US clinical laboratory now fully accredited in 49 states
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that further to the RNS dated 2 March 2023, the Company has received compliance authorisation for the operation of its commercial clinical laboratory testing in respect of samples from an additional four US states, including the important addition of California, with the Company laboratory now fully accredited in a total of 49 states.
Together with the CLIA certification previously obtained from the Centers for Medicare & Medicaid (“CMS”), clinicians at transplant medical centres in these additional states are now enabled to order Verici Dx’s transplant tests, expanding the Company’s commercial reach. California has consistently accounted for over 10 per cent. of the national US volume of kidney transplant procedures in each year since 1998 and has conducted the highest volume of transplants by any state each year over the same period.
Verici Dx launched its first product, Tutivia™, for the detection of acute rejection in kidney post-transplant patients, in January 2023 and recently announced the successful validation of Clarava™, a first-in-class pre-transplant prognosis test for the risk of early acute rejection in deceased donor recipients, which it expects to launch later this year. The additional state accreditations provide further validation of Verici Dx’s clinical laboratory for its tests to be used by transplant clinicians across the US.
The Company continues to work towards full accreditation in the final state of New York, which has its own
compliance requirements.
The CLIA certification and additional state approvals further exemplify Verici’s commitment to a quality-focused approach to providing advanced kidney transplant diagnostic services to clinicians and patients in need.
Sara Barrington, CEO of Verici Dx, said: “This is another important step in our strategy, expanding our commercial reach and making it easier for clinicians to order our tests helping to drive the adoption of both Tutivia TM and Clarava TM .”
Sara Barrington, CEO Julian Baines, Chairman
www.vericidx.com Via Walbrook PR
N+1 Singer (Nominated Adviser & Broker) Aubrey Powell / Kailey Aliyar / Tom Salvesen
Tel: 020 7496 3000
Walbrook PR Limited Paul McManus / Sam Allen
Tel: 020 7933 8780 or vericidx@walbrookpr.com Mob: 07980 541 893 / 07748 651 727
Sara Barrington, CEO
Julian Baines, Chairman
www.vericidx.com
Via Walbrook PR
N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen
Tel: 020 7496 3000
Walbrook PR Limited
Paul McManus / Sam Allen
Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 / 07748 651 727
Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant 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 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. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.
Verici Dx's two lead products are Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.
