Biovica completes 510(k) submission for DiviTum®TKa to the FDA
Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).
“The 510(k) submission is a major step towards bringing DiviTum®TKa to patients and we look forward to working with the FDA to achieve clearance of DiviTum®TKa. We see great value of the test in clinical practice, as DiviTum®TKa can enable provision of more tailored treatments for patients and for more efficient use of healthcare resources. Submission of the 510(k) application now keeps us on schedule for making the test available to breast cancer patients in early 2021,” says Anders Rylander, CEO of Biovica.
The 510(k) submission follows a successful clinical validation of DiviTum®TKa in a large study that analyzed data from over 400 US and Canadian patients with advanced breast cancer, with data from over 1500 samples. The patients in this study had been diagnosed with metastatic breast cancer. All patients had hormone receptor positive disease, a common form of breast cancer affecting about 70 percent of patients.
DiviTum®TKa is currently sold as Research Use Only (RUO) in the USA. With the 510(k) clearance from the FDA, Biovica will be able to address the much larger IVD market.