Genetron Health Receives CE Mark for Human B Lymphocyte Minimal Residual Disease Detection Kit Seq-MRD®
19 Abril 2022 - 5:00AM
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 received a CE Mark for its proprietary
Human B Lymphocyte Minimal Residual Disease Detection Kit
(Reversible Termination Sequencing Method), which is also known as
Seq-MRD® (Registration Number:
DE/CA20/01-IVD-Luxuslebenswelt-190/22).
Based on high-throughput next generation sequencing (NGS)
technology, Seq-MRD® assay is intended to test the CDR3 regional
sequence of the IgH/K/L gene of the B cell receptor (BCR) in bone
marrow samples collected from patients with B lymphpocytic leukemia
(B-ALL/CLL) and multiple myeloma (MM) before and after the
treatment. By screening out significant and specific clonal
rearrangement form in a patient's tumor cells, this approach can
detect minimal residual disease and provide a reference for the
follow-up treatment of cancer survivors.
The Seq-MRD® assay has been optimized with Genetron Health’s
“One-step Seq Method” technology, which enables the DNA library
construction process for gene sequencing to finish with a single
PCR and minimizes the risks of sample contamination and false
positive results. This simple operational feature, combined with
the Company’s automated bioinformatics analysis solution, enables
Seq-MRD® to have broad application prospects due to its key
technological advantages of high throughput, fast turnaround,
stability and accuracy, and high cost-efficiency. Recently, an
experiment was completed that identified the assay performance in
various perspectives, such as sensitivity, accuracy, specificity
and precision, among which, 128 clinically confirmed samples showed
a high concordance on positive detection results from the Seq-MRD®
assay and the traditional technology of flow cytometry (FCM). More
importantly, there were 10 samples detected as positive by Seq-MRD®
assay, which were identified as negative by FCM, demonstrating the
higher sensitivity of the assay.
In October 2021, Genetron Health and Jiangsu Fosun
Pharmaceutical Sales Co., Ltd (“Jiangsu Fosun Pharma”) signed an
exclusive Seq-MRD® commercialization agreement. With Jiangsu Fosun
Pharma’s sizeable, experienced, hematologic cancer focused sales
force, the two sides have been working together to co-market and
co-promote Seq-MRD® in hematologic-focused hospitals and clinics
across designated territories in China, to meet the clinical
testing needs of patients with lymphatic hematological tumors.
In addition to Seq-MRD®, Genetron Health is also actively
promoting the clinical validation and business plan 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) and other products
have successively obtained 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
Hoki Luk
Email: hoki.luk@genetronhealth.com
Phone: +1 (408) 891-9255
Media Relations Contact
Yanrong Zhao
Email: yanrong.zhao@genetronhealth.com
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