At HalioDx, we are committed to compliance with all laws, rules and regulations governing our business and strictly adhere to all our own internal policies and procedures, including the Health Insurance Portability and Accountability Act (HIPAA), the General Data Protection Regulation (GDPR) and others.
HalioDx 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, HalioDx is a participating provider for the Medicare program.
We deliver CLIA & CE-IVD Immunoscore® results to patients worldwide:
CLIA n° 49D2159558
CLIA for California n° COS 00800961
CLIA for Maryland n° 2983
CLIA for Pennsylvania n° 36968
CLIA for Rhode Island n° LCO01317
CLIA n° 99D2131292
CLIA for California n° COS 00800828
CLIA for Maryland n° 2730
CLIA for Pennsylvania n° 35816
With more than 33,000 squared meters of advanced facilities using ISO 13485 & ISO 9001 quality management system, HalioDx has the full capacity to manage and analyze samples from Clinical Trials in accordance with GCP and GCLP.