Agendia Achieves CE-IVDR Certification for its MammaPrint® and BluePrint® Breast Cancer Assays
16 Agosto 2024 - 5:00AM
Business Wire
Agendia, Inc. today announced that it has obtained certification
from the European Union (EU) In Vitro Diagnostic Medical Device
Regulation (IVDR) for three products, including its MammaPrint®
FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint® and
BluePrint® NGS Kit. These products are classified as Class C under
this regulation. This certification recognizes Agendia’s strict
adherence to rigorous quality and safety standards and ensures the
tests’ reliability and effectiveness in clinical settings across
the EU.
“We are very proud to receive the IVDR certification for our
MammaPrint and BluePrint tests and look forward to continuing our
efforts in providing accurate and effective test results to those
undergoing breast cancer treatment,” said Mark R. Straley, Chief
Executive Officer of Agendia. “This achievement not only
underscores our commitment to delivering the highest standard of
care to patients, but also highlights our ability to meet the
stringent regulatory requirements necessary to address the needs of
breast cancer patients and clinicians around the world.”
The IVDR certification marks a significant advancement in
Agendia’s efforts to enhance the decision- making around treatment
pathways for those with early breast cancer. For more information
about the MammaPrint and BluePrint tests and Agendia’s ongoing
clinical trials, please visit: www.agendia.com
About Agendia
Agendia is a leading provider of innovative solutions in the
field of precision oncology. With a focus on early-stage breast
cancer, Agendia offers reliable biological insights that inform
personalized treatment decisions for patients and their care teams.
Their advanced genomic assays, MammaPrint® + BluePrint®, enable
clinicians to quickly identify the most effective treatment plan,
minimizing the risk of both under- and over-treatment. Both assays
have been approved for use in the clinical setting in the US and
the EU.
Founded in 2003 in Amsterdam, Agendia is headquartered in
Irvine, California with a state-of-the-art laboratory facility. Led
by world-renowned scientists and oncologists, Agendia is committed
to advancing genomic insights through ongoing research. This
includes the notable FLEX Study– the world's largest whole
transcriptome Real-World Evidence-based Breast Cancer database
which aims to revolutionize precision in breast cancer management.
With cutting-edge technology, research and innovation, Agendia
strives to shape the future of precision oncology and make a
significant impact in the fight against breast cancer.
About MammaPrint
MammaPrint® is a gene expression profiling test that reveals the
distinct underlying biology of an early-stage tumor to determine
its risk of spreading. As the only FDA-cleared gene expression
profiling test to assess a woman’s risk of distant metastasis,
MammaPrint provides critical answers that help inform the future of
her treatment plan at the point of diagnosis, including the timing
and benefit to chemotherapy and endocrine therapy. MammaPrint
listens to the signals from 70 key genes in a woman’s tumor to
stratify her risk within four distinct categories – ranging from
UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan
tailored to her biology and her life’s plans.
About BluePrint
BluePrint® is a gene expression profiling test that reveals the
driving forces behind a tumor’s growth at the earliest stage
possible in a woman’s breast cancer care journey to help optimize
and personalize treatment planning. As the only molecular subtyping
test available in the U.S., BluePrint goes where pathology cannot,
offers critical insights that providers may otherwise have not
known to act on, and gives women the best chance to return to a
life not defined by cancer. BluePrint measures the activity of 80
key genes that are involved in a tumor's growth to classify a tumor
as Luminal-type, HER2-type, or Basal-type, each of which warrant
distinct treatment pathways. By revealing the distinct underlying
biology of a woman's tumor, BluePrint can catch often
misclassified, yet highly aggressive, Basal tumors, so women can be
prescribed the most appropriate treatment from the start
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Media Terri Clevenger ICR
Westwicke Healthcare PR Tel: 203.682-8297
Terri.Clevenger@Westwicke.com