Cancer Cell Diagnostics

Compliance

Regulatory Statement of Compliance

Cancer Cell Diagnostics holds itself to high standards of regulatory compliance, quality and patient safety. Our laboratory operations follow applicable federal, state and local requirements.

Certifications, Accreditations and Licenses

CLIA

Fully certified under CLIA 10D2312417, with ongoing compliance to CLIA quality standards.

CAP

CAP #9892396. CCDx is in the process of becoming CAP-accredited under the CAP Laboratory Accreditation Program.

HIPAA and Data Privacy

Patient health information is safeguarded under HIPAA and other privacy rules, including requirements tied to CMS, OIG and state law. We are pursuing licensure and registration in all required jurisdictions and follow FDA guidance for laboratory-developed tests.

Ethics and Transparency

We comply with the federal Anti-Kickback Statute, the Stark Law, the Eliminating Kickbacks in Recovery Act (EKRA) and the Sunshine Act.

Compliance Program

  • A designated Compliance Officer and a Quality Management team
  • A written Code of Conduct and corporate compliance policies
  • Regular employee training on compliance, privacy and quality
  • Auditing and monitoring of laboratory operations
  • Corrective and Preventive Action (CAPA) processes for addressing issues promptly

We are committed to continuous improvement, transparency and collaboration with regulators, providers and patients in delivering accurate, timely and reliable molecular genetic testing.

Policies and Disclaimers

  • Notice of Privacy Practices (NPP)
  • Patient rights and responsibilities
  • Anti-bribery and anti-kickback statements (Stark, EKRA)
  • Transparency policies, including Sunshine Act reporting

Ethics and Code of Conduct

  • Laboratory code of ethics
  • Conflict of interest disclosure statements, kept confidential by the Compliance department
  • A Code of Conduct that guides employee ethics and decision-making

Data Security

  • Secure infrastructure to protect patient health information
  • Encryption at rest and in transit
  • Role-based access controls

Policy documents will be linked here once CCDx supplies the current versions.

Test Classification

CellSight™ DNA is a laboratory-developed test. It was developed and its performance characteristics determined by Cancer Cell Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. Results should be interpreted by a qualified healthcare provider in the context of the patient's clinical history.

Report a Compliance Concern

To report a concern or suspected violation, email compliance@cancercelldx.com.