Skyline Diagnostics launches unique test to detect patients with AML

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 costly.

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.