- Verici Dx PLC on Friday said it was planning to submit supplemental information to Medicare, in order to support the delayed local coverage determination for its Tutivia test.
The Cardiff, Wales-based developer of advanced clinical diagnostics for organ transplants said it now expects the process of coverage determination to continue into the first half of 2025, rather than the anticipated end of calendar 2024. As a result, Verici Dx will not recognise 2024 revenue from Tutivia until 2025.
The Tutivia test is a post-transplant blood test focused on acute rejection, rebranded from Tuteva in 2022. Verici noted it has been ‘well-received by clinicians’ and said that it is ‘pleased with the initial Tutivia test ordering and the levels of repeat ordering’. It expects order volumes to accelerate after the insurance coverage is established in 2025.
The company emphasised that the updated timeline has no effect on its year-end cash position, which it expects to be in line with unspecified market expectations. At September 30, it had $6.1 million in cash.
Chief Executive Officer Sara Barrington said: ‘Local coverage determination is important to our commercial strategy, and we are actively working with the assessment team to expedite the approval process. While this delay pushes back our short-term revenue expectations, our long-term outlook remains positive as we continue with the adoption of Tutivia.’
Shares in Verici Dx were down 15% at 5.50 pence each in London on Friday afternoon.
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