Biovica - High activity preparing for US launch
FDA 510(k) clearance expected before end of Q3’21 Solid progress in commercial activities RUO orders from pharma companies a positive surprise New studies set to strengthen DiviTum’s documentation The key clinical utility of DiviTum in monitoring therapeutic effects is based on two key components: 1) reducing the use of imaging, and 2) reducing futile treatment. Two new prospective studies in metastatic breast cancer (MBC) were initiated to address these issues. An observational study with The Christie cancer centre in the UK (n=100; NCT04597580) will use biomarker(s) to delay imaging until the biomarker(s) show disease progression, as well as early detection of CDK4/6i resistance. To address futile treatment, the Prato Hospital in Italy initiated the TIRESIAS trial (n=150; NCT04660435), which will use DiviTum to predict overall outcome through a test performed after only two weeks on CDK4/6i+AI treatment (usually response is not recognised until 3-6 months into therapy).
On the webcast, it was also mentioned that Biovica is planning an interventional study which could take ~2 years to complete. Regulatory and commercial progress After disruption due to COVID-19, the FDA resumed its review of DiviTum’s 510(k) application in late January. Biovica now expects a decision before the end of Q3’21.
We also note that the company has continued to strengthen its US team, with a new Scientific Director in place. Biovica has also developed a budget impact model to illustrate the health economic benefits of DiviTum – an important tool in reimbursement discussions. We believe Biovica aims to ink a commercial partnership with a US laboratory (such as LabCorp, Quest Diagnostics, Sonic Healthcare, BioReference etc.
) before potential FDA clearance in Q3’21. New pharma orders a positive surprise in the Q3’20/21 report Biovica generated sales of SEK 1. 4m in its fiscal Q3’20/21, driven by two large orders from pharma companies in a Research Use Only setting used for drug dev.