Biovica: Achieves 510(k) clearance for DiviTum - ABG

The long-awaited FDA decision announced on 30 July

Management looks to have the test available by year end

Opens up USD 200-350m annual market opportunity

FDA gives DiviTum 510(k) clearance
On Saturday 30 July, Biovica achieved a major milestone when it announced that the FDA has granted 510(k) clearance for its cancer biomarker DiviTum, effectively opening it up for sales and clinical use in the US. We believe this announcement has been long awaited from multiple stakeholders, as the review process has been severely delayed due to longer lead and response times at the FDA during the COVID-19 pandemic.

Moving from clinical development to commercial phase
With Saturday’s news Biovica enters a new phase as a company with focus now on commercialization and generating sales and less focus on clinical trials and regulatory processes. In the press release, CEO Anders Rylander stated that it will intensify its efforts to make the product available to patients in the US before the end of this year. Near-term we believe the key objective will be to get its lab facility up and running and CLIA certified. In the longer term, we believe a key factor to facilitate a high uptake will be securing sufficient reimbursement coverage.

Opens up USD 200-350m per year market opportunity
The 510(k) clearance specifies to “aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients”. This is the target patient population it has set out for DiviTum and on an annual basis it corresponds to 31k new patients. According to Biovica, the US market opportunity is USD 200-350m per year, based on a pricing assumption of USD 300-500 per test and a recurring monitoring regimen for three lines of therapy.
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