Verici Dx (VRCI ) will expand the clinical validation study for its lead products, Claravaᵀᴹ and Tutevaᵀᴹ to allow for more verified data and to increase the overall robustness of the study.
The Company, which develops clinical diagnostics for organ transplants, has decided to expand the study by around four to six weeks despite the study having met its size criteria.
The Board said it does not expect this to have any impact on the Company’s recently outlined commercialisation pathway and that Verici Dx remains on track to present results to the clinical community at ATC (American Transplant Congress) in early June, as planned.
Verici Dx believes it will be able to meet its launch plans within this year, as expected. All the data from the validation study to date currently remains “blinded” and therefore the Company has not yet had access to the performance analysis of the study, it explained to shareholders.
The expanded study will allow for more verified data from European sites to be included; the reason for Verici’s decision is due to a delay in compliance visits from these study sites.
Verici said this is an important aspect to ensure the robustness of the study for commercial launch. “Unlike the US sites, where compliance monitoring can be undertaken remotely, the sites in Italy, France, and Spain require onsite in-person monitoring, which has recently been hampered by restrictions due to COVID-19, hence the delay in inclusion of their data,” it said.
Commenting on the company’s decision, Sara Barrington, Chief Executive Officer, Verici Dx, told investors: “Our timelines are such that we have the scope to make a positive strategic choice to increase the robustness of the study and ensure strong representation from our European partners, as we initially intended, without impacting our commercial timelines.
“Importantly,” she explained, “the study data remain blinded.” She explained that this was a decision that has been made in line with the original study design for geographic diversity, and it carries the added benefit of increasing the total number of patients in the validation study.
She added that Verici remains on track to present to the clinical community at ATC in early June and “to deliver on the launch plans for our two lead products by end of the year.”
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