Medical Disclaimer
suPARbio™ Systemic Chronic Inflammation Test
Effective Date: March 1st, 2026
Introduction
This Medical Disclaimer (“Disclaimer”) provides important information regarding the suPARbio™ Systemic Chronic Inflammation Test (the “Test”), a quantitative blood test that measures soluble urokinase plasminogen activator receptor (suPAR) in human plasma. The Test is offered as a Laboratory Developed Test (LDT) under CLIA regulations and has not been cleared or approved by the U.S. Food and Drug Administration (FDA).
By ordering, purchasing, distributing, or using this Test, you acknowledge and agree to the terms outlined in this disclaimer below.
1. Intended Use and Informational Purpose
The suPARbio™ Systemic Chronic Inflammation Test is a quantitative blood test that measures the concentration of soluble urokinase plasminogen activator receptor (suPAR) in human plasma (EDTA).
The Test is intended for general wellness purposes and may serve as an adjunctive tool to provide information about systemic chronic inflammation status in adults. It may also be used over time to monitor changes in suPAR levels, which may provide insight into associations with lifestyle factors such as diet, physical activity and stress. . This Test is not intended to diagnose, treat, cure, or prevent any disease or medical condition. Results are provided for informational purposes only and must be interpreted by a qualified healthcare provider in the context of the individual’s health history, symptoms, and other relevant findings.
2. Consultation with Healthcare Professionals
We encourage you to consult with a licensed healthcare provider or physician to discuss your Test results and their potential relevance to your health and wellness. Your healthcare provider is best equipped to interpret the results in the context of your overall health history and other clinical information.
The test is not intended to be used as a basis for making medical or treatment decisions without professional guidance. Do not disregard professional medical advice or delay seeking medical care based on the information provided by the Test. Always seek the advice of your healthcare provider with any questions regarding a medical condition or treatment.
3. FDA Status Disclosure
This test has been validated as a Laboratory Developed Test (LDT) under CLIA regulations. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA) and is not intended to diagnose, treat, cure, or prevent any disease or medical condition. Test results should be interpreted by a qualified healthcare provider in the context of the patient’s clinical history, symptoms, and other laboratory findings. At this time, this test is not available for residents of the State of New York. No representation is made that the Test has undergone FDA review or is FDA-cleared or approved.
4. Specimen Collection and Handling
This kit is intended for use by trained healthcare professionals (e.g., licensed phlebotomists). Although the kit may be delivered to a home or non-clinical setting, blood collection must only be performed by qualified personnel.
Do not attempt to collect blood from yourself; do not collect blood from others unless you are a trained and licensed healthcare professional. Blood collection may be associated with risks, including pain, bruising, bleeding, infection, dizziness, or fainting. Single-use components only. Do not use it if packaging is damaged or has been previously opened.
4. Interpretation Responsibility
suPAR is a non-specific biomarker linked to systemic chronic inflammation. Elevated suPAR levels have been reported in the scientific literature in connection with a variety of physiological and pathological contexts including inflammatory states and certain chronic conditions (e.g., cardiovascular and metabolic conditions). .
Due to suPAR’s non-specific nature, test results must be interpreted by a licensed healthcare provider in the context of the individual’s overall clinical presentation and other relevant information. suPAR Biomarker LLC does not provide medical advice, diagnosis, or treatment recommendations. Patients should consult their healthcare provider for interpretation of results and appropriate follow-up.
5. Limitation of Liability for Use and Results Interpretation
To the fullest extent permitted by applicable law, the use of the Test and reliance on its results are at your discretion and risk. suPAR Biomarker LLC, its affiliates, licensors, and suppliers shall not be liable for any indirect, incidental, consequential, or special damages arising from or related to the use of the Test, reliance on the results, or decisions made based on the information provided.
suPAR Biomarker LLC does not assume responsibility for interpretation or use of Test results outside the context of consultation with a qualified healthcare provider, including any incorrect interpretation, improper use, or actions taken based on the results.
Nothing in this Disclaimer excludes or limits liability where such exclusion is not permitted under applicable law.
6. Biological Age Index
Where reported, the suPARbio™ Biological Age Index is a calculated statistical indicator that compares estimated biological age with chronological age. The estimate is derived from population-level reference data and reflects the typical suPAR values observed in healthy individuals of the same sex and age within a defined reference population.
A Biological Age Index higher than chronological age may be observed in individuals whose suPAR levels differ from population averages; such differences have been described in the scientific literature in relation to systemic chronic inflammation.
The Biological Age Index is a statistical model and is not a measure of biological or physiological age,nor is it intended to assess health status, disease risk, or longevity. It is not a diagnostic tool and should not be used to make medical or treatment decisions... Reference ranges are derived primarily from Northern European populations and may not be universally applicable across all ethnic or demographic groups.
7. No Doctor–Patient Relationship
Use of the suPARbio™ Systemic Chronic Inflammation Test does not establish a doctor–patient relationship between any individual and suPAR Biomarker LLC, its affiliates, or its personnel, including employees, contractors, laboratory partners, or representatives. The Test results and any accompanying information are provided for informational purposes only and are not intended to create any clinical relationship or replace professional medical judgment. suPAR Biomarker LLC does not provide medical care, diagnosis, or treatment services.. All medical questions, concerns, and treatment decisions should be directed to a licensed healthcare provider.
8. No Liability in Laboratory Sample Processing
suPAR Biomarker LLC is not responsible for delays, errors, or issues arising from third-party activities related to sample collection, transport, handling or processing. By using the suPARbio™ Systemic Chronic Inflammation Test, you acknowledge and agree that suPAR Biomarker LLC and any affiliated or contracted laboratories shall not be responsible for any damages, losses, or adverse outcomes related to laboratory procedures, including but not limited to pre-analytical, analytical, or post-analytical processes conducted in accordance with applicable regulatory standards.
Additional Considerations
A. Accuracy and Limitations
While the suPARbio™ Systemic Chronic Inflammation Test has been validated and is grounded in established scientific methodologies, no laboratory test is without limitations. The accuracy and reliability of the Test may be influenced by multiple factors, including but not limited to sample quality, collection and handling procedures, laboratory processes,interfering substances (e.g. supplements, medications) and inherent biological variability. suPAR Biomarker LLC does not guarantee that Test results will be error-free or universally applicable to every individual’s unique health circumstances.
B. Third-Party Information
The suPARbio™ Systemic Chronic Inflammation Test and related materials may reference third-party sources, including scientific literature, clinical studies, peer-reviewed publications, or external health resources. Such references are provided for informational purposes only and do not constitute endorsement of the content, findings, or conclusions of those sources.
suPAR Biomarker LLC does not verify, control, or assume responsibility for the accuracy, completeness, or reliability of third-party information, and is not liable for any errors, omissions, or discrepancies contained therein. Users should independently evaluate referenced materials and consult qualified healthcare professionals for interpretation and clinical or wellness guidance.
C. International Use
The Test is intended for use in the United States and may be subject to varying regulatory requirements across different jurisdictions. Users are responsible for ensuring that use of the Test complies with all applicable local laws and regulations governing laboratory testing and in vitro diagnostic devices. suPAR Biomarker LLC makes no representation that the Test is appropriate, available, or legally permitted for use in all jurisdictions.
D. Updates to Disclaimer
This Disclaimer may be updated periodically to reflect changes in regulatory requirements, scientific understanding or business practices. The most current version will apply upon publication, and users are encouraged to review it prior to using the Test.
E. Privacy and Data Security
The privacy and confidentiality of your personal and health information are handled in accordance with applicable data protection laws. Please refer to our Privacy Policy for details on how your data is collected, stored, and used in connection with the Test. By using the Test, you acknowledge that you have read and understood the Privacy Policy.
F. Governing Law and Jurisdiction
This Disclaimer shall be governed by and construed in accordance with the laws of Puerto Rico, without regard to conflict of law principles. To the extent permitted by applicable law, disputes arising from or related to the use of the Test shall be subject to the exclusive jurisdiction of the courts located in Puerto Rico.
G. Informed Consent
By purchasing and using the suPARbio™ Systemic Chronic Inflammation Test, you acknowledge that you have read and understood the intended use and limitations of the Test and agree to use its use in accordance with this disclaimer.
You further consent to the collection, processing, and analysis of your biological sample as described in the accompanying documentation and in accordance with applicable privacy laws and ethical guidelines.. For any questions or concerns, you may contact suPAR Biomarker LLC at compliance@suparbio.com.
This Disclaimer is effective as of March 1st, 2026