QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
the U.S. Food and Drug Administration (FDA) approval of its
therascreen PDGFRA RGQ PCR kit (therascreen PDGFRA kit).
This companion diagnostic is intended for use to
aid clinicians in identifying patients with gastrointestinal
stromal tumors (GIST) who may be eligible for treatment with
AYVAKIT® (avapritinib), which is approved in the U.S. for the
treatment of adults with unresectable or metastatic GIST harboring
a platelet-derived growth factor receptor alpha (PDGFRA) exon 18
mutation, including PDGFRA D842V mutations[1]. The kit is the first
platelet-derived growth factor receptor alpha (PDGFRA) assay to
receive FDA approval as a companion diagnostic.
QIAGEN and Blueprint Medicines collaboratively
developed the PDGFRA companion diagnostic assay. The real-time
qualitative PCR in vitro diagnostic assay detects the D842V somatic
mutation in the PDGFRA gene to determine which patients may be a
candidate for treatment with AYVAKIT. The tyrosine kinase inhibitor
(TKI) is designed to target the PDGFRA exon 18 D842V mutation and
was approved by the FDA in 2020. GIST patients harboring the D842V
mutation in PDGFRA exon 18 show primary resistance to previously
approved TKIs.
The therascreen PDGFRA kit uses genomic DNA
extracted from a patient’s formalin-fixed paraffin-embedded (FFPE)
tumor tissue. FFPE tumor specimens are processed using the QIAamp
DSP DNA FFPE Tissue Kit for sample preparation and the Rotor-Gene Q
(RGQ) MDx instrument for DNA amplification and mutation
detection.
“The therascreen PDGFRA kit is an FDA approved
and validated test, delivering results in a fast turnaround time.
This ensures that physicians receive results promptly, enabling
them to make informed treatment decisions for their GIST patients
in a timely and effective manner,” said Jonathan Arnold, Vice
President, Head of Translational Science and Precision Diagnostics
at QIAGEN. “This latest approval confirms QIAGEN’s leadership in
companion diagnostics development. It adds to QIAGEN’s extensive
list of now 12 FDA-approved companion diagnostics.”
GIST is a rare, genomically driven sarcoma of
the gastrointestinal tract. Approximately six percent of patients
with newly diagnosed GIST have PDGFRA exon 18 mutations, the most
common of which is the D842V mutation[2]. Since the introduction of
TKIs, including AYVAKIT, the treatment of GIST patients with
locally advanced and metastatic disease has dramatically
improved[3].
QIAGEN is a pioneer in precision medicine and
the leader in collaborating with pharmaceutical and biotechnology
companies to develop companion diagnostics. These can detect
genetic abnormalities to provide insights that guide clinical
decision-making about treatments. From polymerase chain reaction
(PCR) and digital PCR (dPCR) to next-generation sequencing (NGS),
QIAGEN offers an unmatched breadth of technologies, which means it
can tailor products to partners’ needs.
QIAGEN has master collaboration agreements to
develop and commercialize companion diagnostics with more than 30
global companies – a deep pipeline that will advance so-called
precision medicine, which tailors a patient’s treatment to the
genetic profile identified by companion diagnostics testing.
Furthermore, QIAGEN has recently announced a series of
collaborations with Neuron23 and Helix to develop companion
diagnostics in disease areas outside oncology.
AYVAKIT® is a registered trademark of Blueprint
Medicines. Full prescribing information for AYVAKIT can be found
here.
About QIAGEN
QIAGEN N.V., a Netherlands-based holding
company, is the leading global provider of Sample to Insight
solutions that enable customers to gain valuable molecular insights
from samples containing the building blocks of life. Our sample
technologies isolate and process DNA, RNA and proteins from blood,
tissue and other materials. Assay technologies make these
biomolecules visible and ready for analysis. Bioinformatics
software and knowledge bases interpret data to report relevant,
actionable insights. Automation solutions tie these together in
seamless and cost-effective workflows. QIAGEN provides solutions to
more than 500,000 customers around the world in Molecular
Diagnostics (human healthcare) and Life Sciences (academia, pharma
R&D and industrial applications, primarily forensics). As of
March 31, 2023, QIAGEN employed more than 6,200 people in over
35 locations worldwide. Further information can be found at
http://www.qiagen.com.
Forward-Looking Statement
Certain statements contained in this press
release may be considered forward-looking statements within the
meaning of Section 27A of the U.S. Securities Act of 1933, as
amended, and Section 21E of the U.S. Securities Exchange Act of
1934, as amended. To the extent that any of the statements
contained herein relating to QIAGEN's products, including those
products used in the response to the COVID-19 pandemic, timing for
launch and development, marketing and/or regulatory approvals,
financial and operational outlook, growth and expansion,
collaborations, markets, strategy or operating results, including
without limitation its expected adjusted net sales and adjusted
diluted earnings results, are forward-looking, such statements are
based on current expectations and assumptions that involve a number
of uncertainties and risks. Such uncertainties and risks include,
but are not limited to, risks associated with management of growth
and international operations (including the effects of currency
fluctuations, regulatory processes and dependence on logistics),
variability of operating results and allocations between customer
classes, the commercial development of markets for our products to
customers in academia, pharma, applied testing and molecular
diagnostics; changing relationships with customers, suppliers and
strategic partners; competition; rapid or unexpected changes in
technologies; fluctuations in demand for QIAGEN's products
(including fluctuations due to general economic conditions, the
level and timing of customers' funding, budgets and other factors);
our ability to obtain regulatory approval of our products;
difficulties in successfully adapting QIAGEN's products to
integrated solutions and producing such products; the ability of
QIAGEN to identify and develop new products and to differentiate
and protect our products from competitors' products; market
acceptance of QIAGEN's new products and the integration of acquired
technologies and businesses; actions of governments, global or
regional economic developments, weather or transportation delays,
natural disasters, political or public health crises, including the
breadth and duration of the COVID-19 pandemic and its impact on the
demand for our products and other aspects of our business, or other
force majeure events; as well as the possibility that expected
benefits related to recent or pending acquisitions may not
materialize as expected; and the other factors discussed under the
heading “Risk Factors” contained in Item 3 of our most recent
Annual Report on Form 20-F. For further information, please refer
to the discussions in reports that QIAGEN has filed with, or
furnished to, the U.S. Securities and Exchange Commission.
Source: QIAGEN N.VCategory: Corporate
[1] AYVAKIT™ (avapritinib) Prescribing Information (U.S.).
Blueprint Medicines Corporation, Cambridge, Massachusetts, USA[2]
Corless CL, Antonescu, C., Gastrointestinal stromal tumors: what do
we know now? Modern Pathology: 2014. 27:1.
https://doi.org/10.1038/modpathol.2013.173[3] Blay, JY., Kang, YK.,
Nishida, T. et al., Gastrointestinal stromal
tumours. Nat Rev Dis Primers 7, 22 (2021).
https://doi.org/10.1038/s41572-021-00254-5
John Gilardi
QIAGEN N.V.
+49 2103 29 11711
pr@qiagen.com
Phoebe Loh
QIAGEN N.V.
+49 2103 29 11457
ir@qiagen.com
Thomas Theuringer
QIAGEN N.V.
+49 2103 29 11826
pr@qiagen.com
Daniela Eltrop
QIAGEN N.V.
+49 2103 29 11676
pr@qiagen.com
Qiagen NV (NYSE:QGEN)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Qiagen NV (NYSE:QGEN)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024