Dutch Firm Launches World's First Diagnostic Chip That Combines DNA Technologies to Rapidly Classify AML Patients

By Skyline Diagnostics B.v., PRNE
Tuesday, March 15, 2011

ROTTERDAM, The Netherlands, March 16, 2011 - Each year over eight million people die of cancer worldwide. Patients'
chances of survival vary widely: depending on the type of cancer involved,
the stage at which it is diagnosed and the speed with which appropriate
treatment is launched. Skyline Diagnostics B.V., a Dutch firm associated with
the Erasmus Medical Center in Rotterdam, has developed a unique diagnostic
test for patients with a particular form of blood cancer. The test combines
several DNA technologies into a single diagnostic chip, which determines a
patient's risk profile in just four days. This information is invaluable: it
forms the basis on which the doctor can fine-tune treatment, ultimately
increasing the patient's chances of survival.

First test launched on European market on March 15, 2011

Acute Myeloid Leukemia (AML) is the most lethal form of blood cancer,
responsible for over 9,000 deaths per year in the US alone. Its progress
varies widely in different patients. Research has revealed that the prognosis
for this disease can be established to a significant degree by measuring
specific aberrations in the patient's DNA. Based on the patient's individual
risk-profile, the physician can select the best method of treatment, often a
choice between chemotherapy and bone-marrow transplantation. A major choice,
since bone-marrow transplants can have fatal side-effects and are very

Skyline Diagnostics' first diagnostic test, the AMLprofiler(TM), has been
developed to rapidly classify individual AML patients into risk-categories.
Within four days, the AMLprofiler(TM) precisely identifies the sub-type of
AML, thus supporting the selection of the appropriate method of treatment.
Using DNA-chip technology, this new method can replace seven different tests
of which three are chromosomal aberrations, two gene-mutations and two
aberrant genetic activities. At present, these tests are often carried out
one by one, which takes more time and may result in incomplete availability
of important diagnostic information. By contrast, the AMLprofiler(TM)
delivers these test results in one assay within four days. This reduces the
patient's period of uncertainty and offers the physician more time to arrange
the most appropriate treatment.

On March 15, the AMLprofiler(TM) received CE-certification. With this
quality assurance the AMLprofiler(TM) can be sold on the European market.
Clinical studies are underway for certification by the US Food and Drug
Administration (FDA). With the use of the diagnostically approved Affymetrix
microarray platform and specially developed IT infrastructure, the
AMLprofiler(TM) is a cost-effective, standardized procedure for diagnosing
AML. This test is the world's first diagnostic DNA chip that makes it
possible to measure the activity of disease-related genes anywhere in the
world. In addition, it can be of great value for clinical research into new
cures for leukemia.

The development of the AMLprofiler(TM) has been supported by the Dutch
Center For Translational Molecular Medicine (CTMM) via its 'BioChip program'.
Skyline Diagnostics works closely with prominent scientists and has developed
strategic alliances with industrial partners for the global production and
distribution of its products.

De AMLprofiler(TM) is an example of how modern DNA technology makes
individualized medical treatment possible. In the near future, Skyline
Diagnostics will bring onto the market similar diagnostic tests for other
forms of cancer. The aim of this Rotterdam based company is to translate
scientific ideas and developments into practical diagnostic procedures.
Hopefully this will, in the future, contribute to transforming cancer from a
deadly to a chronic disease.

Website www.skyline-diagnostics.com

About CTMM

The Center for Translational Molecular Medicine (CTMM) is a Dutch
public-private partnership for the development of molecular technologies in
the field of diagnostics and imaging. Such technologies make early diagnosis
and patient-tailored treatment possible for oncologic, cardiovascular and
neurodegenerative conditions, as well as for diseases of the auto-immune
system. CTMM arranges fundraising, assessment and financing of
multi-disciplinary projects with active participation of companies and
university institutes established in The Netherlands. It is financed by the
Dutch government (50%), university institutes (25%) and the commercial sector

Basic CTMM statistics: 107 partners, 300 million euros in research
budgets, 21 projects running to the end of 2014.


Skyline Diagnostics B.V. Contact: Henk Vietor +31(0)10-703-84-10, E-mail info at skyline-diagnostics.com. For more information: Marjoke Kortas, +31(0)40-800-23-03, +31(0)6-29409770, marjoke.kortas at ctmm.nl

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