Terms and Conditions of Clinical Service | Silver Gene Laboratories
Last Updated: June 2026
Welcome to Silver Gene Laboratories. These Terms and Conditions (“Terms”) govern your access to and institutional utilization of our clinical diagnostic website, secure provider portal, pharmacogenomics (PGx) testing services, finalized clinical reports, and associated medical communications.
By initiating a diagnostic order, accessing our digital interfaces, or utilizing our clinical reporting metrics, you agree to be bound by these Terms. If you or your health system do not agree to these structural terms, you are prohibited from utilizing our diagnostic services.
1. Scope of Clinical Diagnostic Services
Silver Gene Laboratories provides high-complexity clinical pharmacogenomic (PGx) testing services, specifically utilizing the Silver PGx Oncology Panel. These services, analytical data sets, and clinical decision support reports are engineered and intended exclusively for utilization by licensed healthcare providers and authorized clinical entities.
2. Professional Eligibility & Warranties
Access to our molecular diagnostic testing suites and secure provider portals is strictly limited to licensed physicians, medical oncologists, hematologists, and qualified clinical healthcare professionals acting within the authorized scope of their active state medical licensure. By submitting a clinical specimen or initiating a digital requisition, you represent and warrant that you possess the necessary credentials, state-level authorizations, and institutional privileges required to order and interpret high-complexity genetic diagnostics.
3. Clinical & Laboratory Developed Test (LDT) Disclaimer
The Silver PGx Oncology Panel is a Laboratory Developed Test (LDT) processed within a high-complexity facility operating under full Clinical Laboratory Improvement Amendments (CLIA) certification and College of American Pathologists (CAP) accreditation.
This panel is intended strictly to provide supplemental, evidence-based pharmacogenomic insights to assist licensed clinicians in evaluating drug selection, managing toxicities, and adjusting baseline dosing strategies. It is not intended to diagnose active malignancies, replace professional clinical judgment, or serve as the sole deterministic basis for systemic patient therapy. Finalized outcomes must be interpreted by a credentialed healthcare provider in the strict context of the patient’s complete medical presentation, comorbidity profiles, and current oncology consensus guidelines (e.g., CPIC, NCCN).
4. Order Requisitions, Patient Consent, & Compliance Safeguards
Authorized Orders Only: Diagnostic processing will only occur upon receipt of a valid, signed digital or physical requisition form submitted by an authorized, licensed provider.
Informed Patient Consent: The ordering clinician maintains sole responsibility for obtaining all legally mandated patient informed consents, genetic testing authorizations, and state-specific disclosures regarding germline DNA collection prior to specimen dispatch.
Statutory Compliance: Both parties agree to execute their respective duties in complete alignment with all applicable federal and state healthcare regulations, including the Health Insurance Portability and Accountability Act (HIPAA), the Genetic Information Nondiscrimination Act (GINA), and corresponding data security frameworks.
5. Analytical Validity, Intellectual Property, & Data Utilization
Analytical Limitations: Silver Gene Laboratories warrants the analytical validity of its processing protocols as certified under CLIA/CAP frameworks. No warranties regarding broader clinical utility or specific patient therapeutic outcomes are expressed or implied beyond standard laboratory validation metrics.
Intellectual Property Boundaries: All proprietary reporting formats, variant interpretation algorithms, testing methodologies, software interfaces, and documentation remain the exclusive intellectual property of Silver Gene Laboratories. Providers are granted a non-exclusive license to utilize finalized reports strictly for individual patient care, and may not reproduce or commercially exploit the underlying data systems.
Anonymized Data Curation: In complete compliance with federal safe-harbor standards, de-identified genomic data derived from testing pipelines may be utilized by Silver Gene Laboratories for internal quality controls, technical research, peer-reviewed publications, or operational advancements. Identifiable protected health information (PHI) will never be sold, shared, or distributed.
6. Limitations of Liability & Governing Jurisdiction
Liability Limits: To the maximum extent permitted by applicable law, Silver Gene Laboratories shall not be held liable for indirect, incidental, consequential, or punitive damages arising from the clinical application, misinterpretation, or therapeutic choices executed based on finalized genomic reports.
Governing Law: These Terms, operational protocols, and transactional integrations shall be governed by and construed in accordance with the laws of the State of Texas, without regard to conflicting statutory principles.
7. Modifications and Amendments to Clinical Terms
Silver Gene Laboratories reserves the right to periodically update, modify, or amend these Terms at our sole discretion to reflect shifts in regulatory frameworks, updates to clinical consensus guidelines, or operational facility advancements. Any structural changes will be posted directly to this page with a revised “Last Updated” date.
Your continued utilization of our provider portal, diagnostic ordering suites, or reporting metrics following the publication of amendments constitutes binding, institutional acceptance of the revised Terms. If you or your health system do not agree to the updated frameworks, you must immediately cease all specimen dispatches and terminate your portal access.
8. Corporate Contact Information
Silver Gene Laboratories 8501 Wade Blvd, Suite 1310
Frisco, TX 75034
Clinical Integration Desk:pgxinfo@silvergenelabs.com
Direct Operational Line: 972-807-0649