IncellDx, which focuses on critical life threatening diseases such as HIV/AIDS, HPV/Cervical Cancer, Hepatitis, organ transplant infections, breast cancer and ovarian cancer, has received ISO 13485:2003 certification.
The company simultaneously achieved ISO 9001:2008 certification, with zero deficiencies.
IncellDx is focused on providing quality information to enhance patient care and the company will be pursuing FDA regulatory approval for its HPV assay with a clinical trial planned in 2011.
IncellDx founder, president and CEO Bruce Patterson said these awards are the culmination of a year long, concerted effort to put in place a truly state-of-the-art quality management system.
"This system reflects our continuing commitment to provide our customers with the very highest quality products possible," Patterson said.
Theodore Zafiropoulos MD of CZ Group and Flowcytogen Laboratories in Athens, Greece, said obtaining ISO certifications demonstrates IncellDx’s strong commitment to its customers.