And most importantly, we’re validating reimbursement with depth and diversity. It’s not one coverage contract. It is payment — established payment coverage contracts across the universe of payers here, Blue Cross Blue Shield, Medicare, Medicaid, other private insurance groups. This is the diversity that you look to establish a long-term pattern of payment. And, of course, Medicare started all off with pricing KidneyIntelX at $950 reportable result. We have not compromised that. That’s very important. So — and then, of course, FDA regulatory. So once with those three legs in stool, you have substantial barriers to entry, you have a long-term competitive advantage because you’ve now set a very high bar, especially with the de novo marketing authorization through FDA.
Assuming we get there, it’s going to be very difficult to turn around and create a validated reimbursed regulated product to compete with KidneyIntelX. And so, that gives us room. And back to Dan’s question and yours, what we’ve been doing over the last 18 months is generating real-world experience with KidneyIntelX, in the wild. What happens, how does it happen, what are the objections, what are the support points, all of this goes into defining what has become a very clear, simple message to the primary care physician, which is a majority of our market. So, we know that greater than 90% of people with diabetes and kidney disease are in early stage, which is terrific because in the early stage, you can treat them more effectively before disease develops, before the costs start to spiral.
But you need to have a very simple message to primary care. And of course, the difficulty is getting into the simplicity. And as we said early on in the call, we’re now arriving at that tipping point. We accept all insurance. The data looks great, if you use it, it benefits patients, and it’s published. And then we hope very shortly to be able to say it’s FDA approved. So with that trifecta in place, we’ve now — we’re now — when that trifecta becomes in place, we’re now anticipating that we’re looking at putting in a very strong and direct to commercial program with sales and marketing focused on regions of the country where we have super majority insurance coverage and where there are large populations of patients with diabetes and kidney disease.
And we’ve given the list of where those are. So, this positions us well in the summer to really start to lean in to drive adoption. But it’s rare to have that trifecta in place in such a large effectively wide open market without a direct competitive threat in the near term. And that should start to generate results. Tom, I don’t know if you want to add to that.
Tom McLain: I think you covered that very well, James. Primary care is where the majority of these patients are seen today. The point that we expect to be at very soon with anticipated FDA approval is very simple, straightforward answers that clearly show Renalytix has achieved those three necessary pillars for success. And that will — that really eliminates the barriers that often limit introducing a novel innovative approach like KidneyIntelX into primary care. And we’re very excited to be at the point that we are at today.
Operator: [Operator Instructions] Our next question will come from Mark Massaro of BTIG.
Mark Massaro: Hey, guys. Good morning. Thanks for the questions. The first one is, James, can you perhaps provide an update on communications you’ve received from the FDA? I know you’ve indicated that you’re hopeful to obtain approval by the end of June, end of this month. But I’d be curious to hear, like, are you still having some back and forth dialogue between you and the agency? And then, I know you’ve talked about how the agency plans to provide — or prepare reclassification order to complete its review. Just any update you could provide there, I think, would be helpful.
