REG - Burning Rock Biotech - BNR Received Breakthrough Device Designation

Burning Rock BiotechAnnouncement

16/10/2023 07:00

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RNS Number : 1973Q  Burning Rock Biotech Limited  16 October 2023

Burning Rock Received Breakthrough Device Designation from China's NMPA for
its Multi-Cancer Early Detection Test

 

GUANGZHOU, China, October 16, 2023 (GLOBE NEWSWIRE) -- Burning Rock Biotech
Limited (NASDAQ: BNR and LSE: BNR, the "Company" or "Burning Rock") is pleased
to announce that followed an earlier Breakthrough Device Designation granted
by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer
Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been
granted Breakthrough Device Designation by the China National Medical Products
Administration(NMPA), which represents the only test globally that has
received Breakthrough Device Designation from both US FDA and China NMPA.

 

OverC™ MCDBT is intended for early detection of multiple cancer types in
adults of either sex, aged 50-75 years old, at average risk for cancer.
OverC™ MCDBT demonstrated a 69.1% of sensitivity and 98.9% of specificity in
the case-control study, THUNDER, and achieved a superior tissue traceability
capabilities-the prediction accuracy of TPO1 (primary traceability organ) and
TPO2 (primary and secondary traceability organs) was 83.2% and 91.7%,
respectively. The technology and validation data have been released on Annals
of Oncology in March 2023, showing an impressive performance of ELSA-seq using
cfDNA in cancer detection and origin prediction.

 

Mr. Yusheng Han, founder and CEO of Burning Rock, said, "We are very inspired
that our multi-cancer early detection product has received recognition from
both US and China regulatory authorities. We obtained our first Breakthrough
Device Designation from China NMPA in 2016 for NGS-based therapy selection
test, and the China NMPA Breakthrough Device Designation granted for OverC™
MCDBT would pave the way for a clearer registration path through confirmative
performance validation and utility establishment. Burning Rock will actively
strive to promote the clinical research process, technological innovation, and
industry development."

 

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR), whose mission is to
guard life via science, focuses on the application of next generation
sequencing (NGS) technology in the field of precision oncology. Its business
consists of i) NGS-based therapy selection testing for late-stage cancer
patients, and ii) cancer early detection, which has moved beyond
proof-of-concept R&D into the clinical validation stage.

 

For more information about Burning Rock, please visit: www.brbiotech.com.

 

Enquiries:

Contact: IR@brbiotech.com

 

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