PRESS RELEASE

Data adds to the growing body of evidence demonstrating the efficacy of Agendia’s MammaPrint® and BluePrint® testing to consistently inform optimal breast cancer treatment planning

 

IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – MAY 14, 2020 – Agendia, Inc., a world leader in precision oncology for breast cancer, announced today that they will present new data from its ongoing clinical research evaluating the MammaPrint® and BluePrint® genomic tests at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO), taking place virtually May 29-May 31, 2020.

Data will underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for patients throughout their treatment journey. This data builds upon existing clinical research that demonstrates the efficacy of Agendia’s MammaPrint and BluePrint testing to consistently inform optimal treatment planning.

Specific data selected for presentation will include: an evaluation of the concordance between human epidermal growth factor receptor 2 (HER2) status as put forth by the 2018 ASCO/CAP guideline classification and BluePrint genomic testing; an examination of specific oncogenes and their correlation with risk scoring and molecular subtyping results; the ability of a chemokine gene score and MammaPrint to predict pathologic complete response (pCR) following neoadjuvant chemotherapy.

Two other poster presentations will feature additional data sets from Agendia’s ongoing multicenter, prospective, observational trial for patients with Stage I, II, and III breast cancer (FLEX). Researchers will share data from FLEX analyses evaluating triple negative breast cancers (TNBC), as well as the clinical estrogen receptor status of Basal-Type tumors based on self-reported patient ethnicities, new gene expression profiles and investigator-initiated protocols in early stage breast cancer.

“Our MammaPrint and BluePrint assays have demonstrated the ability to uniquely guide the practice of precision oncology in helping patients and their healthcare providers create the most targeted and appropriate treatment plan,” says William Audeh, MD, MS, chief medical officer at Agendia. “We continue to investigate biologic drivers of breast cancer to help reduce uncertainty when choosing a treatment regimen and these latest data sets offer additional clinical insights that we believe can translate to improved patient outcomes.”

Following are details of the five Agendia abstracts that have been accepted for poster presentations at the 2020 ASCO Annual Congress:

  • TNBC subtype and clinical estrogen receptor status of genomically basal breast tumors in Caucasian, African American, and Latin American patients
    Authors: Kaklamani, V., et al.
    Session: Breast Cancer—Local/Regional/Adjuvant
    Abstract #: 556

  • The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer
    Authors: D’Abreo, N., et al.
    Session: Health Services Research and Quality Improvement
    Abstract #: TPS7088

  • High Risk breast cancer genes at 8q22-24 and their role in over 5000 patients evaluated with the 70-gene risk of recurrence assay
    Authors: Diab, S., et al.
    Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
    Abstract #: 3569

  • Adding precision to 2018 ASCO/CAP HER2 testing guidelines in breast cancer with genomic profiling
    Authors: Brufsky, A., et al.
    Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
    Abstract #: 3570

  • 12-chemokine gene expression score in breast cancer patients treated with
    neoadjuvant chemotherapy
    Authors: Soliman, H., et al.
    Session: Breast Cancer—Local/Regional/Adjuvant and Developmental Therapeutics—Immunotherapy
    Abstract #: 591

In addition, the European Organisation for Research and Treatment of Cancer (EORTC) will be presenting nearly nine year follow-up data from the landmark MINDACT study. The independent trial, originally published in the New England Journal of Medicine in 2016, confirmed the clinical utility of MammaPrint as a prognostic tool in identifying genomic Low Risk patients who do not significantly benefit from chemotherapy.

Please follow us on our Twitter, Facebook and LinkedIn pages for unique content we will be sharing throughout ASCO.

The ASCO 2020 virtual program can be found in our Resources section of our website.

About Agendia Agendia is a molecular diagnostics company committed to improving clinical outcomes and informing the journey for patients with early stage breast cancer. The company currently offers two commercially available genomic profiling tests, processed through its state-of-the-art facility in Irvine, California. Agendia also provides a next generation sequencing kit for use by local laboratories outside of the United States.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the first FDA-cleared risk-of-recurrence test backed by peer-reviewed, prospective outcome data and included in both national and international treatment guidelines. BluePrint, the 80-gene molecular subtyping assay, is a commercially available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint and BluePrint provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. By developing evidence-based, novel genomic tests, Agendia aims to support the evolving clinical needs of breast cancer patients and their physicians.

Agendia’s assays can be ordered on core biopsies or surgical specimens with results provided in as little as 5-7 days to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com

Media Contacts:

Dina Scaglione
Director, Marketing
Tel: 949.910.9401
Dina.scaglione@agendia.com

Terri Clevenger
Westwicke/ICR PR
Tel: 203.856.4326
terri.clevenger@icrinc.com