REG - Burning Rock Biotech - BNR Received FDA Breakthrough Device Designation

Burning Rock BiotechAnnouncement

03/01/2023 15:00

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RNS Number : 5528L  Burning Rock Biotech Limited  03 January 2023

Burning Rock Received FDA Breakthrough Device Designation for its OverC™
Multi-Cancer Detection Blood Test

 

IRVINE, Calif. Jan.03, 2023 - Burning Rock (NASDAQ/LSE: BNR), a company
focused on the application of next generation sequencing (NGS) technology in
the field of precision oncology, today announced that its OverC™
Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device
Designation by the US Food and Drug Administration (FDA), which is the third
of its kind globally.

 

Under the FDA's Breakthrough Devices Program, the Breakthrough Device
Designation is granted to certain medical devices that provide for more
effective treatment or diagnosis of life-threatening or irreversibly
debilitating diseases or conditions such as cancer. This program is designed
to provide patients and healthcare providers with timely access to medical
devices granted the designation by speeding up their development, assessment,
and review.

 

OverC™ MCDBT is intended for early detection of multiple cancer types
(esophageal, liver, lung, ovarian, and pancreatic cancers) 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 will be further validated in prospective
interventional studies among asymptomatic population. Test results of
"Detected" with the top one or two predicted tissues of origin of
cancer-associated signals may indicate the presence of cancer and should be
followed up by diagnostic tests suggested by qualified healthcare
professionals in accordance with professional guidelines. Test results of
"Undetected" do not rule out the presence of cancer, and individuals should
continue with guideline-recommended standard of care screening tests.

 

Compared with conventional cancer screening methods, liquid biopsy has the
potential to increase detection efficiency and enable early diagnosis and
treatment, thus improving patients' survival and quality of life while
reducing social burden of the disease. Burning Rock started development of
multi-cancer early detection technology based on DNA methylation in 2016, and
the technology and validation data have been presented at ASCO
(https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.10544) , ESMO
(https://oncologypro.esmo.org/meeting-resources/esmo-congress/a-multi-cancer-early-detection-model-based-on-liquid-biopsy-of-multi-omics-biomarkers-a-proof-of-concept-study-promise-study)
and other medical conferences, as well as journals such as Nature Biomedical
Engineering ( 1 ), demonstrating high specificity, sensitivity, and accuracy
in predicting the tissue of origin. In May 2022, Burning Rock received CE mark
for its OverC™ MCDBT manufactured in both the US and China facilities.
Today, the FDA Breakthrough Device Designation granted for OverC™ MCDBT
would pave the way for a clearer registration path through confirmative
performance validation and utility establishment.

 

Mr. Yusheng Han, founder and CEO of Burning Rock, said, "We are very excited
that our cfDNA methylation multi-cancer early detection technology has
received FDA Breakthrough Device Designation. For cancer, early diagnosis and
treatment are the key to the long-term survival of patients. Liquid
biopsy-based early detection technology will be an important supplement to the
current cancer screening methods, especially for ovarian cancer, pancreatic
cancer and other cancers that have no effective screening methods up to now.
Burning Rock has also launched two prospectively collected case-control
studies, PREDICT and PRESCIENT, with more than 10,000 subjects to be enrolled,
to continue developing OverC™ MCDBT to cover more cancer types. With our
promising clinical research data, we believe that over time our collective
effort is going to make significant impact towards the improvement of cancer
patients' lifespan and quality of life."

 

Reference

 1  Liang N, Li B, et al. Ultrasensitive detection of circulating tumour DNA
via deep methylation sequencing aided by machine learning. Nat Biomed Eng.
2021 Jun;5 (6):586-599.

 

 

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: 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
(https://www.globenewswire.com/Tracker?data=YUcU0ESxWhaQKt1ZVapBSw15NNxU4EmDKZOcVd-78oCycTwgKoHWq0jsLWajuQK6Ykw68vQ9LLPTVpWqlB3Qkw==)

 

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