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Cancer Genetics Gains CLIA, NYS Approvals to Offer Follicular, Mantle-Cell Lyphoma Tests

NEW YORK (GenomeWeb) – Cancer Genetics today said that it has received CLIA and New York State approvals to offer its mature B-cell neoplasm array for follicular lymphoma (MatBA-FL) and mantle-cell lymphoma (MatBA-MCL) as laboratory-developed tests.

Both tests were developed and validated in collaboration with Memorial Sloan Kettering Cancer Center. MatBA-FL identifies genomic aberrations that are associated with the high frequency of transformation of follicular lymphoma into diffuse large B-cell lymphoma and shorter overall survival, while MatBA-MCL identifies genomic aberrations that are associated with high frequency of leukemic involvement and/or shorter overall survival, Cancer Genetics said.

Having a clearer picture of a patient's outcome will help clinicians make more appropriate treatment decisions and better manage patients, as well as decide which patients may be appropriate to include in clinical trials, the company said.

Follicular lymphoma and mantle-cell lymphoma are subtypes of non-Hodgkin lymphoma (NHL). Follicular lymphoma is the most common slow-growing form of NHL, accounting for between 25 and 30 percent of all NHLs, Cancer Genetics said. Mantle-cell lymphoma is a rare B-cell cancer that mainly affects men over the age of 60 and accounts for about 5 percent of all NHLs.

In February 2013, Cancer Genetics, based in Rutherford, NJ, received CLIA and New York State approval to offer its MatBA-DLBCL test for diffuse large B-cell lymphoma.

Cancer Genetics' MatBA platform detects chromosomal gains and losses at more than 80 genomic sites associated with mature B-cell neoplasms. It is used in clinical laboratories for specimen types that include peripheral blood, bone marrow, cell suspension, and formalin-fixed, paraffin-embedded tissue.