FDA resource reallocation continues to impact DiviTum®TKa timeline

2021-01-16 12:48

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact 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 another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica’s submission.

In October 2020, the FDA informed Biovica that its handling of a large number of Emergency Use Authorization (EUA) requests for in vitro diagnostics (IVDs) to address COVID‐19 implied a reallocation of resources impacting the timeline for completion of the review of Biovica’s submission. At the time, the FDA estimated that the reallocation would last approximately 90 days.

Due to the sustained volume of EUA requests the FDA has now informed Biovica that it is not yet able to resume the review of Biovica’s submission. The FDA currently estimates that the reallocation will last annother 90 days, approximately, but continues to state 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 continue to 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 reviewing our timeline,” said Anders Rylander, CEO of Biovica.


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