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Renalytix PLC on Friday reported another win for its flagship kidney disease test, pushing the company’s shares up nearly 30%. Renalytix is a London-based diagnostics company, focused on prognosis services for patients with chronic kidney disease. Shares in the company were up 28% at 13.08 pence each in London on Friday morning. This came after Renalytix announced the publication of a draft local coverage determination by the Centers for Medicare & Medicaid Services, the federal agency which administers healthcare coverage to over 100 million people in the US. The company previously requested an LCD for its KidneyintelX.dkd test, former called KidneyIntelX, which provides risk-ratings for patients with chronic kidney disease and type-2 diabetes and establishes the possibility of rapid kidney function decline. In Friday’s draft LCD, the CMS said it considered Renalytix’s KidneyIntelX test ‘reasonable and necessary’ for prognostic decision-making in patients over the age of 21 with type-2 diabetes and early-stage chronic kidney disease. Following this draft, Renalytix expects a final LCD within the calendar year. In June, the test received regulatory approval from the US Food & Drug Administration, and in October, Medicare established a pricing of $950 for the test. In January, Renalytix published data which it said demonstrated KidneyIntelX’s ‘broad implications for winning the war on chronic kidney disease’. The results included a 61% increase preventative drug prescriptions among patients in the high-risk group in the 12-months after undergoing the test. Copyright 2024 Alliance News Ltd. All Rights Reserved.
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