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Cancer Genetics Gains CLIA, New York Approval for Diffuse Large B-cell Lymphoma Assay

NEW YORK (GenomeWeb News) – Cancer Genetics has received CLIA and New York State approvals for the clinical use of its mature B-cell neoplasm array, or MatBA, for diffuse large B-cell lymphoma, the company said late Monday.

The MatBA-DLBCL array is to assist clinicians in the diagnosis and prognosis of DLBCL.

The array is part of the DLBCL Complete program from Cancer Genetics which includes esoteric tests for DLBCL. The disease is the most common form of non-Hodgkin lymphoma with an estimated 190,000 people in the US diagnosed with the disease, accounting for up to 40 percent of non-Hodgkin lymphoma cases, the firm said.

Rutherford, N.J.-based Cancer Genetics said that being able to choose the right treatment option at diagnosis and during monitoring "is highly desirable considering that the median age at diagnosis is 64 years and that patients display clinical heterogeneity in the course of their disease."

Prognostication, it added is based mostly on clinical features, but array-based comparative genomic hybridization has been able to identify genomic alterations in DLBCL, revealing gains and losses associated with treatment outcomes.

Cancer Genetics is currently waiting to complete its initial public offering and two weeks ago lowered the expected proceeds from the offering to $23.5 million.