Shares of Renalytix PLC (AIM:RENX) surged 28% in early trading after the Centers for Medicare & Medicaid Services (CMS) announced a price of $950 for the company's FDA-approved kidneyintelX.dkd test.
The test, which uses artificial intelligence (AI) to predict risks for people with type 2 diabetes and chronic kidney disease, will be listed on the nationwide Clinical Laboratory Fee Schedule starting 1 January, and the price will be locked in for at least three years.
Earlier this year, an American Medical Association (AMA) panel recommended that this advanced test get its own unique code to set it apart from the original KidneyIntelX test. This led to a national pricing review by CMS, confirming the $950 price tag.
Renalytix believes this pricing decision, backed by expert and public reviews, not only validates the value of their KidneyIntelX platform but also makes it easier to expand health insurance coverage for the test in the US. The company also sees this as a strong basis for pricing in international markets.
At 9.05 am, the shares were changing hands for 79.98p, up 17.48p on Monday's close.