirm Diagnostics for the detection of carcinoembryonic antigen (CEA) in human [serum, plasma, and whole blood]. CEA is a well-characterized tumor-associated antigen that is routinely measured in oncology practice as an aid in the management of patients with a diagnosed CEA-expressing cancer, most commonly colorectal cancer, where serial measurements help clinicians monitor response to therapy and watch for recurrence.

The assay is designed to provide a result in approximately 15 minutes from a small specimen volume with minimal equipment, with the goal of making CEA measurement more accessible in decentralized care settings. Whether and where the test may ultimately be used will depend on the results of validation studies and on the authorizations granted by regulatory authorities in each market.

Proposed Intended Use

Draft. Subject to change based on validation data and regulatory review.

OncoFirm™ CEA is being developed as an in vitro diagnostic test for the [qualitative | semi-quantitative] detection of carcinoembryonic antigen (CEA) in human [serum, plasma, and venous whole blood]. It is intended for use as an aid in the management of patients with a previously diagnosed CEA-expressing cancer, including monitoring of response to therapy and detection of recurrent or residual disease, in conjunction with clinical findings and other diagnostic procedures. The test is intended for professional use by trained healthcare personnel. [Use settings, including any near-patient use, will be defined by the regulatory authorization granted in each market.]

OncoFirm™ CEA is not intended for cancer screening in asymptomatic individuals and is not intended to be used alone to diagnose or rule out cancer.

Product Design

Design specifications. Performance has not been established.

• Analyte: Carcinoembryonic antigen (CEA)
• Specimen types: [Serum, plasma, whole blood — to be confirmed in analytical validation]
• Format: Single-use lateral flow immunoassay cassette
• Time to result: Approximately 15 minutes (design target)
• Readout: [Visual qualitative result relative to a predefined cutoff | Fluorescent signal read with the OncoFirm™ reader (in development)]
• Cutoff: [Under evaluation]
• Storage and shelf life: [To be established in stability studies]

About the CEA Biomarker

• CEA is one of the most widely used tumor markers in oncology. Current oncology practice guidelines support its use for postoperative surveillance and monitoring of patients with colorectal cancer.
• CEA may also be elevated in some patients with other malignancies, including cancers of the breast, lung, pancreas, and stomach; its clinical role in these settings is more limited.
• CEA is not specific for cancer. Levels can be elevated in smokers and in benign conditions such as inflammatory bowel disease, pancreatitis, liver disease, and chronic lung disease.
• Not all tumors produce CEA, and many early-stage cancers do not raise CEA above the reference range. Major clinical guidelines do not recommend CEA as a screening test for cancer in the general population.

Limitations

• Performance characteristics of OncoFirm™ CEA, including sensitivity, specificity, precision, and interference, have not been established.
• A CEA result must never be used on its own to diagnose or exclude cancer. Results should be interpreted by a qualified clinician together with the patient’s history, clinical findings, imaging, and histopathology.
• A result below the cutoff does not exclude the presence of cancer; a result at or above the cutoff does not confirm it.
• Values obtained with different CEA assay methods are not interchangeable. Serial monitoring of a patient should be performed with the same method.
• Not for self-testing or home use.

Development Program

Optional. Include only what is factually current.

OncoFirm Diagnostics is conducting [analytical] [and clinical] studies to characterize the performance of OncoFirm™ CEA [in collaboration with (institutions)]. 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

• European Union and other markets: OncoFirm™ CEA is CE marked [under the In Vitro Diagnostic Medical Devices Directive 98/79/EC | under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, certificate no. ____] and is available in [list countries] through authorized distributors. Availability and labeling vary by country; contact OncoFirm for local regulatory status.
• United States: OncoFirm™ CEA 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 pursue | is preparing] a premarket submission to FDA. The timing and outcome of any regulatory review cannot be assured.
• Product images on this page are concept renderings, illustrative of intended functionality.

Contact

[Contact details for healthcare professionals, laboratories, distributors, and research institutions. Note: inquiries from the United States are limited to research and investigational use.]