Verici Dx is developing a complementary suite of proprietary, leading-edge tests forming a kidney transplant diagnostics platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence (AI) assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage.
Verici Dx provides investors with the opportunity to access a [high potential diagnostics company. We believe the company has strong growth potential due to the following key drivers
The Company develops tests to understand how a patient is likely and may be responding to an organ transplant. The Company’s products and solutions are underpinned by extensive scientific research into how the recipient’s immune phenotype is likely to respond to the transplanted organ and how that response further influences acute rejection, chronic injury and, ultimately, failure of the transplant.
Verici Dx’s two lead products are:
The Company is also working on a third product, ProtegaTM, a liquid biopsy that aims to predict the risk of fibrosis and long-term graft failure, which together with ClaravaTM and TutiviaTM will allow Verici Dx to offer end-to-end testing for kidney transplant patients and their clinicians, enabling the Company to improve outcomes for patients and also establish a strong competitive advantage..
In June 2022, the data from Verici Dx’s international, multi-centre validation study for Tutivia™ was published. This demonstrated a significantly higher Positive Predictive Value (“PPV”) than currently available kidney transplant single blood tests, demonstrating that the test was able to provide clinicians with an appropriate, reliable call to action to improve patient outcomes post-transplant. Tutivia™ established a new industry standard and set the foundation for the tests soft launch, which was achieved in December 2022, followed by commercial launch in January 2023.
Clarava™’s early validation study results were announced in September, and indicated that the test was able to identify pre-transplant patients most likely to experience a future kidney rejection event. To generate a broad clinical acceptance within the diverse transplant community, the Company decided to extend enrollment for six months using its existing clinical trial network.
These kidney transplant diagnostics products are planned to be offered as laboratory developed tests (“LDT”) in the US, taking advantage of the lighter regulatory burden of authorisation under the CLIA (Clinical Laboratory Improvement Amendments) regime which is administered by CMS (the Centers for Medicine & Medicaid Services), in partnership with state health departments, rather than seeking clearance from the FDA.
In Europe the company will be seeking CE marking. The CE marking issued by an EEA (European Economic Area) Notified Body will remain valid in the UK market until 30 June 2023. To address the UK market post-Brexit, the company will be seeking for UKCA (UK Conformity Assessed) mark as well. In addition to obtaining CE and UKCA markings, the products (the devices) will be registered with MHRA as required by MHRA after 1 January 2021.
The Company is planning on complementing this commercial path with an efficient route through reimbursement coding, pricing and coverage determinations in the US. For inclusion into NICE guidelines in the UK, evidence-based data (such as health economic cost-effectiveness and patient outcome/clinical-effectiveness data, along with diagnostic test accuracy data), shall be applied for review by NICE Diagnostic Assessment Programme.