Research Use Only (RUO) Acknowledgment
This laboratory assay is offered for Research Use Only (RUO). It has not been cleared or approved by the United States Food and Drug Administration (FDA) for diagnostic or clinical use. Results are provided for research and informational purposes within a practitioner-directed framework.
Non-Diagnostic Use Statement
I understand that results generated through this program are not intended to diagnose, treat, cure, mitigate, heal, or prevent any disease and should not be used as the sole basis for medical decision-making.
Practitioner Responsibility
I acknowledge that I am solely responsible for interpretation of results, communication with my patient/participant, and any clinical decisions made within my professional scope of practice. Javelin Sciences does not practice medicine and does not provide treatment recommendations.
Marketing & Representation Restriction
I agree that I will not market, advertise, or represent this assay as diagnostic, FDA-cleared, or clinically validated for disease detection. I will accurately describe the assay as Research Use Only.
De-Identified Data Use Authorization
I understand that de-identified data derived from testing may be used by Javelin Sciences for research, quality improvement, validation studies, and program development purposes.
I attest I am a licensed healthcare professional acting within scope.
I understand this testing program is Research Use Only (RUO) and not diagnostic.
I understand results are not intended to diagnose, treat, cure, mitigate, heal, or prevent.
I agree results will be interpreted within a practitioner-patient relationship.
I agree not to market this test as diagnostic.
I acknowledge results will be delivered only to me.
I am responsible for communicating results to participant.
I agree to maintain HIPAA compliance within my practice.
Submission of this form does not guarantee program approval. Javelin Sciences reserves the right to approve or deny practitioner enrollment at its discretion.