Laboratory accreditation is a benchmark for maintaining the performance competence of clinical tests. Since genetic testing using next-generation sequencing (NGS) technology is more complicated in terms of test performance and the interpretation of results compared to traditional molecular diagnosis methods, the College of American Pathologists (CAP) established the NGS Team in 2011, and published the first NGS Accreditation Requirements in 2012. Such requirements are revised annually as NGS clinical testing is advancing rapidly with growing diversity in its applications.

Our clinical testing laboratory in China is certified to the international clinical laboratory standards, including CAP, CLIA and ISO15189, as well as national/provincial certifications for clinical genetic testing. We are also actively involved in numerous international and local NGS proficiency testing (PT) to ensure that our NGS tests are in compliance with various clinical applications.

Our clinical testing laboratory is accredited by  

Our CDx kit manufacturing facility is accredited by

ISO 13485:2016

See Certificate

We successfully passed 250+ external quality assessments and proficiency testing by