NeoGenomics Launches New Prognostic Molecular Panel for Chronic Lymphocytic Leukemia

NeoGenomics, Inc., a provider of cancer-focused genetic testing services, announced today that it has validated and launched the first molecular assay for clinical use in the United States that detects mutations in the SF3B1 gene (splicing factor 3b, subunit 1).

The test is offered as a stand-alone test, in conjunction with a new comprehensive prognostic profiling panel for patients with chronic lymphocytic leukemia (CLL). The CLL Profile panel also includes assays for IgVH mutation analysis, ZAP-70 expression measured by flow cytometry, and 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 mid-July.

Douglas VanOort, the company’s Chairman and CEO, commented, “This offering is part of NeoGenomics commitment to be on the leading edge of cancer genetics testing with a state-of-the-art menu of services. 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.”

Dr. Maher Albitar, the Company’s Chief Medical Officer and Director of Research and Development, commented, “Chronic lymphocytic leukemia can have significantly different severity depending on the genomic makeup of the leukemic cells. Many patients with the disease may go on with their life without needing any therapy, but in some patients the disease may progress rapidly. Our goal is to provide patients and their treating physicians with the most comprehensive prognostic indicators available so that treatment options and management can be well planned and precisely tailored for each individual patient”.