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

Irvine, California and Amsterdam (ots/PRNewswire) -
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 factor.

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 Oxford, Radcliffe Infirmary, in Oxford, United Kingdom.

To access the article online go to: http://jco.ascopubs.org/conte
nt/early/2010/11/15/JCO.2010.30.1077.full.pdf+html

(Due to the length of this URL, it may be necessary to copy and
paste this hyperlink into your Internet browser's URL address field.
Remove the space if one exists.)

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 Isar,
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, California, and in
Amsterdam, the Netherlands.

ots Originaltext: Agendia B.V.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: Hans Herklots, +31-20-462-1557 Office, +31-620-083-509
Mobile,hans.herklots@agendia.com, Valerie Carter, Ricochet Public
Relations,+1-202-316-0143 Mobile, vcarter@ricochetpr.com