Verici Dx sees 68% Q1 growth in Tutivia test orders, Medicare coverage decision imminent
Given the uncertainty caused by Trump's trade tariffs and Elon Musk's cost cutting measures at the US FDA and NIH agencies, advanced kidney transplant diagnostics firm (mrkcap £7.9m) released a prudent trading update this morning.
Despite posting its highest-ever quarterly order intake of Tutivia tests (292 units), up 68% Q1'25 vs Q4'24 sequentially (334 units in 2024), the company is still waiting for formal Local Coverage Determination (expected imminently) from MolDX before it can invoice these tests at the approved price of $2,650 each.
Here, the business is working with 19 leading US kidney transplant centres as they embed Tutivia into their clinical pathways, which will further encourage strong levels of repeat ordering.
In terms of balance sheet, $750k should be received shortly from strategic partner Thermo Fisher Scientific (re licensing/transfer of PTRA or Clarava) that, together with net funds of $1.63m as at 31st Mar'25, will ensure the group has a cash runway until the end of June 2025.
Hence, after receiving the LCD decision and over the next 3 months, the Board will seek to raise fresh capital, which house broker Singer Capital Markets estimates will be c. $5m in order to extend the cash runway for a further 12 months.
CEO Sara Barrington commenting: "The significant increase in Tutivia orders for Q1'25 reflects how it directly addresses areas of unmet need in transplant, as well as general utility - and demonstrates it is being very well received by clinicians who are passionate about improving their patient outcomes."
"We previously said that adoption of innovative products is sensitive to establishing comprehensive insurance coverage and we recognise that the lack of coverage through 2024 slowed the pace of adoption. That said, we are pleased with the initial Tutivia test ordering, the levels of repeat ordering, and we still expect volumes to further accelerate as insurance coverage is established."
With regards to revised guidance, the Board anticipates FY24 revenues of $3.3m and adjusted LBITDA of -$5.4m, in line with expectations. For FY25, Singer Capital Markets is forecasting revenues to climb to $4.4m, with adjusted LBITDA coming in at -$4.7m.
's technology is unique because the 'RNA signature' platform assesses (re 79% Positive Predictive Value for Tutivia) the risk of organ rejection BEFORE damage has actually occurred. In comparison, most (if not all) other rival tests rely on measuring 'debris' in the bloodstream - ie once organ damage has already occurred, which is frankly too late.
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