NATA has accredited BGI Australia’s laboratory to perform clinical Whole Exome Sequencing in Australia.
The BGI Australia laboratory will provide clinical services in Australia for the first time after receiving accreditation in NATA’s Human Pathology accreditation program.
In addition to compliance to ISO 15189, BGI also meets the accreditation standards for pathology laboratories set by the National Pathology Accreditation Advisory Council (NPAAC).
The accreditation will facilitate BGI Australia to provide services to clinical laboratories, hospitals, and other partners to detect changes in the exome that contributes to rare genetic and paediatric diseases.
Building on lessons from the accreditation process, BGI Australia will look to expand its testing scope and demonstrate its capabilities in clinical solutions, as well as seek partnerships in technology transfer to make testing more accessible to the community.
Dr. Bicheng Yang, Director of BGI Australia noted that:
“NATA’s accreditation procedures are extremely rigorous, and it is a significant achievement that our laboratory, the MGI DNBSEQ-G400 platform that performs clinical Whole Exome Sequencing, and the procedures implemented by our technicians, have qualified for the NATA accreditation. We will continue to improve and increase the accessibility of clinical sequencing to clinical laboratories, research institutes and hospitals.”
“Everything must meet NATA’s quality system requirements, including a four-layer document system of Quality Management, Quality Procedure, Standard Operating Procedures, and Record Management. To ensure continued compliance to all quality standards, the laboratory will be regularly reviewed by NATA.”
Data communication, storage and the process for data deletion are also a critical part of NATA’s accreditation of the BGI Australia laboratory, which operates a closed loop system.
Globally, BGI Group has more than 100 international quality system certifications, which govern how its laboratories operate and ensure the company meets all local regulations, particularly around data regulation and personal privacy.
The multi-month NATA accreditation process required BGI Australia to meet independent assessment of the laboratory, including personnel competence, equipment, quality assurance of process controls and sample handling, plus data security and confidentiality.