A molecular assay for clinical use is offered as a stand-alone test in the USA, in conjunction with a new comprehensive prognostic profiling panel for patients with chronic lymphocytic leukemia (CLL).
The stand alone test detects mutations in the splicing factor 3b, subunit 1 (SF3B1) gene. The CLL Profile panel also includes assays for IgVH mutation analysis, ZAP-70 expression measured by flow cytometry, and fluorescence in situ hybridization (FISH) tests targeting abnormalities of certain genes associated with CLL.
CLL accounts for about one-third of the 47,000 leukemia cases diagnosed in the US each year. SF3B1 mutations in CLL have been associated with aggressive disease. SF3B1 mutation analysis is also important for diagnosing and determining prognosis in patients with myelodysplastic syndrome (MDS). The NeoTYPE CLL Profile is the company’s first hematology profiling test panel. Five NeoTYPE profiles to characterize breast, gastric, colorectal, lung, and other solid tumors were previously launched in 2012.
NeoGenomics (Fort Myers, FL, USA) a provider of cancer-focused genetic testing services, launched the new prognostic molecular panel for CLL. The company is a high-complexity Clinical Laboratory Improvement Amendments (CLIA)-certified clinical laboratory that specializes in cancer genetics testing. NeoGenomics' testing services include cytogenetics, fluorescence in situ hybridization (FISH), flow cytometry, immunohistochemistry, morphology studies, anatomic pathology, and molecular genetic testing.
Douglas VanOort, the company’s chairman and CEO, commented, “Our new NeoTYPE Cancer Profile tests are designed to provide physicians with comprehensive information about the biology and potential clinical behavior of specific cancers so patients can be offered the best quality personalized management and therapies that are targeted to their specific cancers.”