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Roche Receives CE Mark for B-Cell Lymphoma Test

NEW YORK – Roche announced on Thursday that it has received CE marking for an in situ hybridization test to assess the full spectrum of B-cell lymphoma subtypes.

The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay helps differentiate B-cell cancer from a normal, reactive immune response, Roche said in a statement. The test can be used with small biopsies and formalin-fixed tissue and can assess more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide.

The assay qualitatively detects Kappa mRNA and Lambda mRNA in formalin-fixed, paraffin-embedded human bone marrow and lymphoid tissue stained on a BenchMark IHC/ISH instrument. The test's results should be interpreted by a pathologist in conjunction with histological examination, relevant clinical information, and proper controls, Roche noted.

"It’s important to be able to provide patients with a definitive diagnosis as symptoms of lymphoma can appear similar to the body’s normal reactive response to an infection," Roche Diagnostics CEO Matt Sause said in a statement. "This highly sensitive assay offers diagnostic certainty for patients with suspected B-cell lymphoma."

The test is being launched in countries accepting the CE mark.