Verici Dx (VRCI ) said it has been granted CPT® Proprietary Laboratory Analyses (“PLA”) codes1,2 for both its Clarava and Tuteva tests by the American Medical Association (“AMA”).
The clinical diagnostics developer told investors that the new codes have been approved and published by the AMA Editorial Panel and are scheduled to become effective on 1 April 2022.
PLA Codes are an addition to the CPT® code set approved by the AMA CPT® Editorial Panel. Specifically, the PLA codes are alpha-numeric CPT codes with a corresponding descriptor for labs or manufacturers that want to more specifically identify their test.
Tests with PLA codes must be performed on human specimens and must be requested by the clinical laboratory or the manufacturer that offers the test, the AMA has previously outlined.
CPT codes are medical codes that are used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organisations. The codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review.
Commenting on the news, Patti Connolly, Executive Vice President, Product Development of Verici Dx, said: “We were delighted with the AMA’s decision as CPT® codes are fundamental in the commercialisation of our lead products.” The Company added that the successful granting of a CPT® code marks “the first step on the path for commercial reimbursement.”
‘Reimbursement in the US consists of three components: code, price and coverage. CPT® codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT® PLA code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers,’ the Company outlined to investors.
Verici Dx’s Clarava™ assay is a pre-transplant prognosis test for the risk of early acute rejection, while Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection.
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In August 2021, Verici said patient enrollment for a multi-centre observational clinical validation study for its lead products had concluded ahead of management expectations.
Having completed its enrollment early, the developer of advanced clinical diagnostics for organ transplants said it remains on track to complete the validation study for these products by the end of 2021, in line with expectations set out in the Company’s admission document.
Verici Dx has partnered with eleven leading US and EU centres to date to run a global, non-randomised study for the clinical validation of its lead products, Clarava and Tuteva.
The Group’s Clarava™ assay is a pre-transplant prognosis test for the risk of early acute rejection, while Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection.
The study uses next generation sequencing in the Verici Dx lab to create transcriptomic profiles to validate performance characteristics of the lead Verici Dx signature tests.
Over the longer term, the study will also provide validation for a fibrosis test called Protega™. The patient enrolment process for Protega which is ongoing is expected to complete by 3Q22.
The end points of the study for this product are expected to be reached up to two years after the completion of enrolment, with data expected shortly thereafter around year-end 2024.
To date, enrolment is on target for completion of the Clarava and Tuteva validation study by the end of 2021 with data expected to be published ‘as soon as practicably possible’ in 2022.
Its efforts to accelerate the use of its organ transplant products comes at a time when the landscape of solid organ transplantation has dramatically changed as a result of COVID-19.
While developing, trialling and obtaining the necessary regulatory authorisations before launching medical technologies can be a lengthy process, Verici said it is focused on compressing these timescales with the aim to commercialise its kidney tests in 2022.
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