Joe Kim

Joe Kim asked for a comparison of the VISTA (PSC) and VANTAGE (PBC) study designs, specifically inquiring about key similarities and differences, and whether baseline pruritus scores in the PSC study are expected to be in a similar range to those observed in the PBC interim data.

Answer

CMO Joanne Quan explained that both studies share the commonality of investigating cholestatic pruritus, a well-characterized symptom, and utilize similar measurement methods. While PSC and PBC have different etiologies, the presence of intrahepatic cholestasis is common. She anticipates baseline pruritus scores in the PSC study to be comparable to the moderate-to-severe range reported in the PBC interim data.

Joe Kim asked for more details on the PSC study design, specifically highlighting similarities and differences between the VISTAS and VANTAGE studies, and whether baseline pruritus scores for PSC would be similar to PBC interim data.

Answer

Chief Medical Officer Joanne Quan stated that both studies focus on cholestatic pruritus, a well-characterized symptom, and share common implementation methods. She indicated that the PBC interim data, showing moderate to severe pruritus at baseline, serves as a good expectation for the PSC study.

Asked about the recommended frequency for Longitudinal Monitoring with OvaWatch, any reimbursement limits on testing frequency, the marketing strategy for the new publications, and the current landscape for endometriosis diagnosis, including the overlap with their current sales efforts.

Answer

The company stated that the frequency of OvaWatch repeat testing is left to physician discretion, with no current reimbursement limits. The new publications are being actively marketed through the sales force, inside sales, and KOL events. Regarding endometriosis, the diagnostic landscape still relies on invasive surgery, and there is a significant overlap in the target physician audience with OvaSuite, along with strong, pre-existing patient demand for better diagnostics.