DEKRA Certification has awarded ISO 9001:2008 certification to MDxHealth's CLIA certified and College of American Pathologists (CAP) accredited laboratory in Irvine, California, US.
The certification confirms that MDxHealth's quality management system meets customer and regulatory requirements for research, product design, assay development and clinical molecular diagnostic services and pharmaco clinical trials testing.
MdxHealth CEO Jan Groen said the ISO certification for the quality management system, in combination with CLIA certification and CAP accreditation, demonstrates the company's commitment to uphold the better quality standards in assay development and clinical diagnostic testing.
"As companion diagnostic assays play an increasingly important role in the development and validation of new cancer therapies, pharmaceutical companies recognize the importance of quality control even at the earliest stages of Research and Development," Groen added.
"The ISO certification of our Irvine facility further strengthens our position as a global partner for PharmacoMDx test development."
The molecular diagnostics company develops and commercializes epigenetic tests for cancer assessment and the personalized treatment of patients.
