Burning Rock Biotech Limited BNR Received FDA Breakthrough Device Designation (5528L)
January 03 2023 - 9:53AM
UK Regulatory
TIDMBNR
RNS Number : 5528L
Burning Rock Biotech Limited
03 January 2023
Burning Rock Received FDA Breakthrough Device Designation for
its OverC(TM) 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(TM) 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(TM) 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(TM) 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 , ESMO
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(TM) MCDBT
manufactured in both the US and China facilities. Today, the FDA B
reakthrough Device Designation granted for OverC(TM) 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(TM) 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
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