LONDON and NEW YORK - Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an AI-enabled in-vitro diagnostics company, announced that Medicare has issued a final Local Coverage Determination (LCD) for its kidneyintelX.dkd testing. Effective August 1, 2024, the test, priced at $950, will be covered for patients with Type 2 diabetes and Stage 1-3b Chronic Kidney Disease, as deemed reasonable and necessary by the LCD.
This coverage aligns with the U.S. Food and Drug Administration's label for kidneyintelX.dkd and follows the establishment of distinct CPT codes for the test in the CMS' 2024 Clinical Lab Fee Schedule. National Government Services, a subsidiary of Elevance Health, Inc., formerly known as Anthem (NYSE:ELV), Inc., and a Medicare Administrative Contractor, will process claims for tests performed in Renalytix's New York City laboratory.
James McCullough, CEO of Renalytix, expressed optimism that the Medicare coverage will encourage further major coverage decisions and expedite the adoption of the testing. He emphasized the company's commitment to sales growth in targeted U.S. regions, now supported by a lower cost of operations.
The kidneyintelX.dkd test was recognized as the first and only FDA-authorized prognostic test for early-stage Chronic Kidney Disease (CKD) risk assessment in patients with Type 2 diabetes (T2D) in late 2023. It aims to enable earlier intervention to improve patient outcomes and reduce healthcare costs.
This announcement is based on a press release statement.
InvestingPro Insights
As Renalytix (NASDAQ: RNLX) garners Medicare coverage for its KidneyIntelX.dkd test, investors may be eyeing the company's financial health and market performance. According to InvestingPro data, Renalytix has a market capitalization of $33.75 million, reflecting its position as a smaller player in the biotech industry. Despite the positive news, the company's financial metrics suggest challenges ahead. The revenue over the last twelve months as of Q3 2024 has declined by a significant 40.23%, indicating a contraction in sales that aligns with analysts' expectations of a sales decline in the current year, a key InvestingPro Tip.
The stock's performance has been notably volatile, with the price having decreased by 80.3% over the past year. This downward trend is further highlighted by a 49.22% drop in the last three months alone. The company's P/E ratio stands at -0.59, and it has been operating with negative gross profit margins, which suggests that Renalytix is facing difficulties in maintaining profitability. Another InvestingPro Tip to consider is that the company's short-term obligations exceed its liquid assets, raising concerns about its financial stability in the near term.
For investors seeking a deeper dive into Renalytix's financials and market potential, there are additional InvestingPro Tips available. These insights could provide a clearer picture of the company's trajectory and help inform investment decisions. To explore these tips and gain a more comprehensive understanding of Renalytix's performance, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
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