LONDON and NEW YORK – Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, announced that Medicare has issued a final Local Coverage Determination (LCD) for the kidneyintelX.dkd test. Starting August 1, 2024, the test, priced at $950, will be covered for patients with type 2 diabetes and stages 1-3b chronic kidney disease, as deemed reasonable and necessary by LCD.
This coverage is consistent with the U.S. Food and Drug Administration label for kidneyintelX.dkd and follows the establishment of separate CPT codes for the test in CMS’s 2024 Clinical Lab Fee Schedule. National Government Services, a subsidiary of Elevance Health, Inc. formerly known as Anthem, Inc. and a Medicare administrative contractor, will process reimbursement claims for tests performed in Renalytix’s New York laboratory.
James McCullough, CEO of Renalytix, said he is optimistic that Medicare coverage will encourage other important coverage decisions and accelerate adoption of the test. He highlighted the company’s commitment to sales growth in targeted US regions, now supported by a lower operating cost.
The kidneyintelX.dkd test has been recognized as the first and only FDA-authorized prognostic test for assessing the risk of early chronic kidney disease (CKD) in patients with type 2 diabetes (T2D) in late 2023. The goal is to enable earlier intervention to improve patient outcomes and reduce healthcare costs.
This announcement is based on a press release.
Insights from InvestingPro
As Renalytix (NASDAQ: RNLX) gains Medicare coverage for its KidneyIntelX.dkd test, investors may be watching 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 sector. Despite the positive news, the company’s financial metrics suggest there are challenges ahead. Revenue for the trailing twelve months, as of the third quarter of 2024, decreased by a significant 40.23%, indicating a contraction in sales that aligns with analysts’ expectations of a decline in sales in the current year, a advise key by InvestingPro.
The stock’s performance has been remarkably volatile, with its price dropping 80.3% over the past year. This downward trend is further highlighted by a decline of 49.22% in the last three months alone. The company’s P/E ratio stands at -0.59, and the company has been operating at negative gross profit margins, which suggests that Renalytix is having difficulty 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 looking to delve deeper into Renalytix’s financials and market potential, there are others available InvestingPro tips. These insights can provide a clearer picture of the company’s trajectory and help inform investment decisions. To explore these tips and get a more complete understanding of Renalytix performance, use the coupon code PRONEWS24 to get an additional 10% discount on a one-year or two-year Pro and Pro+ subscription to InvestingPro.
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