Genetron Health Receives CE Mark for FusionScan Plus Kit for Human Multi-Genes
01 Juin 2022 - 12:00PM
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 it has obtained a CE Mark for its FusionScan Plus
Kit, an integrated DNA and RNA NGS-based assay for simultaneously
detecting multiple gene mutations and fusions with lower
thresholds, (Registration number:
DE/CA20/01-IVD-Luxuslebenswelt-886/22).
Receipt of the CE Mark is an important step for the acceleration
of FusionScan Plus’s global footprint, and its potential to enter
more international clinical trials in the future.
Based on Genetron Health’s One-Step™ Seq Method, FusionScan Plus
covers 29 tumor-related mutant genes, and 40 fusion genes.
FusionScan Plus breaks through the limitations of traditional
detection methods. With lower threshold requirements and a faster
process, it can simultaneously detect sensitive or drug-resistant
gene mutations at the DNA level, and the known and unknown partner
genes fusions at the RNA level, in tumor tissue samples. It can
provide an effective reference for clinical pathological
classification, formulation of targeted treatment strategies and
new drug development.
Genetron Health revealed the study results on FusionScan Plus at
the Association for Molecular Pathology 2021 Annual Meeting. The
detection results of 76 clinical formalin-fixed paraffin-embedded
(FFPE) samples proved that FusionScan Plus shows high accuracy in
the detection of gene mutations and fusions without a priori
knowledge of 5’ fusion partner. It can accurately detect drug sites
for cancer patients and screen the population for targeted
therapies, even with limited biopsy samples, thus improving the
clinical benefits of patients.
Genetron Health has been actively promoting the clinical
validation and business distribution of multiple IVD products in
domestic and overseas markets. Currently, Human IDH1 Gene Mutation
Detection Kit (PCR-fluorescent probe method), Human TERT Gene
Promoter Mutation Detection Kit (PCR-fluorescent probe method),
Human 8-Gene Mutation Joint Detection Kit (semiconductor sequencing
method), Human 825 Gene Mutation Detection Kit (combined
probe-anchored polymerization sequencing method), Human B
Lymphocyte Minimal Residual Disease Detection Kit (reversible
termination sequencing method) and other products have successively
obtained the EU’s CE mark. In the future, the Company will closely
follow the clinical needs of molecular detection, accelerate the
commercialization of products, and provide patients with more
precise and accessible medical services.
About CE Mark
The CE mark stands for CONFORMITE EUROPEENNE, a
security-certified mark, and is seen as a passport for
manufacturers to open and enter the European market. In the EU
market, the CE mark is a compulsory certification mark, whether it
is a product produced within the EU enterprise or a product
produced in other countries. In order to circulate freely in the EU
market, a CE mark must be added to indicate that the product meets
the basic requirements of the EU. For more
information:https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
About Genetron Holdings Limited
Genetron 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 Statement
This press release contains 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 Contact
Email: ir@genetronhealth.com
Media Relations Contact
Yanrong ZhaoEmail: yanrong.zhao@genetronhealth.com
Genetron (NASDAQ:GTH)
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