QIAGEN Launches First FDA-approved Tissue Companion Diagnostic to Identify the KRAS G12C Mutation in NSCLC Tumours & Expand P...
May 28 2021 - 1:45PM
Business Wire
- The therascreen® KRAS RGQ PCR Kit receives U.S. regulatory
approval from FDA for expanded scope to include use in guiding
treatment with the newly approved therapy LUMAKRASTM (sotorasib)
from Amgen
- First tissue-based companion diagnostic to identify the KRAS
G12C mutation in NSCLC
- Test will be available under QIAGEN’s Day One Lab Readiness
program
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced the launch of an expanded scope of companion diagnostic
(CDx) claims for the therascreen® KRAS RGQ PCR Kit (therascreen
KRAS Kit) after it received U.S. regulatory approval as a companion
diagnostic to aid in the identification of non-small cell lung
cancer (NSCLC) patients that may be eligible for treatment with
LUMAKRASTM (sotorasib), a newly approved therapy developed and
marketed by Amgen Inc. (AMGN).
The therascreen KRAS Kit is the first companion diagnostic test
to obtain premarket approval from the U.S. Food and Drug
Administration (FDA) for use to identify the KRAS G12C mutation in
samples of NSCLC tumour tissue. KRAS is one of the most frequently
occurring mutation in this form of cancer, and is estimated to be
present in up to 13% of cases of the disease. Until now KRAS G12C
has not been actionable, and in fact had only previously been
linked with resistance to therapies. The real-time qualitative PCR
kit is used with the Rotor-Gene Q MDx instrument, a member of the
modular QIAsymphony family of automation solutions, and builds upon
QIAGEN’s nine years of experience in KRAS CDx test development and
commercialization.
“We are pleased to announce this significant expansion in the
scope of FDA-approved CDx claims for the therascreen KRAS Kit” said
Jean-Pascal Viola, Senior Vice President and Head of QIAGEN’s
Molecular Diagnostics Business Area. “This new approval further
expands our market-leading therascreen portfolio of companion
diagnostic tests, and illustrates our determination to support the
delivery of the latest innovations in precision healthcare to
patients with NSCLC, for whom every new treatment option is
extremely welcome.”
“With advances in precision medicine, biomarker testing is
critical for patients with non-small cell lung cancer because it
informs treatment options during the course of their disease. It is
important that patients and their healthcare providers know that
KRAS G12C is now an actionable mutation and start testing for it,”
said Darryl Sleep, M.D., chief medical officer and senior vice
president of Global Medical at Amgen. “With the approval of
QIAGEN’s companion diagnostic for LUMAKRAS, patients and clinicians
will have more options and flexibility for biomarker testing.”
Up to 13% of NSCLC-patients may have KRAS G12C positive tumours
and hence be potentially eligible for treatment with LUMAKRASTM. To
accelerate identification of these patients, following the FDA
approval of this test QIAGEN is making testing of NSCLC tumour
tissue samples with the therascreen KRAS Kit available immediately
at leading laboratories across the U.S, through QIAGEN’s Day-One
Lab Readiness program for Precision Medicine.
QIAGEN’s therascreen KRAS Kit was used to support the CodeBreaK
100 clinical trial of sotorasib and the expansion of the Kit’s CDx
claims to include identification of the KRAS G12C mutation in NSCLC
samples has been co-approved with LUMAKRAS by the FDA. The Amgen
drug is a new inhibitor of the G12C-mutated form of the KRAS
(Kirsten rat sarcoma) protein, and is the first-in-class drug
approved for treatment of this form of cancer. Further details
about the Kit are available at www.qiagen.com/KRAS.
QIAGEN’s Day-One Lab Readiness program builds on the FDA’s
modernized regulatory approach to benefit patients by accelerating
the launch of advanced diagnostics. An updated list of U.S.
laboratories offering testing of NSCLC samples for the KRAS G12C
mutation using the therascreen KRAS test is available at
www.qiagen.com/KRAS-lab-finder.
QIAGEN is a pioneer in Precision Medicine and the global leader
in collaborations with pharmaceutical and biotechnology companies
to co-develop companion diagnostics, which detect clinically
relevant genetic abnormalities to provide insights that guide
clinical decision-making in diseases such as cancer. QIAGEN has an
unmatched depth and breadth of technologies from next-generation
sequencing (NGS) to polymerase chain reaction (PCR) for companion
diagnostic development. QIAGEN now has ten PCR based companion
diagnostic indications that are FDA approved, including therascreen
EGFR for non-small cell lung cancer, therascreen KRAS for
colorectal cancer, therascreen FGFR for urothelial cancer,
therascreen PIK3CA for breast cancer based on tissue or plasma
samples and the therascreen BRAF kit for colorectal cancer.
Currently, QIAGEN is working under master collaboration
agreements with more than 25 companies to develop and commercialize
companion diagnostic tests for their drug candidates – a deep
pipeline of potential future products to advance Precision Medicine
for the benefit of patients. The therascreen KRAS Kit co-approval
with LUMAKRASTM marks the tenth FDA approval of a therapy partnered
with a QIAGEN companion diagnostic assay.
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),
Applied Testing (primarily forensics), Pharma (pharma and biotech
companies) and Academia (life sciences research). As of March 31,
2020, QIAGEN employed approximately 5,700 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, 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. 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 (SEC).
###
Category: Corporate
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QIAGEN Investor Relations John Gilardi +49 2103 29
11711 Phoebe Loh +49 2103 29 11457 e-mail: ir@QIAGEN.com Public
Relations Thomas Theuringer +49 2103 29 11826 Robert Reitze +49
2103 29 11676 e-mail: pr@QIAGEN.com
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