CombiMatrix Molecular Diagnostics Launches HemeScan MDS for the Management and Diagnosis of Myelodysplastic Syndromes
Tuesday September 25, 9:00 am ET
MUKILTEO, Wash., Sept. 25, 2007 (PRIME NEWSWIRE) -- CombiMatrix Corporation (NasdaqCM:CBMX - News) announced today that its subsidiary, CombiMatrix Molecular Diagnostics (or ``CMDX''), has completed the clinical validation of the third of its HemeScan(tm) suite of Bacterial Artificial Chromosome (or ``BAC'') Comparative Genomic Hybridization (or ``CGH'') array-based tests. HemeScan(tm) MDS (myelodysplastic syndromes) is designed to detect clonal prognostic markers in bone marrow aspirates from patients with refractory anemia combining diagnosis of pre-leukemia with individualized risk stratification and treatment planning. It is now available to the clinical community through both routine clinical sample processing as well as through CMDX's innovative Technical Only Program for reference laboratories. The HemeScan tests are the industry's first clinically validated cancer diagnostics based on BAC array CGH technology.
Several thousand cases of MDS, a group of diseases caused by abnormal bone marrow cells, are diagnosed each year in the United States. Most cases occur in older adults, but MDS can be seen in people of all ages including children who have received chemotherapy or radiation therapy for other malignancies. Affected individuals are at risk for bleeding and infection due to bone marrow failure and approximately 40% of MDS patients will transform to acute leukemia within a few months to years after diagnosis. To identify those at high risk for leukemic transformation, patients are given an individualized prognosis based on the International Prognostic Scoring System (or ``IPSS''). The IPSS score risk-stratifies patients into ``good'', ``intermediate'' and ``poor'' categories based on blood cell counts and chromosome abnormalities. HemeScan(tm) MDS is designed to detect chromosome imbalances included in the IPSS scoring system while simultaneously giving clinicians a genome-wide analysis of the abnormal cells.
Recent studies have shown that identification of chromosome abnormalities and categorization of patients into IPSS risk-stratification groups improves treatment planning and patient management. Although traditional treatment for MDS has been supported care in which disease symptoms but not the underlying disease was addressed, it is now recognized that many patients benefit from aggressive treatment, including bone marrow transplant and new chemotherapeutic agents. These drugs include differentiating agents which help immature blood cells to mature and immunomodulatory agents which help regulate abnormal immune functions. Several drugs are specifically targeted to patients with low or intermediate risk MDS associated with del(5q), while others are reserved for patients with high risk disease due the possibility of serious side effects.
``HemeScan is designed to quickly give clinicians an overview of the genome and identify the specific chromosome abnormalities used for grouping patients into specific IPSS prognostic groups'', said Dr. Shelly Gunn, Medical Director of CMDX. ``At the same time, HemeScan identifies global genomic abnormalities which are often used to establish the presence of an abnormal cell population in the bone marrow and thus a diagnosis of MDS. When used in conjunction with fluorescence in-situ hybridization for identification of clinically relevant balanced translocations, HemeScan provides an innovative alternative to time consuming, laborious, and often inadequate traditional cytogenetic methods for enumerating chromosomal content of a tumor genome,'' concluded Dr. Gunn.
``We are pleased with the performance of our HemeScan array in MDS'', said Dr. Mansoor Mohammed, President and CEO of CMDX. ``It is an important addition to our HemeScan suite of products designed to give hematopathologists the ability to provide clinicians and patients with information about prognosis at the time of diagnosis. Our HemeScan MDS test complements our recently introduced HemeScan Prognostic test for CLL, the most common leukemia in adults and our HemeScan Ploidy test for ALL, the most common leukemia in children. We look forward to adding additional hematology/oncology tests in the near future as we continue to leverage the information gleaned from the complete sequencing of the human genome through our partnership with the world renowned Centre for Applied Genomics in Toronto,'' concluded Dr. Mohammed |
