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Lab authorized by US CLIA on tumor clinical detection | Updated:2017-10-23

A joint laboratory established by Burning Rock, a Chinese medical enterprise treating tumor patients and Chinese Thoracic Oncology Group were certified on circulating tumor DNA (CTDNA) and tumor tissue second-generation sequencing (NGS) clinical testing, on Feb 16.


Burning Rock & CTONG Laboratory is now CLIA certified. [Photo/]

The certificate issued by the US Clinical Laboratory Improvement Act (CLIA), makes the lab the first and only one of its kind in China.

The joint laboratory has also passed the review by the US Center of the Medical Insurance and Medicaid Services (CMS) of the US Department of Health and Human Services (HHS).

The certification took effect on Jan 26, 2017. Since then, all Burning Rock's testing products for different stages and various types of cancer have been examined under a CLIA-certified quality management system to ensure accurate test results.

CLIA is the eligibility requirements applied by the US government on clinical laboratory enforcement of all human test specimens for health assessment, disease diagnosis, prevention, and treatment, and it is also an internationally recognized authoritative certification standard.


Burning Rock is a medical company committed to providing the most valuable and precise tests for medical care. [Photo/]

Han Yusheng, the CEO of Burning Rock said that the company is committed to providing accurate clinical results and products with high quality standards. The CLIA certification ensures that Burning Rock's testing meets international standards and is under the supervision of the international authority. CLIA reports are all recognized by the international market.

Burning Rock & CTONG joint laboratory is a research laboratory for second generation gene sequencing (NGS) and deals with all the processes of second generation gene sequencing including, sample preprocessing, nucleic acid extraction, library construction and sequencing, and data analysis. It is mainly used for non-profit clinical research.

Located at the Guangzhou International Bio Island, the joint laboratory covers an area of about 3,000 square meters and was put into use in September 2016. 


Burning Rock & CTONG joint laboratory is located at the Guangzhou International Bio Island. [Photo/]


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