IRVINE,
Calif., Jan. 3, 2023 /PRNewswire/ -- 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.
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SOURCE Burning Rock