Biovica Expects CLIA Certification During First Quarter 2023

The Laboratory Field Services (LFS) of California Department of Public Health (CDPH) has informed Biovica that it has scheduled an on-site visit of Biovica’s new laboratory in San Diego, California, in January 2023. Thus, Biovica now expects to receive Clinical Laboratory Improvement Amendment (CLIA) certification during the first quarter 2023. This does not impact the planned and ongoing commercialization activities.

“Our team is looking forward to showcasing our laboratory to CDPH as a final step in the CLIA certification process. In parallel, we continue to advance our commercialization activities to drive demand for DiviTum® TKa. Our US customer facing team that was hired first of December will engage KOLs, regional thought leaders and medical oncologists while our Market Access team will engage targeted cancer centers. The DiviTum® TKa launch activities are well under way and our timeline is not impacted by this site visit. We expect to analyze the first DiviTum® TKa samples during the first quarter 2023,” said Warren Cresswell, Biovica President Americas.