Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test
03 Enero 2023 - 8:25AM
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,
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™ 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
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