Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that it has received marketing clearance from the United States Food and Drug Administration (FDA) for its highly-sensitive in-situ hybridisation (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. This follows the test’s CE Mark approval in June of last year, further expanding its availability and use in clinical settings.
Test Description and Applications
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is a qualitative assay designed to assess more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide. This innovative test can evaluate small biopsies and formalin-fixed tissue, providing a comprehensive diagnostic tool for healthcare providers. Its high sensitivity and specificity allow for accurate differentiation between B-cell cancer and a normal, reactive immune response, offering diagnostic certainty and aiding in the development of targeted treatment plans.
Market and Clinical Impact
The FDA clearance of Roche’s VENTANA Kappa and Lambda Dual ISH test is a significant milestone in the field of oncology diagnostics. By providing a reliable and efficient method to differentiate B-cell lymphomas from other conditions, the test helps healthcare providers make more informed decisions, ultimately improving patient outcomes. This clearance further solidifies Roche’s position as a leader in diagnostic innovation, as it continues to develop and bring to market advanced tools for the diagnosis and management of complex diseases.-Fineline Info & Tech
