Renalytix (RENX) , an AI-enabled in vitro diagnostics company, has announced that Medicare has priced its FDA authorised kidneyintelX.dkd kidney function test at $950.
KidneyIntelX.dkd is a test that helps predict if adults with type 2 diabetes and early-stage kidney problems are at risk of rapidly progressive decline in kidney function.
Because it was recommended by the American Medical Association that KidneyIntelX.dkd should receive a new code for clear distinction from the original Laboratory Developed Test (KidneyIntelX), the recommendation also required a national Medicare pricing review that has now confirmed a published price on the national Clinical Laboratory Fee Schedule of $950.
This pricing, effective January 1, 2024, underscores KidneyIntelX's value and streamlines US health insurance coverage maintenance and expansion through international distribution agreements.
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As Renalytix notes, the pricing serves as a strong basis for strengthening its adoption in the US, alongside helping expansion through international distribution agreements, potentially opening doors for the global adoption of kidneyintelX.dkd. The company’s shares rose 8% on the news.
Over 37 million Americans (approximately 1 in 10) have diabetes, with about 90-95% of them having type 2 diabetes. Demand for KidneyIntelX.dkd is augmented by the fact that many people remain undiagnosed, with approximately 23% of adults unaware they have type 2 diabetes. Furthermore, type 2 diabetes affects various vital organs such as the heart, blood vessels, nerves, eyes, and kidneys, with diabetic kidney disease developing in 30-50% of individuals with type 2 diabetes.
KidneyIntelX.dkd is underpinned by Renalytix’s KidneyIntelX platform, which combines blood-based biomarkers with clinical variables using an AI-enabled algorithm, providing information to guide care in large, at-risk patient populations.
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