Biovica, active in cancer diagnostics, today announces that FDA has granted 510(k) clearance for the product DiviTum®TKa as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients.
“We are excited to have received the formal approval from FDA for our DiviTum®TKa assay, which is the first FDA cleared biomarker in this field. This is a very important milestone to realize the potential of the DiviTum®TKa product. We will now intensify our efforts to make DiviTum®TKa available for the benefit of breast cancer patients in USA before the end of this year,” said Anders Rylander CEO of Biovica.
The DiviTum®TKa approval is based on clinical data from the SWOG S0226 study and a so-called clinical validation study based on SWOG S0226. In the clinical validation study, the assay demonstrated excellent capabilities to identify non progressors with high negative predictive values, NPV, of 96.7% for progression within 30 days and 93.5% for progression within 60 days. This means that 96.7% of patients with DiviTum®TKa measurements below the assay clinical cut-off, did not experience disease progression within the next 30 days.