Biovica: The US lab secures the CLIA certification - Redeye

Biovica’s US lab secures a CLIA certification following a successful site visit in January. This progress allows Biovica to supply the US market with an FDA-approved DiviTum test from the Biovica lab in San Diego. The approval will allow Biovica’s US team (at least 13 persons) to initiate the go-to-market plan. We look forward to more details regarding the initial commercial progress at the time of Biovica’s Q3 report (due on 16th March). We also expect Biovica to set a launch objective for Biovica’s 2023/24 year (Biovica has a split accounting year ending April), possibly in terms of range relating to the number of clinics testing DiviTum clinically or a similar relevant launch target. By the Q4 result (due 21st June), Biovica will have a 3-4 month early launch experience, and this could be a good time to set a target range, including feedback from the initial launch. The initial positive share price reaction (4-6%) is, in our view, justified both become of the importance of the CLIA certification and the importance of avoiding any further delays.

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