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 the release of two research results from its
Seq-MRD® and FusionScan Plus product studies at the Association for
Molecular Pathology 2021 annual meeting.
Seq-MRD® detects minimal residual disease (MRD)
in B-lymphoid malignancies, while FusionScan Plus can
simultaneously detect a wide range of gene mutations and fusions.
The two studies (#1064612, #1062999) verified the high sensitivity
and high specificity of the two products, providing important
insights for clinical diagnosis, medication guidance and monitoring
of cancer relapses.
“Genetron Health developed the Seq-MRD® and
FusionScan Plus based on our patented One-Step Seq Technology,
which offers significant operational advantages while delivering
performance comparable to that of traditional detection methods,”
said Dr. Yun-Fu Hu, Chief Medical Officer of Genetron Health.
“Seq-MRD® provides an effective way to detect recurrences earlier
and improves clinical efficacy in patients with B-lymphoid
malignancies. FusionScan Plus provides an effective reference for
clinical pathological classification and targeted therapy
strategies by detecting gene mutations and fusions.”
“The data from both of these studies further
strengthened our confidence in these products’ clinical
applications. Genetron Health has signed an exclusive agreement
with Jiangsu Fosun Pharma and is working with them to accelerate
the application of Seq-MRD® in China’s key hematology hospitals and
clinics. FusionScan Plus represents another future exciting product
for us to tailor more precise clinical treatment plans for
patients,” Dr. Yun-Fu Hu continued.
Seq-MRD®—— A Next
Generation Sequencing Assay for Detecting Residual Disease in
B-lymphoid Malignancies
After hematological cancer treatment, patients’
bodies may sometimes not respond to treatment, or drug-resistant
cancer cells may linger. Therefore, a considerable proportion of
patients may still relapse. The number of these residual cancer
cells are so small that they do not cause any recurring symptoms in
the body, and it is difficult to detect them through traditional
clinical methods. In order to accurately detect these residual
cancer cells in patients after treatment, Seq-MRD® scans for them
through high throughput sequencing of immunoglobulin gene
rearrangements. This product’s performance was validated by study
#1064612.
Genetron Health incorporated different types of
samples in this study, including bone marrow from 56 B-cell
malignancy patients, peripheral blood from 40 healthy donors,
multiple myeloma (MM) cell line RPMI8226, and B-acute lymphoblastic
leukemia (B-ALL) cell line NALM6. Test performance parameters
included accuracy, linearity, limit of detection (LOD),
repeatability, limit of blank (LOB), and others.
The study showed that high-throughput sequencing
of B-cell receptor (BCR) genes also exhibit higher sensitivity and
specificity in the detection of MRD in lymphoid malignancies.
FusionScan Plus— An Intergreted DNA and
RNA Next Generation Sequencing Assay for
Simultaneously Detecting Multiple Gene Mutations and
Fusions with Lower Thresholds
Drugs targeting gene fusions have been used in
clinical situations to treat cancer patients, and detecting gene
fusions and drug resistant mutations can help better predict
therapy effectiveness. High-throughput sequencing of integrated DNA
and RNA is an ideal method to screen for gene mutations and
fusions. However, current assays based on parallel detection of DNA
and RNA can only detect specific gene mutations and fusions, and
oftentimes need many different samples. Therefore, there is a
strong clinical need for an assay that can simultaneously detect a
wide range of gene mutations and fusions, and with lower threshold
requirements.
Genetron Health has developed a next generation
sequencing assay, FusionScan Plus, which uses integrated DNA and
RNA as a template for genetic alteration detection. Based on
Genetron Health’s One Step Seq Method, FusionScan Plus covers 23
tumor-related genes and 37 fusion genes without a priori knowledge
of 5' fusion partner. The study (#1062999) from examining 76
formalin-fixed paraffin-embedded (FFPE) tissue samples proved that
FusionScan Plus demonstrated high accuracy in the simultaneous
detection of gene mutations and fusions without a priori knowledge
of 5' fusion partner. It can be used to detect drug sites for
cancer patients, even with limited biopsy samples, and presents
promising insights for clinical applications.
About AMP
The Association for Molecular Pathology (AMP)
was founded in 1995 to provide structure and leadership to the
emerging field of molecular diagnostics. AMP's 2,500+ members
practice various disciplines of molecular diagnostics, including
bioinformatics, infectious diseases, inherited conditions, and
oncology. Its members are pathologists, clinical laboratory
directors, basic and translational scientists, technologists, and
trainees that practice in a variety of settings, including academic
and community medical centers, government, and industry. Through
the efforts of its Board of Directors, Committees, Working Groups,
and Members, AMP is the primary resource for expertise, education,
and collaboration in one of the fastest growing fields in
healthcare. AMP members influence policy and regulation on the
national and international levels, ultimately serving to advance
innovation in the field and protect patient access to high-quality,
appropriate testing. For more information, visit www.amp.org and
follow AMP on Twitter: @AMPath.
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 within the meaning of federal securities laws 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 Contact
Hoki LukEmail: hoki.luk@genetronhealth.comPhone:
+1 (408) 891-9255
Media Relations Contact
Yanrong Zhaoyanrong.zhao@genetronhealth.com
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