BGI Group obtains the first clinical laboratory certification in Australia

On October 20, 2022, the Australian National Association of Testing Agencies (hereinafter referred to as NATA) officially awarded BGI Genomics Laboratory's clinical whole exome sequencing quality system accreditation certificate, which is the first clinical laboratory certification obtained by BGI Group in Australia, which will help its clinical sequencing services in
Australia.

Although exons make up only 1%-2% of the human genome, they contain 85% of known disease-causing mutations
in exons.
Clinical whole exome sequencing is an efficient, economical and commonly used genome sequencing method
for the detection of all exons of all human genes, which is suitable for the diagnosis of complex genetic diseases that are difficult to determine the cause.

The NATA accredited laboratory is located in Brisbane, Australia, with a laboratory area of about 460 square meters
.
After certification, BGI will provide clinical whole exome sequencing services for clinical laboratories, hospitals and other medical institutions in Australia to detect rare diseases and pediatric diseases caused by changes in exons
.
The relevant tests will be based on the high-throughput sequencer DNBSEQ-G400 made by BGI, a subsidiary of BGI Group, which is certified
by the Australian Medicines Agency (TGA).

NATA is the world's first comprehensive laboratory accreditation body and currently one of the largest accreditation bodies in the
world.
BGI's application for NATA clinical whole exome sequencing laboratory certification adopts the internationally recognized ISO15189 standard and complies with the pathology laboratory accreditation standards
formulated by the National Pathology Accreditation Advisory Committee (NPAAC).

As an industry-recognized pioneer and leader in laboratory testing, NATA certification standards are more stringent
than similar institutions in Europe and North America.
In addition to the reliability of the laboratory's processes, NATA's evaluation will also consider the competence, qualifications and equipment of personnel, and require that the operating system of the entire laboratory strictly meets its requirements
for quality management and monitoring.
Among them, NATA has more stringent requirements for samples in methodological validation than standards in other countries—in addition to standards, it also requires a more diverse range of clinical sample sources
.
In order to meet the evaluation requirements of NATA, BGI also tested about 50 clinical samples in addition to standards, and finally produced hundreds of data results to ensure the accuracy and reproducibility of
the experiment.

"In the future, we will continue to expand the scope of clinical testing in this laboratory and provide more reliable clinical testing services
.
At the same time, we also look forward to establishing more cooperation to extend the output of clinical sequencing capabilities to a wider range of regions and populations, and jointly promote gene technology to benefit mankind
.
" ”

"The UW team is one of
the best I've ever worked with.
" Dr.
Peter Kaub, an independent clinical pathologist and NATA certification consultant, said, "Achieving NATA accreditation means that the laboratory can now provide clinical whole exome sequencing services to laboratories or hospitals in need, and will also help more patients get test results
in a more timely manner.
" ”

BGI Group has been committed to building an international high-quality laboratory, providing accurate and reliable test results for partners, establishing a comprehensive quality management system, covering scientific research cooperation, clinical services, instrument manufacturing, reagent production, data analysis, etc.
, and has passed quality, environment, occupational health and safety, information security, personal information and other related management system certification
.
"As early as 2011, BGI's medical laboratories have passed ISO17025 accreditation, which is the first institution
in the industry to obtain ISO17025 accreditation.
This NATA certification is another authoritative recognition
of BGI's comprehensive quality management system.
Wei Fu, Director of BGI's Gene Quality Management Department, added
.

At present, BGI Group has more than 100 international quality system certifications
.
Yin Ye, CEO of BGI, said: "As the world's leading frontier institution in life sciences, BGI Group continues to lead the development of the industry, which is inseparable from the emphasis
on quality management.
We will continue to adhere to the synchronous development of science, technology, standards, quality and intellectual property rights, and hope to empower the world based on China's manufacturing, and drive the healthy and orderly development of
the industry through quality leadership.
”