Genetron Health Receives CE Mark for 8-Gene Lung Cancer Assay and Provides FDA Reference Panel Comparative Data of its SARS-C...
13 July 2021 - 10:30PM
Genetron Holdings Limited (“Genetron Health” or the “Company”,
NASDAQ:GTH), a leading precision oncology platform company in China
that specializes in molecular profiling tests, early cancer
screening products and companion diagnostics development, today
announced that it has received CE Mark for its 8-gene Lung Cancer
Assay. Separately, the Company also reported comparative data
showing the sensitivity performance of the Genetron SARS-CoV-2 RNA
Test.
The CE Mark represents the second regulatory milestone for
8-gene Lung Cancer Assay, as it is already approved by China’s NMPA
and is being commercialized in China. This product is based on the
Company’s proprietary One-Step Seq Method, offering fast and
easy-to-use testing procedures, that is suitable for independent
operation within hospitals. With the One-Step Seq technology, the
library construction process is finished in one step of reaction,
minimizing manual operation to one mixture of reagents with
DNA/cDNA. The chance of contamination in the process is minimal
with the “sample in library out” workflow. The assay is compatible
with the Genetron S5 sequencing platform, and together they offer a
two-day turnaround time from sample to report. The 8-gene Lung
Cancer Assay covers mutations of EGFR, BRAF, KRAS, HER2 and PIK3CA,
translocations of ALK and ROS1, and MET exon 14 skipping, and 7 of
these genes are recommended biomarkers by the 2018 NCCN guideline
for Non-Small Cell Lung Cancer (NSCLC) patients. Several targeted
therapy drugs such as Gefitinib, Osimertinib, Crizotinib and
Savolitinib have been approved by the NMPA for treatments of NSCLC
patients with those genomic alterations.
“We are excited to receive the CE Mark, which represents an
important new commercialization opportunity for our 8-gene Lung
Cancer Assay. Together with our Genetron S5 and fully automated
bioinformatics solutions, we offer an end-to-end, fast turnaround
and seamless workflow for hospitals and clinical laboratories that
prefer to run NGS testing on their own. We believe that this offers
a significant operational advantage for our customers outside China
and we have received very positive feedback since launching in
China,” said Sizhen Wang, Co-founder and CEO of Genetron
Health.
Separately, the Company also reported comparative performance
data of its SARS-CoV-2 RNA Test based on a SARS-CoV-2 reference
panel established by the U.S. Food and Drug Administration (FDA).
The goal of the reference panel is to allow for a more precise
comparison of the analytical performance of different molecular in
vitro diagnostic (IVD) assays intended to detect SARS-CoV-2.
Results from the blind testing of this panel showed that the
sensitivity or limit of detection (LoD) of Genetron’s SARS-CoV-2
RNA Test was 1,800 NDU/mL, which was the best among all domestic
companies in China in the same category, and also fared well
compared to global companies. Background information, and peer
data, regarding this FDA reference panel initiative can be found on
the FDA website.
In June 2020, Genetron Health received Emergency Use
Authorization (EUA) from the FDA for its independently developed
SARS-CoV-2 RNA Test for the novel coronavirus. Additionally, the
kit received approval for export from the relevant authorities in
China (Press Release).
Mr. Wang continued, “We have supplied this test to various
high-risk geographies around the world since the beginning of the
pandemic. This FDA initiative allows us to fairly compare our
product with other manufacturers, and we are pleased that we have
achieved the best performance among the domestic companies, which
further demonstrates our company’s capability and commitment to
providing high-quality molecular diagnostic solutions.”
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 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 research results
and genomic research, Company’s One-Step Seq Method, studies on
optimizing clinical routine diagnosis methods 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 ContactUS:Hoki LukHead of
Investor RelationsEmail: hoki.luk@genetronhealth.comPhone: +1
(408) 891-9255
David Deuchler, CFAManaging Director | Gilmartin
Groupir@genetronhealth.com
Media Relations ContactYanrong ZhaoGenetron
Healthyanrong.zhao@genetronhealth.com
Edmond LococoICREdmond.Lococo@icrinc.comMobile: +86
138-1079-1408genetron.pr@icrinc.com
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