NEW YORK— Biomarker test developer Biovica has filed a 501(k) submission with the US Food and Drug Administration for its DiviTum assay for monitoring breast cancer treatment response.
The submission follows a successful clinical validation study of Biovica's test, which analyzed data from 1,500 samples collected from US and Canadian patients with advanced breast cancer. The Uppsala, Sweden-based firm inked an agreement with the SWOG Cancer Research Network last September to study the clinical benefit of the DiviTum assay using blood samples from women with metastatic HR+ breast cancer.
Biovica's DiviTum immunoassay measures the activity of the thymidine kinase (TK) enzyme in a patient's blood serum or cell cultures. Biovica currently offers the test for research use only in the US.