Agendia Publishes Compelling First Independent Validation Study of Colon Cancer Recurrence Test "ColoPrint" in Journal of Clinical Oncology

By Agendia B.v., PRNE
Tuesday, December 14, 2010

Second Independent Validation Study of ColoPrint Selected for Oral Presentation and Press Conference at ASCO GI in January 2011

IRVINE, California and AMSTERDAM, December 15, 2010 - Agendia, a world leader in molecular cancer diagnostics,
announced today that together with principal investigators from Spain, the
UK, and the Netherlands, it has published the first independent validation
study of its colon cancer recurrence test "ColoPrint" in the Journal of
Clinical Oncology. The authors conclude that ColoPrint significantly improves
prognostic accuracy over assessment solely based on pathologic factors and
microsatellite instability in patients with stage II and III colorectal
cancer. In combination with classical pathological criteria, ColoPrint
facilitates the identification of stage II patients who may be safely managed
without chemotherapy.

About the study

This study aimed to develop a robust gene expression
classifier that can predict disease relapse in patients with early-stage
colorectal cancer (CRC). ColoPrint was developed using an unbiased analysis
of the entire human genome to identify recurrence-related genes. Frozen tumor
tissue from 188 untreated patients with stage I to IV CRC was analyzed using
Agilent 44K oligonucleotide arrays. A nearest mean classifier was developed
using a cross-validation procedure and an optimal set of 18 genes was
identified. The signature was validated on an independent set of 206 samples
from patients with stage I, II, and III CRC.

In the subset of patients with stage II disease, ColoPrint
correctly identified most patients (63%) as low risk. Low risk patients had a
chance of 90.9% to remain relapse free for 5 years while high risk patients
had only a 73.9% 5-year relapse-free survival (RFS). In stage II patients,
ColoPrint was the strongest predictor for RFS in the univariate analysis (HR,
3.34; 95% CI, 1.24 to 9.00; P 0.017) and multivariate analysis. The
classifier performed independently from the ASCO risk criteria when analyzed
either individually or combined (HR, 3.66; 95% CI, 1.24 to 9.08; P 0.017).
Furthermore, in the analysis of all samples and of samples from patients with
stage III disease only, ColoPrint remained a strong independent prognostic

The study's lead author is Ramon Salazar, MD, from the
Institut Catala` d'Oncologia-IDIBELL, L'Hospitalet de Llobregat, in
Barcelona, Spain. The co-authors are from Agendia; the Netherlands Cancer
Institute and Slotervaart Hospital in Amsterdam, the Netherlands; Leiden
University Medical Center in Leiden, the Netherlands; and the University of
, Radcliffe Infirmary, in Oxford, United Kingdom.

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About ASCO GI (Jan 20-22, 2011, San Francisco, CA, US)

The results of a second independent validation study by
principal investigators from the university hospital Klinikum rechts der
, in Munich, Germany, have been submitted to the upcoming
Gastrointestinal Cancers Symposium organized by the American Society of
Clinical Oncology (ASCO). The lead author of the study, Dr. Robert Rosenberg,
has been invited to give an oral presentation at ASCO GI and, additionally,
to present his data at a press conference for specialized media.

About ColoPrint(R)

ColoPrint(R) is a novel gene expression profile that
identifies Stage II or III colorectal cancer patients who are either at low
risk or at high risk of experiencing a disease relapse. In combination with
clinical parameters, ColoPrint can provide clinicians with a reliable means
to assist them in adjuvant treatment decision-making. The development of
ColoPrint follows the successful development and widespread clinical use of
MammaPrint, the first and only FDA-cleared breast cancer recurrence assay.
ColoPrint and MammaPrint have been developed by Agendia.

About Agendia

Agendia is at the forefront of the personalized medicine
revolution, striving to bring more effective, individualized treatments
within reach of patients. Building on a cutting-edge genomics platform for
tumor gene expression profiling, the company's tests help physicians more
accurately tailor cancer treatments. Agendia markets four products, with
several new genomic tests under development. In addition, Agendia
collaborates with pharmaceutical companies to develop highly effective
personalized drugs in the area of oncology. Agendia is based in Irvine,
, and in Amsterdam, the Netherlands.

Hans Herklots, +31-20-462-1557 Office, +31-620-083-509 Mobile, hans.herklots at, Valerie Carter, Ricochet Public Relations, +1-202-316-0143 Mobile, vcarter at

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