FDA resumes review of DiviTum®TKa submission
Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510(k)-submission for DiviTum®TKa.
“This is fantastic news on our journey to make the test available to US patients as early as possible. 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. We look forward to working with the FDA to achieve clearance of DiviTum®TKa. We are building our organization in the US, preparing for US launch in 2021,” said Anders Rylander, CEO of Biovica.
Due to the high volume of Emergency Use Authorization (EUA) requests the FDA has received, and limitations on review resources, the FDA has also informed Biovica that it will not be able to complete the review within the usual 90 day MDUFA timeframe.
The 510(k) submission is based on 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 1700 samples. 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.