Biovica International AB (publ) today announced that the company received positive feedback from the FDA for the next step in the regulatory approval process. The feedback from the FDA ensures that the analytical validation is conducted in a manner that meets the FDA's requirements, so the product can get 510(k) clearance.
Biovica has previously communicated about a completed pre-submission to the FDA where risk class (II) and type of process (510(k) pre-market notification) were defined. Today, the company reports that also the next step in the process, supplementary 1, has been completed. Supplementary 1 comprise how analytical validation is to be carried out and how intended use of the product should be formulated to meet the requirements of the FDA.
Based on feedback from the FDA, analytical validation will be conducted to ensure test performance requirements will be met. In parallel, a supplementary 2 process to the FDA will be performed. It covers how clinical validation of the product will be carried out. As a next step, clinical validation will be performed before the FDA application will be submitted. This is planned to occur by the end of 2019 in line with what has previously been communicated. The clinical validation will be based on the already ongoing study program to a great extent.
The American market is important. Many new targeted treatments are introduced on the US market. However, new treatments do not help everyone. Hence, it is important with effective biomarkers in order to personalize treatments for best possible treatment outcome. Currently, evaluation using imaging technologies is standard practice which requires 3-4 months follow up in order to evaluate treatment efficacy. DiviTum®is developed to provide information on treatment efficacy faster than current practice. Results from clinical trials supports the conclusion that the assay can provide feedback on treatment effects already within 2-4 weeks. The assay requires a blood sample and the objective is to enable personalized treatments that results in better patient outcome and cost efficacy for the payers.
"The feedback from the FDA is important to us so that we can conduct analytical validation in a manner that ensures that we meet the FDA's requirements and in the long run receive a 510(k)-clearance so the product can benefit patients," says Karin Mattsson, Ph.D. R & D Director Biovica.
"It is a great achievement for Biovica to have passed another milestone in the regulatory approval process for the US market. This process and these milestones are important for meeting our objective, an approved product that can contribute to an individualized treatment for hormone-positive breast cancer and thus the best possible treatment results for the patients. " says Anders Rylander, CEO Biovica.