Worldwide more than eight million people die of cancer each year. The chance of survival depending on the type of cancer, the stage at which it is diagnosed and the speed with which appropriate treatment is launched. Skyline Diagnostics, a Dutch company 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, launched on European market on March 15, 2011, combines several DNA technologies into a single diagnostic chip, which determines a patient’s risk profile in just four days. The resulting information forms the basis on which the treating physician fine-tunes treatment, ultimately increasing the patient’s chances of survival.

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 costly.

Risk caregories
The diagnostic test, called AMLprofiler?, has been developed to rapidly classify individual AML patients into risk-categories. Within four days, the new test 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 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 received CE-certification. With this quality assurance the AMLprofiler 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 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.

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The development of the AMLprofiler has been supported by the ‘BioChip program’ from the Dutch 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.

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