Truly innovative medical science changes people's lives. That could soon be true of Verici Dx's (VRCI) Clarava pre-graft blood test - today the company reported positive clinical data from its pivotal, 122 patient blinded validation study across 13 international centres.
Here this first-of-its-kind prognostic achieved 78% sensitivity, 64% specificity and was statistically shown to be able to accurately predict which kidney transplant patients are more susceptible to organ rejection in the critical first 60 to 90 days post-operation.
That means that, based on an individual's unique RNA signature, doctors can now personalise treatment and monitoring regimes immediately post transplant - and thus vary dosage levels of immuno-suppressants and steroids - in order to improve organ acceptance rates and patient outcomes.
Currently there are no such competing products available, despite an estimated global addressable market of 65,000 procedures each year -existing approaches to assess rejection risk are simply based on a recipient’s race, age, previous transplant history and whether they have antibodies against common donor antigens.
But that's not all. Elsewhere, the results also demonstrated that using Clarava would be an excellent way to identify between high and low risk groups - with the former being approx 6 times more likely to suffer a rejection event.
This is hugely important, since presently between 37%-50% of all kidney transplant patients suffer rejection events in year 1. That failure rate is extremely expensive, as each surgical procedure is estimated to cost more than $440k, and there are over 500k citizens alone in the US on dialysis machines, which cost more than $40k a year each, with end-stage chronic kidney disease.
So what’s next? Well, Clarava has already received preliminary Medicare gap-fill reimbursement cover of $2,650/test and is on track for US commercial launch by the end of 2023.
CEO Sara Barrington commented: “This validation for Clarava is the 2nd successful product to emerge from the Company’s suite of prognostic RNA signature tests and further validates our underlying technology platform. With Tutivia commercially launched as a measure for post-transplant rejection risk, the addition of Clarava as a pre-transplant test is a significant milestone in our strategy of building a complementary suite of ground-breaking products that offer end-to-end testing for kidney transplant patients and their clinicians, to help personalise care and transform outcomes.”
At a net $9.8m as at December 22, or 4.5p a share, the business has sufficient cash resources to fund itself until mid 2024. Broker Singer Capital Markets is forecasting turnover to climb from $0.9m in FY23 to $6.1m next year and rate the stock a buy.
Verici DX's latest trial success lays the foundation for explosive growth
Jul 3, 2023Disclaimer & Declaration of Interest
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