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 a research piece titled “Integrated analysis
of circulating tumor cells and circulating tumor DNA to detect
minimal residual disease in hepatocellular carcinoma” has been
published in a highly impactful journal, Clinical and Translational
Medicine (Impact Factor: 11.5). The Company’s Mutation Capsule™
technology was used in the publication and the full article can be
found here.
Recurrence is the major reason for mortality after hepatectomy
or liver transplantation surgery for HCC.1-4 It is difficult to
precisely manage adjuvant therapy to prevent recurrence after
surgery. Thanks to the multiplex profiling feature of Mutation
Capsule™ technology, a comprehensive cell-free DNA (cfDNA)
analysis was conducted enabling a head-to-head comparison of the
biomarkers and approaches for predicting recurrence, including
profiling both circulating tumor cells (CTCs) and circulating tumor
DNA (ctDNA) in the same blood samples. In the publication, 66
patients were eligible for analysis using postoperative serial
blood samples, and the ctDNA status was determined by three
strategies:
- Personalized assay targeting mutations from whole-exome
sequencing (WES) on tumor samples
- Universal panel targeted sequencing (UPTS) covering the most
frequent alterations in HCC, along with HBV integration
- Tumor-naïve fixed panel by profiling ctDNA without considering
the mutation status in tumor tissues
In predicting recurrence-free survival rates through
Kaplan-Meier analysis, UPTS showed strong performance (p <
.0001; HR 12.95, 95% CI = 5.08–33.03) comparable to personalized
assay (p < .0001; HR 11.77, 95% CI = 4.96–27.96) in the cases
with mutations or HBV integrations detected in tumor tissues. The
prediction power of the tumor-naïve assay was less than the
personalized assays (p < .0001; HR 6.77, 95% CI = 3.16–14.51).
Furthermore, the researchers explored the synergistic effect of
CTCs and ctDNA. The data showed that the performance of cfDNA based
tumor-naïve assays could be further improved by combining with
CTCs. These findings underscore the importance of CTC and ctDNA
integration in recurrence prediction and could also provide a
reference for selecting strategies for HCC MRD surveillance.
“MRD testing may help in the clinical management
for patients, well before metastatic lesions grow to significant
size detectable by conventional methods such as MRI and CT scan.
This publication adds to a growing body of clinical evidence of
Mutation Capsule™, highlighting its versatility in MRD assay
developments,” said Sizhen Wang, Chairman, Co-Founder and CEO of
Genetron Health. “Regarding our partnership with AstraZeneca
R&D China in developing personalized assays, assay optimization
is currently ongoing and a commercial launch is planned for this
year. Genetron is also evaluating different biomarkers for the
tumor-naïve MRD approach. We are excited that these programs could
not only expand our product offerings in the continuum of care for
cancer, but may also help more patients detect returning cancer
sooner than current methods.”
Recently published MRD assay data based on Genetron Health’s
Mutation Capsule™ also include:
- Gastric cancer data in the Journal
of Hematology & Oncology: the personalized MRD assay showed
excellent sensitivity to detect 0.001% tumor DNA from peritoneal
lavage fluid samples for precise prediction of peritoneal
dissemination.
- Locally advanced rectal cancer data
in eBioMedicine, part of THE LANCET Discovery Science: Analysis on
different MRD approaches after neoadjuvant therapy.
References1. Sung H, Ferlay J, Siegel RL, et
al. Global cancer statistics 2020: GLOBOCAN estimates of incidence
and mortality worldwide for 36 cancers in 185 countries. CA Cancer
J Clin. 2021;71(3):209-249.2. Reinert T, Henriksen TV, Christensen
E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing
in patients with stages I to III colorectal cancer. JAMA Oncol.
2019;5(8):1124-113.3. Cai Z, Chen G, Zeng Y. Comprehensive liquid
profiling of circulating tumor DNA and protein biomarkers in
long-term follow-up patients with hepatocellular carcinoma. Clin
Cancer Res. 2019;25(17):5284-5294.4. Cristofanilli M, Budd GT,
Ellis MJ, et al. Circulating tumor cells, disease progression, and
survival in metastatic breast cancer. N Engl J Med.
2004;351(8):781-791.
About Clinical and Translational
MedicineClinical and Translational Medicine is an
international, peer-reviewed, and open access journal with aims at
promoting and accelerating the translation of preclinical research
to a clinical application and the communication between basic and
clinical scientists. The journal emphasizes clinical potential and
application of new biotechnologies, biomaterials, bioengineering,
disease-specific biomarkers, cellular and molecular medicine, omics
science, bioinformatics, applied immunology, molecular imaging,
drug discovery and development, and regulation and health policy.
The journal is focused on the bench to bedside approach, favoring
studies and clinical observations which generate hypotheses and
questions relevant to the patient and disease, and guide the
investigations of cellular and molecular medicine. For more
information, please visit:
https://onlinelibrary.wiley.com/page/journal/20011326/homepage/productinformation.html
About Genetron’s MRD program in solid tumor and Mutation
Capsule™ technology
Genetron’s MRD program in solid tumor is powered by its Mutation
Capsule™ technology. This proprietary technology allows the
detection of methylation alterations and mutations in one reaction,
and thus requires less blood while achieving high detection
sensitivity. In addition, the cell-free DNA (cfDNA) sample’s
genetic and epigenetic information can be preserved and amplified
in the Mutation Capsule™ library, and can be used for multiple
analyses without sacrificing sensitivity. In MRD development, this
feature reduces panel validation time and provides head-to-head
comparisons between different MRD strategies, enabling significant
time and cost savings. Mutation Capsule™ also allows more
sensitive detection in low yield cfDNA samples, with higher
conversion efficiency of cfDNA molecules. The technology was
recently granted an invention patent (201910983038.8) by the China
National Intellectual Property Administration.
Co-Development Agreement with AstraZeneca R&D China
for Personalized MRD Tests for Solid Tumors in China
In November 2021, Genetron announced a collaboration agreement
with AstraZeneca R&D China for the joint development in China
of next-generation sequencing (NGS)-based tumor-informed
(personalized) minimal residual disease (MRD) tests for various
solid tumor types. Under the agreement, the companies will jointly
invest capital for this collaboration. For solid tumor clinical
trials in China that incorporate the use of NGS-based personalized
MRD tests, AstraZeneca plans to incorporate the co-developed MRD
test in China-specific studies, subject to fulfillment of
individual study criteria. Upon both companies' further agreement,
the scope of the agreement may also be expanded to include IVD
registration and commercialization. This is an exclusive,
multi-year collaboration agreement between both parties, with
exclusivity contingent on certain requirements.
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, the
research results and genomic research, and Company’s Mutation
Capsule™ technology 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
Philip Trip TaylorVice President | Gilmartin
Groupir@genetronhealth.com
Media Relations ContactYanrong ZhaoGenetron
Healthyanrong.zhao@genetronhealth.com
Edmond LococoICREdmond.Lococo@icrinc.comMobile: +86
138-1079-1408
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