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02 Apr 2024
More bandwidth at McKesson

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More bandwidth at McKesson
- Published:
02 Apr 2024 -
Author:
Solvet Hugo SH -
Pages:
9 -
What happened?
QuidelOrtho (not covered) announced that they have withdrawn FDA submission for their RVP4+ assay (Flu A/B, RSV and Covid), initially submitted in July 2023. See statement below. They expect to get their next generation RVP4+ assay approved ahead of the 2024/2025 flu season.
''Data generated over a 9-month period for the four viruses targeted by the assay initially showed great promise, which led to the FDA submission in July 2023. However, the final dataset, submitted in February 2024, did not meet our expectations. In addition, during the pendency of the submission, the Company has continued to develop the next-generation RVP4+ assay. The Company anticipates the new multiplex assay to be commercially available during the 2024/2025 respiratory season.''
BNPP Exane View:
This news reads positively to BioMerieux.
. Competition within McKesson, which also distributes QDEL Savanna (link here), should temporarily be of lower intensity. This could benefit BioMerieux, as their distribution agreement with McKesson is expected to go live in Q2. As a reminder, BioMerieux got FDA clearance and CLIA waiver approval for their respiratory Large and Mini-plex panels last year (May 2023) and more recently for their 15-plex respiratory/sore throat panel (5-plex panel approval expected in the coming months).
. This also underlines high barrier to entry in developing low- and high-plex molecular respiratory panels, in our view.
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