International Expert Panel Recommends Use of Multigene Profiling Assays and Finds Intermediate Scores Lack Clinical Utility

HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, June 23, 2009 – Agendia, a world leader in molecular cancer diagnostics, today announced the inclusion of its breast cancer recurrence test MammaPrint in St. Gallen’s ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, May 28, 2009 – Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech’s Citizen’s Petition. Filed on December 5, 2008, Docket No. FDA-2008-P-0638-0001/CP petitions that all in vitro diagnostic tests be held to one set of scientific ...
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Dr. Bernhard Sixt
President & Chief Executive Officer
Agendia BV
Science Park 406
1098 XH Amsterdam
The Netherlands

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
USA

28 May, 2009
Re: Docket No. FDA-2008-P-0638-0001/CP

Dear Sir ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, May 26, 2009 – Agendia, a world leader in molecular cancer diagnostics, today announced the opening of its U.S. clinical genomics laboratory in Huntington Beach, CA. The laboratory is fully-licensed and compliant with the Clinical Laboratory Improvements Amendments (CLIA) as administered by the ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, May 21, 2009 -- Agendia, a world leader in molecular cancer diagnostics, today announced that leading researchers from Agendia, the University of California San Francisco and the Netherlands Cancer Institute will present data from multiple studies at the American Society of Clinical Oncology ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, March 24, 2009 -- Agendia, a world leader in molecular cancer diagnostics, today announced that the Company is scheduled to present at the 16th Anniversary "Future Leaders in the Biotech Industry" Conference on Thursday, April 2, 2009. Presented by BioCentury and Thomson Reuters, ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, March 11, 2009 -- Agendia, a world leader in molecular cancer diagnostics, today announced that leading researchers from Agendia and the Netherlands Cancer Institute will present data from multiple studies at the 2009 St.Gallen Breast Cancer Conference.  The St. Gallen Breast Cancer Conference, ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, March 5, 2009 – Agendia, a world leader in molecular cancer diagnostics, today announced the appointment of Dr. Albert A. (Al) Luderer to its Supervisory Board.

Dr. Luderer has more than 30 years of experience in in vitro medical diagnostics, laboratory medicine ...
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Findings published in peer-reviewed journal, Breast Cancer Research and Treatment

HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, February 18, 2009 -- Agendia, a world leader in molecular cancer diagnostics, today announced that a study demonstrating the direct predictive ability of its breast cancer recurrence test, MammaPrint®, has been published ...
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Strategic Position Created to Increase Pharmaceutical & Biotechnology Partnerships

HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, February 11, 2009 – Agendia, a world leader in molecular cancer diagnostics, today announced the appointment of Alan B. Carter as the company’s new Vice President of Global Business Development.

“As ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, February 4, 2009 -- Agendia, a world leader in molecular cancer diagnostics, today announced that its signature breast cancer test MammaPrint® will be offered as standard of care for all eligible early stage breast cancer patients at the Netherlands Cancer Institute-Antoni van Leeuwenhoek ...
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Recent Study Reveals Substantial Group of Traditionally Miscategorized HER2+ Patients

HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, December 13, 2008 – Dr. Michael Knauer from the Netherlands Cancer Institute today announced data uncovering a substantial group of traditionally miscategorized low risk HER2+ patients.  Agendia’s highly accurate breast cancer tumor ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, December 12, 2008 -- Agendia, a world leader in molecular cancer diagnostics, today announced MammaPrint®’s ability to predict response to neoadjuvant chemotherapy in breast cancer.

Dr. Laura van ‘t Veer, from the Netherlands Cancer Institute,  presented the data at the 2008 San ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, December 8, 2008 -- Agendia, a world leader in molecular cancer diagnostics, today announced that leading Agendia and the Netherlands Cancer Institute researchers will present data from multiple studies at the 2008 San Antonio Breast Cancer Symposium (SABCS) and Agendia will support, with ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, September 18, 2008 -- Agendia, a world leader in molecular cancer diagnostics, today announced that its signature breast cancer tumor recurrence test, MammaPrint®, has been included in the updated 2008 guidelines of The Dutch Institute for Healthcare Improvement CBO. The CBO guidelines, which ...
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HUNTINGTON BEACH, CA, and AMSTERDAM, The Netherlands, September 4, 2008 / Agendia, a world leader in molecular cancer diagnostics, today announced the launch of TargetPrint®, a new diagnostic test that allows physicians to quantitatively determine the gene expression levels of the estrogen receptor (ER), progesterone receptor (PR) and Human ...
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AMSTERDAM, The Netherlands and BARCELONA, Spain, July 15, 2008 / Agendia BV and Ferrer inCode today announced an agreement that will give Ferrer exclusive rights to sell two of Agendia’s signature cancer diagnostic services.

MammaPrint, a prognostic test that uses a 70-gene signature to indicate risk of breast cancer tumor recurrence, ...
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AMSTERDAM, The Netherlands, June 19, 2008 / Agendia BV has announced the official opening of the company's new headquarters yesterday at Amsterdam's Science Park at Watergraafsmeer, Kruislaan 406. The Grand Opening ceremony was officiated by Dr. Rene Bernards, Chief Scientific Officer at Agendia and the Honourable Director General Mrs. ...
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CHIGACO, USA, May 30, 2008 / Agendia BV, a world leader in the rapidly evolving field of molecular diagnostics, announced today that data from two studies involving its MammaPrint breast cancer prognosis test will be presented at the American Society of Clinical Oncology’s (ASCO) annual meeting. Collectively, these findings ...
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AMSTERDAM, The Netherlands, February 19, 2008 / Agendia BV, Breast cancer is the most common cancer in women worldwide. If breast cancer is diagnosed at an early stage, the survival rate is currently over 70 percent. However, about 30 percent of stage I and II breast cancer patients develop metastases ...
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