Compliance

LICENSes & Certifications

Veracyte Labs VA is licensed under the Clinical Laboratory Improvement Amendment of 1988 (“CLIA”) and is authorized to provide diagnostic laboratory services in the states of California, Maryland, Pennsylvania and Rhode Island. In addition, Veracyte Labs VA is a participating provider for the Medicare program.We deliver CLIA Immunoscore® results to patients worldwide.

With more than 33,000 square meters of advanced facilities using ISO 13485 & ISO 9001 quality management system, Veracyte Labs FR (Marseille, France), develops and manufactures IVD MD.

In addition, Veracyte Labs FR site in Marseille, France has the full capacity to manage and analyze samples from Clinical Trials in accordance with GCP and GCLP.

Accreditations:

Quality POLICY

Veracyte SAS, formerly HalioDx, is a global diagnostics company that improves patient care by answering important clinical questions to inform diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. Our immuno-oncology diagnostic products and services are used to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies.

Our solid expertise for more 20 years in the development and manufacturing of clinical diagnostic products is applied with the same rigorous and reliable processes for the development and execution of services for biopharma companies in compliance with applicable laws and regulations.

We promote continuous improvement at all levels of the company. Veracyte SAS ensures the continuing effectiveness of our Quality Management System throughfully trained, committed and engaged workforce, establishment of quality objectives focused on operational excellence, robust design & development, and a commitment to constant improvement of our products, services and processes applying risk-based approaches. Furthermore, we are very attentive on our customers’ feedback and needs to provide the most adapted solutions in line with market evolution.

This Quality Policy is integral to our success as a market leader and strategic partner to our customers.