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 use in overall wellness and may serve s an aid in assessing systemic chronic inflammation status in adults which can provide insight into the impact diet, exercise and stress reduction on general wellness It may also be used f over time to evaluate changes in inflammation status. This Test is not intended to diagnose, treat, cure, or prevent any specific disease or medical condition. Results are provided for informational and wellness 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 determine what health, wellness and lifestyle changes may be appropriate if you have elevated markers for systemic chronic inflammation. Your healthcare provider is best equipped to interpret the results in the context of your overall health history. Do not ignore professional medical advice or delay seeking medical care based on the information provided by the Test. Always seek the advice of your healthcare provider for any questions regarding a medical condition or treatment.
3. FDA Status Disclosure
This Test has been validated by a CLIA-certified laboratory as a Laboratory Developed Test (LDT). It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The Test is performed and interpreted within a CLIA-certified laboratory environment and is subject to applicable federal and state laboratory regulations. No representation is made that the Test has undergone FDA review or is FDA-cleared or approved.
4. Interpretation Responsibility
suPAR is a non-specific biomarker of systemic chronic inflammation. According to studies, elevated suPAR levels may be observed in relation to a wide range of conditions, including but not limited to acute or chronic inflammatory states, infection, cardiovascular disease, metabolic conditions, chronic kidney disease, and stress-related inflammatory burden. Because suPAR is non-specific, results must be interpreted by a licensed healthcare provider. suPAR Health 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
The use of the Test and reliance on its results are solely at your own risk. suPAR Health LLC and its affiliates, licensors, and suppliers shall not be held liable for any loss, damage, or harm arising from the use of the Test, reliance on the results, or any decision made based on the information provided. By using the Test, you agree to release suPAR Health LLC from any and all liability associated with its use, including but not limited to incorrect interpretations, improper usage, or adverse outcomes.
6. Biological Age Index
Where reported, the suPARbio™ Biological Age Index represents a statistical estimate derived from population-level reference data and reflects the chronological age at which a measured suPAR value is typical among healthy individuals of the same sex within a defined reference population. The Biological Age Index is a statistical model and is not a diagnostic tool, nor is it a definitive measure of physiological age. It should not be interpreted as proof of accelerated or decelerated aging. Reference ranges are derived from Northern European populations and may not be universally applicable across all ethnic 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, officers, contractors, laboratory partners, or representatives. The Test results and any accompanying information are not intended to create such a relationship and should not be construed as medical advice, diagnosis, or treatment. suPAR Biomarker LLC does not provide clinical care. All medical questions, concerns, and treatment decisions must be directed to a licensed healthcare provider.
8. No Liability in Laboratory Sample Processing
suPAR Biomarker LLC assumes no liability for any errors, delays, or issues arising during laboratory 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 diagnostic or informational tool is without limitations. The accuracy and reliability of the Test may be influenced by multiple factors, including but not limited to sample quality, proper collection and handling procedures, laboratory variables,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 information, including clinical studies, peer-reviewed research, or external health resources. While reasonable efforts are made to ensure the accuracy and reliability of such information, suPAR Biomarker LLC does not assume responsibility for any errors, omissions, or discrepancies in third-party data or publications. Users are encouraged to independently evaluate referenced materials and consult qualified healthcare professionals for interpretation and guidance.
C. International Use
The Test is subject to varying regulatory requirements in different jurisdictions. Users outside the European Union and the United States are responsible for ensuring compliance with local laws and regulations governing in vitro diagnostic devices. suPAR Biomarker LLC makes no representation regarding the availability or legality of the Test in any particular location.
D. Updates to Disclaimer
This Disclaimer may be updated periodically to reflect changes in regulatory requirements, scientific advancements, or business practices. Users are encouraged to review the most current version of the Disclaimer before using the Test.
E. Privacy and Data Security
The privacy and confidentiality of your personal and health information are of utmost importance to us. Please refer to our Privacy Policy for details on how your data will be collected, stored, and used in connection with the Test. By using the Test, you agree to the terms of our Privacy Policy.
F. Governing Law and Jurisdiction
This Disclaimer shall be governed by and construed in accordance with the laws of Puerto Rico. Any disputes arising from 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 limitations and intended use of the Test, accept its limitations and agree to use it responsibly in consultation with a healthcare provider. You further consent to the collection, analysis, and reporting of your biological sample as described in the accompanying documentation. Your sample will be handled in compliance with applicable privacy laws and ethical guidelines. For any questions or concerns, please contact suPAR Biomarker LLC at compliance@suparbio.com.
This Disclaimer is effective as of March 1st, 2026