So we view this as our market to establish a new standard, and we’ve done all of the hard work to put ourselves in this position. So that’s where we came up with the number. And it’s not without precedent. So we’re looking back at other historical, again, historic examples of diagnostic services and products that have reached these key points of derisking across multiple milestones.
Christopher Glasper: Understood. Thanks very much.
Operator: [Operator Instructions] Our next question comes from Mark Massaro with BTIG. Your line is open.
Mark Massaro: Hey, guys. Thanks for taking the questions. And congrats on the milestones achieved in the calendar year. The first question I have, so obviously, you obtained FDA approval for KidneyIntelX DKD. In the press release, you noted that the DKD or the FDA-approved version has not yet been launched. Can you maybe clarify when you expect to launch the FDA-cleared version? And mechanically, like what needs to happen? Is it the label? Is it messaging, marketing? It would be helpful to learn what’s needed to go ahead and commercially launch the FDA-cleared version.
James McCullough: Yes. Thank you. It’s a very important point. And KidneyIntelX DKD and KidneyIntelX, we view as the same – effectively the same product or the same service, same biomarkers, same laboratory procedures. But you do have to, for example, build reimbursement around KidneyIntelX DKD. We have done – we are doing that successfully right now. So one of the key points is we need to make sure that we have Medicare payment established for KidneyIntelX DKD. All of the sales literature and educational literature needs to conform with now regulatory-regulated language. The sales force needs to be trained specifically on that language. In terms of some of the integrations we’ve done, we also have to shift, again, to the specific regulated language around KidneyIntelX DKD in the electronic medical record system.
So it’s not trivial. But it is a process we’re familiar with, and we have a lot of expertise, and we’ve been just putting one foot front of the other. So we’ll be in a position to actually launch the FDA product – the FDA service, actually most likely sometime early in the March quarter of this year. And Tom, I don’t know, are you connected at this point? Because you may want to amplify some of that.
Thomas McLain: Yes. I am here, James. Yes.
James McCullough: That’s good because I’m going to go horse taking over both sides of the script. Yes, do you have any additional commentary on Mark’s question on the availability of KidneyIntelX DKD in the process to put out the FDA service?
Thomas McLain: Yes. So the timing of the launch is driven by on the Medicare process, which will be completed with the price effective for 2024. And the process update, the marketing materials that are needed for the launch and everything required contractually is underway now. So that when the conversion to the FDA test happens, it will be simple and straightforward and accomplished on a date certain.
Mark Massaro: Excellent. That’s great color. So you were also included in the draft KDIGO guidelines. Is it your expectation that you’ll be in the final guidelines? And can we expect that roughly by the end of the calendar year 2023?
James McCullough: Yes, we can. We’re very excited about that. And it is actually this quickly, quite thrilling for us to be able to be included in such a prestigious guideline. I think this is the – either the 10-year or the 20-year revision on KDIGO. KDIGO is the leading guideline in the kidney space. It takes a lot of data generation, which we’ve invested heavily in. Certainly, it doesn’t hurt to have a full regulatory process behind you. So we think this is quite a significant event. We also expect that there will be other guidelines activities as well coming up hopefully, in the near term, you can never tell, and we say this with all humility but the goal, ultimately, is to be included in multiple guidelines around the diabetes, kidney disease, primary care framework.
And obviously, these are all independent committees doing independent evaluation work, you don’t have any control over any of this. But what you can do is produce evidence and have third parties produce evidence in multiple categories, and there’s no shortcut here. And it’s not cheap. You have to produce real evidence from a health economic standpoint. You have to produce outcomes data. And as you know, outcomes data is now becoming a critical feature in reimbursement. In fact, I would go so far as to say, if you don’t have outcomes data, you’re going to have a tough time getting comprehensive reimbursement. And generating outcomes data is a very special thing to do. It requires a lot of expertise, especially in a chronic disease from an early stage where a lot of the outcomes endpoints take several years to become apparent.
And then, of course, you need utility data. Are we changing behavior? Are we providing something that has benefit to, in our case, really primary care? Because it is at the front end of medicine where you get the most preventative aspects. So we’re really approaching kidney disease for the first time from a very early stage, at the front end of medicine where our therapeutics have the most benefit as little damage is done as possible to the organ. Patients have better outcomes. The costs can be reduced the most. If you wait until the patient progresses to late-stage disease, which is a lot of what’s happening right now in terms of uncontrolled progression, you can’t realize benefits in terms of outcomes, utility and health economics. So we’re starting at the preventative medicine angle.
And we’re generating an enormous amount of data, and there are third parties that are now using KidneyIntelX across their networks that are also generating and publishing on outcomes and utility. These are the types of things that can help support guidelines committees to look for inclusion. So we’re very happy. I don’t – I have never been able to achieve this many milestones this quickly in the product life cycle in under five years. It’s rare to see that done. And I think that’s really a testimony to the team that has designed a lot of these real-world evidence to show how KidneyIntelX can impact care in a number of ways and health economics in a number of ways. So I’ll stop there, but it’s very exciting to be included in the draft guidelines.
And yes, we do expect that the final guidelines will be published before the end of the year.
