Genetron Health Receives U.S. FDA Breakthrough Device Designation for its Blood-based NGS Test for Early Detection of Hepatoc...
September 30 2020 - 8:10AM
Genetron Holdings Limited (“Genetron Health” or the “Company”,
Nasdaq: GTH), a leading precision oncology platform company in
China that specializes in offering molecular profiling tests, early
cancer screening products and companion diagnostics development,
today announced that its blood-based next-generation sequencing
(NGS) test, HCCscreenTM, has been granted Breakthrough Device
designation by the U.S. Food and Drug Administration (FDA). Based
on the correspondence with Center for Devices and Radiological
Health (CDRH) of the FDA, HCCscreenTM is intended for early
detection of hepatocellular carcinoma in individuals who are
designated to be at high-risk for HCC due to chronic HBV infection
and/or liver cirrhosis.
Under the FDA’s Breakthrough Devices Program,
the Breakthrough Device designation is granted for products that
have the potential to offer more effective diagnosis of
life-threatening diseases with an unmet medical need. The program
is designed to speed up development, assessment and review
processes, in order to provide patients with quicker access to
those devices. Genetron Health’s HCCscreenTM was granted based on
its superior clinical performance over the current standard of care
(i.e., ultrasound plus alpha-fetoprotein (AFP)) in a prospective
clinical study. With this designation, the Company will have an
opportunity to interact with the FDA's experts to efficiently
address topics through the pre-submission process, so as to receive
feedback from the FDA and identify areas of agreement in a timely
way. It also allows priority review upon premarket approval (PMA)
submission, and Medicare coverage by the CMS (Center for Medicare
and Medicaid Services) upon formal approval.
Genetron Health intends to develop HCCscreenTM
as an NGS-based product in the US. The company is also building a
lab in Maryland, which it intends to seek CLIA certification, to
serve global pharmaceutical companies on R&D and
commercialization. In China, HCCscreenTM has recently been
commercialized as a lab developed test (LDT). The Company has five
laboratories in China, of which the Beijing lab is one of the few
domestic labs that are both CAP and CLIA certified.
HCCscreenTM is powered by Genetron Health’s
innovative and proprietary Mutation CapsuleTM technology, which
enables detection of multiple methylation alterations in parallel
with mutations in cell-free DNA from peripheral blood specimens.
Currently, HCCscreenTM is being tested in its ongoing prospective
study with 4,500 HBsAg+ individuals. As of the date of this
announcement, 2,000 patients have already completed the study, and
preliminary data from 297 patients at one center has demonstrated
over 92% sensitivity and 93% specificity, compared to 67% and 99%,
respectively in the ultrasound + AFP arm. HCCscreenTM also achieved
a 35% positive predictive value and 99.6% negative predictive
value. Furthermore, stratifying by tumor sizes, of the 12 patients
identified with HCC in the preliminary dataset, ten patients had
tumor sizes of less than five centimeters, indicating HCCscreenTM’s
detection ability in early-stage HCCs. The company expects to
announce the full data set from all 2,000 patients in the first
half of 2021.
Globally, liver cancer is the fourth most common
cause of cancer-related death and the sixth in terms of incidence1.
China represents the largest market, accounting for almost half of
the global incidences. New incidence in China was estimated to be
around 393,000 per year, with 369,000 deaths2. Market data by Frost
and Sullivan estimated that as of 2019, among the 120 million high
risk liver cancer population in China, around 74 million were HBV
carriers. In the US, liver cancer is the fifth leading cause of
cancer death in all ages, and it is increasing by 2% to 3%
annually. New liver cancer cases in US was estimated to be 42,810
in 2020, with 30,160 deaths3. HCC represents the major histological
type of liver cancer, accounting for 85–90% of cases4. Moreover,
there is no effective therapy for advanced stage HCC. Previous
estimates showed that the one-year survival for HCC in the United
States is less than 50%, while the five-year survival is 10%5.
Early detection of HCC is an unmet medical need. Current guidelines
recommend at-risk patients undergo testing every six months using
ultrasound with or without the AFP blood test6.
“We are very pleased with the FDA's recognition
of HCCscreenTM’s potential as a more effective test for early
detection of hepatocellular carcinoma. This designation also
represents a significant milestone for our plan to expand
HCCscreenTM’s geographical reach. Hepatocellular carcinoma is one
of the leading causes of cancer deaths globally, and an accurate,
easy to use, blood-based early screening test would offer
tremendous clinical value,” commented Sizhen Wang, Genetron
Health’s co-founder and CEO. “Our HCCscreenTM asset has shown
promising preliminary data in all key metrics including
sensitivity, specificity, and positive predictive value. Notably,
most of the confirmed HCC patients in the study had tumor sizes
below five centimeters. This level of performance is highly
encouraging as detecting tumor presence while they are small allows
effective early interventions, which could lead to better outcomes.
Our goal is to continue to make clinical progress in order to
potentially bring HCCscreenTM to more patients globally. This FDA
designation represents the first, yet an important step, in our
effort to achieve that goal.”
Notes:
- Villanueva, A. Hepatocellular
Carcinoma. N. Engl. J. Med. 2019, 380, 1450–1462.
- Globocan 2018.
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
- National Institute of
Health. https://seer.cancer.gov/statfacts/html/livibd.html
- Wong MCS, et al. (2018) The
changing epidemiology of liver diseases in the Asia-Pacific region.
Nature reviews. Gastroenterology & hepatology
- Altekruse SF, McGlynn KA, Reichman
ME. Hepatocellular carcinoma incidence, mortality, and survival
trends in the United States from 1975 to 2005. J Clin Oncol
2009;27:1485–91
- Harris PS, Hansen RM, Gray ME, et
al. Hepatocellular carcinoma surveillance: An evidence-based
approach. World J
Gastroenterol. 2019:25(13):1550-1559
About Genetron Holdings
LimitedGenetron Holdings Limited (“Genetron Health” or the
“Company”) (Nasdaq:GTH) is a leading precision oncology platform
company in China that specializes in cancer molecular profiling and
harnesses advanced technologies in molecular biology and data
science to transform cancer treatment. The Company has developed a
comprehensive oncology portfolio that covers the entire spectrum of
cancer management, addressing needs and challenges from early
screening, diagnosis and treatment recommendations, as well as
continuous disease monitoring and care. Genetron Health also
partners with global biopharmaceutical companies and offers
customized services and products. For more information, please
visit ir.genetronhealth.com.
Safe Harbor StatementThis press
release contains forward-looking statements within the meaning of
federal securities laws, including the HCCscreenTM study results
and statements regarding the prospects and plans for
commercializing HCCscreenTM in the United States , which involve
risks and uncertainties that could cause the actual results to
differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are
made under the “safe harbor” provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Statements that are not
historical facts, including statements about the Company’s beliefs
and expectations, are forward-looking statements. Forward-looking
statements involve inherent risks and uncertainties, and a number
of factors could cause actual results to differ materially from
those contained in any forward-looking statement. In some cases,
forward-looking statements can be identified by words or phrases
such as “may”, “will,” “expect,” “anticipate,” “target,” “aim,”
“estimate,” “intend,” “plan,” “believe,” “potential,” “continue,”
“is/are likely to” or other similar expressions. Further
information regarding these and other risks, uncertainties or
factors is included in the Company’s filings with the SEC. All
information provided in this press release is as of the date of
this press release, and the Company does not undertake any duty to
update such information, except as required under applicable
law.
Investor Relations ContactsUS:Hoki
LukHead of Investor
RelationsEmail: hoki.luk@genetronhealth.comPhone: +1 (408)
891-9255
Stephanie CarringtonWestwicke, an ICR
CompanyEmail: Stephanie.Carrington@westwicke.comPhone: +1
(646) 277-1282
Asia:Bill ZimaICR,
Inc.Email: bill.zima@icrinc.comGenetronIR@icrinc.com
Media Relations ContactEdmond
LococoICREdmond.Lococo@icrinc.comMobile: +86
138-1079-1408genetron.pr@icrinc.com
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