Olaris is pleased to announce the American Medical Association granted a unique PLA code (0542U) for the myOLARIS-KTdx immune status test developed to monitor kidney transplant recipients. The NUS HSQC NMR-based algorithm analysis is the first of its kind to be granted a CPT code, which will be effective on April 1, 2025.
FRAMINGHAM, Mass., Jan. 22, 2025 /PRNewswire-PRWeb/ -- Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARISâ„¢ diagnostics products, announced that the American Medical Association (AMA) granted a unique PLA (proprietary laboratory analysis) code (0542U) for their myOLARIS-KTdx test, a non-invasive assessment of a unique metabolite panel from a urine-based specimen to assess immune status throughout post kidney transplant care. The code will be effective on April 1, 2025. The code is the first ever common procedural terminology (CPT) code that utilizes a metabolomic NUS (non-uniform sampling) HSQC (heteronuclear single quantum coherence) NMR-based algorithm analysis.
"We are committed to developing tools to revolutionize the entire transplant journey", said Dr. Elizabeth O'Day, CEO and Founder of Olaris. "We are proud of achieving this milestone in the launch of our immune status monitoring test, which demonstrates the clinical application of metabolomics and paves the way for future NMR-based diagnostic applications."
Accurate post-transplant monitoring of immune status remains a clinical challenge. Current biomarkers are either lagging indicators of injury or have been developed as rule-out assays focused on active rejection with limited clinical value as a rule-in assay for rejection, borderline rejection, subclinical rejection or broader types of graft injury such as polyomavirus associated nephropathy (PVAN). The myOLARIS-KTdx algorithm utilizes a urine-based metabolite signature and clinical data to detect and differentiate a stable graft from graft injury including borderline rejection, subclinical rejection and active rejection due to under-immunosuppression and PVAN due to over-immunosuppression.
"This test has great potential to add to value-based care in the post-transplant period", said Dr. Ravinder Wali, Professor of Medicine, University of Massachusetts Chan School of Medicine and UMass Memorial Health Care, "Kidney biopsies are invasive procedures that we would like to avoid if possible. From a urine sample, myOLARIS-KTdx provides precise information that helps optimize individual patient immunosuppressant medications mitigating the risk of kidney graft injury due to either under-immunosuppression or over-immunosuppression."
"Finding a balance in the level of immunosuppression is key to better outcomes for kidney transplant recipients and lengthening the life of the transplanted kidney. There is a huge need for an assay like myOLARIS-KTdx to distinguish stable graft, under-immunosuppression or over-immunosuppression. It also has the potential added value of showing immunosuppression compliance." said Dr. Anil Chandraker, Professor and Chief of Renal Medicine University of Massachusetts Chan School of Medicine and UMass Memorial Health Care.
About Olaris
Olaris Inc. is working to fundamentally change how diseases are treated and diagnosed. By leveraging our myOLARIS toolbox which combines metabolomics, machine learning and biology we uncover clinically impactful biomarkers. To learn more visit .
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