Biovoca FDA Approval: A late qualifier for a pole position
Research Note
2022-08-01
07:53
Finally, Biovica has secured US approval (510k) for DiviTum in the core market indication. The approval is to use DiviTum to aid in monitoring disease progression in previously diagnosed hormone receptor-positive, metastatic postmenopausal female breast cancer mBC. The company is now a Dx (broad sense) with an approved clinical marker on the US market.
JU
Johan Unnerus
Disclosures and disclaimers