Biovica today announces that the company has submitted its CLIA lab application, marking yet another significant milestone for the US commercial launch of the recent FDA cleared test DiviTum®TKa. Biovica is now prepared to receive, analyze, and report results for its novel DiviTum®TKa diagnostic with capacity and capability to process samples nationwide.
“We are excited to make this submission for our CLIA lab certification for our new lab facility in San Diego, California. The submission for our CLIA application is a final, critical step to bringing this product into the US market and we look forward to launching DiviTum®TKa before year-end in USA,” said Warren Cresswell, President of the Americas at Biovica.
About DiviTum®TKa
DiviTum®TKa is an in vitro diagnostic device intended for the semi-quantitative measurement of thymidine kinase activity (TKa) in human serum. The assay is to be used as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients.
DiviTum®TKa determines the enzymatic activity of thymidine kinase (TK) in human serum samples through technology that enables the assay to measure TK activity with high sensitivity. Biovica is currently engaged in several clinical studies to generate high-quality clinical data on the performance of DiviTum®TKa within different solid tumor types and cell-cycle regulating drugs.