Proteomics International Laboratories Ltd. announced the achievement of a major milestone in the commercialisation of the PromarkerD predictive test for diabetic kidney disease with the approval of a new dedicated CPT Proprietary Laboratory Analyses (PLA) code for the test in the United States. The CPT PLA code--issued by the American Medical Association--is key to PromarkerD reimbursement being covered by both Medicare and private health insurers in the US, and hugely important for enabling affordable access and broad adoption of the test. The newly-approved code for PromarkerD (0385U) has been published and will be effective from 1 April 20233.

The PLA code was issued to Sonic Reference Laboratory, a CLIA certified, CAP and ISO 15189 accredited reference laboratory which is part of Sonic Healthcare USA (a division of Sonic Healthcare Limited). CPT, or Current Procedural Terminology, codes are widely used across the US to report medical procedures and services under public and private health insurance programs. The issuing of CPT PLA codes is done under a rigorous and open process that ensures codes that accurately reflect current clinical practice and innovation in medicine. A CPT PLA code uniquely identifies a test for the testing laboratory, enabling healthcare providers to order the test, facilitates a billing pathway for payers, and permits monitoring of test usage.

Early diagnosis of diabetic kidney disease using PromarkerD can help inform doctors' treatment decisions to improve clinical outcomes for patients, and could drive improved therapeutic interventions. Reducing or delaying the progression of the disease and consequently the incidence of dialysis and kidney transplant would result in significant cost savings for health care systems.