Rapid Lateral Flow Immunoassay for Total Prostate-Specific Antigen (PSA)

Investigational device in the United States. OncoFirm™ PSA 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™ PSA is a single-use lateral flow immunoassay under development by OncoFirm Diagnostics for the detection of total prostate-specific antigen (PSA) in human [serum, plasma, and whole blood]. PSA is a protein produced by prostate tissue. Serum PSA, used together with digital rectal examination (DRE) and clinical judgment, is the most widely used laboratory aid in the detection of prostate cancer in men aged 50 and older. Elevated PSA is not specific for cancer and is also seen with benign prostatic enlargement, prostatitis, and other non-cancerous conditions.

The assay is designed to indicate whether total PSA is at or above a predefined cutoff in approximately 15 minutes, using a small volume of specimen and minimal equipment. The goal is to make an initial PSA result available in settings where laboratory testing is delayed or hard to reach, so that men with an elevated result can be directed promptly to quantitative laboratory testing and clinical evaluation. 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™ PSA is being developed as an in vitro diagnostic test for the [qualitative | semi-quantitative] detection of total prostate-specific antigen (PSA) in human [serum, plasma, and venous or fingerstick whole blood] at or above a cutoff of [4.0 ng/mL — under evaluation]. It is intended for use in conjunction with digital rectal examination as an aid in the detection of prostate cancer in men aged 50 years and older, when a clinician and patient have decided together that PSA testing is appropriate.

A result at or above the cutoff is not a diagnosis. It identifies men who should have quantitative laboratory PSA measurement and clinical evaluation. Prostate biopsy is required for the diagnosis of prostate cancer. 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™ PSA is not intended for monitoring patients with diagnosed prostate cancer, for active surveillance, for detecting recurrence after treatment, for use in men under [50] years of age, or for self-testing.

Product Design

Design specifications. Performance has not been established.

• Analyte: Total prostate-specific antigen (PSA)
• Specimen types: [Serum, plasma, venous whole blood, fingerstick capillary whole blood — each 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 the cutoff | Fluorescent signal read with the OncoFirm™ reader (in development)]
• Cutoff: [4.0 ng/mL design cutoff — under evaluation]
• Calibration: [Traceable to WHO reference material 96/670 | Hybritech-equivalent — to be specified; PSA cutoffs differ by calibration]
• Storage and shelf life: [To be established in stability studies]

About the PSA Biomarker

• PSA is produced by prostate tissue, and small amounts normally circulate in the blood. Serum PSA, used together with DRE, has been the principal laboratory aid in prostate cancer detection for more than three decades and is also used to help manage patients after a prostate cancer diagnosis.
• PSA is organ-specific, not cancer-specific. Levels rise with benign prostatic hyperplasia, prostatitis, urinary tract infection, recent ejaculation, and recent prostate procedures such as biopsy, cystoscopy, or catheterization. Medications such as finasteride and dutasteride lower PSA by roughly half, which clinicians take into account when interpreting results.
• No single cutoff separates cancer from benign disease. Prostate cancer can be present at PSA levels below 4.0 ng/mL, and most men with PSA between 4.0 and 10.0 ng/mL do not have cancer on biopsy. Clinicians commonly use age, PSA history, DRE findings, MRI, and additional biomarkers to decide whether biopsy is warranted.
• Major guidelines (USPSTF, AUA, ACS, EAU/ESMO) recommend that PSA testing for cancer detection be offered through an individualized, informed discussion of benefits and harms that considers age, race and ethnicity, family history, and life expectancy, rather than through routine or population-wide screening. The USPSTF recommends against PSA-based screening in men 70 and older.
• Values from different PSA assays are not interchangeable, and results calibrated to the WHO standard run roughly 20% lower than Hybritech-calibrated results. Serial monitoring of a patient should always use the same method.

Limitations

• Performance characteristics of OncoFirm™ PSA, including sensitivity, specificity, precision near the cutoff, and interference, have not been established.
• A result at or above the cutoff must be confirmed by a quantitative laboratory PSA assay and interpreted by a clinician together with DRE findings, history, and other clinical information. The test does not diagnose prostate cancer; biopsy is required for diagnosis.
• A result below the cutoff does not exclude prostate cancer.
• The test is not intended for monitoring patients with diagnosed prostate cancer, for active surveillance, or for detecting recurrence after treatment. Those uses require precise quantitative measurement at low concentrations (biochemical recurrence after prostatectomy is defined at 0.2 ng/mL), which a cutoff-based test does not provide.
• Benign prostatic conditions, recent ejaculation, prostate procedures, and 5-alpha-reductase inhibitors can affect PSA and therefore the result.
• 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™ PSA [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™ PSA 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™ PSA 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.]