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Biovica

Biovica

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FDA resource reallocation impacts DiviTum®TKa timeline

08:30 / 30 October 2020 Biovica Press release

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that it is reallocating resources to COVID-19 impacting the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last approximately 90 days during which time the FDA will not be able to continue reviewing Biovica’s submission.

The FDA has informed Biovica that it is handling a large number of Emergency Use Authorization (EUA) requests for in vitro diagnostics (IVDs) to address COVID‐19 and that a reallocation of resources is impacting the timeline for completion of the review of Biovica’s submission. The FDA currently estimates that the reallocation will last approximately 90 days, but states that the precise duration is not known due to the uncertainty associated with the pandemic, including the volume of future IVD EUA requests the FDA may receive.

Biovica will receive monthly updates regarding the anticipated timeline for reallocation of resources back to non‐COVID related activities and resumption of the submission review. When the FDA resumes the review, Biovica will provide an estimated time for completing the review.

“The ongoing pandemic is posing challenges for everyone in society, and we are not immune. We see the pause as temporary and hope that the FDA can resume normal activities as soon as possible. We continue to work toward making the test available to US patients as early as possible and are currently reviewing our timeline,” said Anders Rylander, CEO of Biovica.

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This information was distributed by MFN https://www.mfn.se/