And I think that that’s also what’s underpinning and helping to drive increased utilization in our system. So this is something that is really quite important. We’re seeing outcomes that have shown the substantial need for our technology. Two different randomized controlled trials presented pilot results last year. And the amazing thing about these two different RCTs, one was from Duke. One was from the VA center, is that in both pilots, they asked clinicians what they thought the blood volume was of the patients using the existing technology and then measured it with blood volume, our system, which is 98% accurate and then compared the two. And what they found was really astonishing, it turns out that according to the VA study, 70% of the time clinicians are getting either the total volume or the red tile volume long of these patients.
Categorically, 70% of the time the Duke City also had a similar finding that 50% of the time they were getting the volume wrong. They didn’t actually look at what percentage of the time they were getting the red cells wrong, but that would probably be of a similar order of magnitude if it matches the VA study. What does that mean? It means that there’s really a lot of suboptimal care going on out there that if the clinicians knew the volume accurately, they would be getting much better results and that’s becoming increasing there in study after study. So I’ll sort of wrap up there and start to go into more of the very specific questions that I’ve received. And I think that, that’s going to be able to lead to a good segue to talk about the acquisition that Daxor announced this morning, which is really quite important.
So just wrapping up in terms of the 2023 results. We’re continuing to see a strong increase in the utilization of our product. We’ve made important strides in terms of the next-generation analyzer, just to give people a sense of it, we submitted for the 510(k), as I said at the end of Q4, that is a traditionally, it’s a 90-day review process for the 510(k) and a 90-day review process for the CLIA waiver. So we are about 85 days into the review for the 510(k) piece of it. We don’t really know exactly when in this 180-day window, the FDA will give us any feedback as soon as we do know and we are able to move forward. And of course, we’re going to keep all of our investors apprised of that. We’ve been making preparations, though to build and manufacture units in anticipation of clearance, and we’ve been doing work behind the scenes in order to drive the adoption and the messaging that’s necessary for the marketplace once we are allowed to actually market the products.
So with that, I would like to just sort of briefly pivot and talk about the announcement that we made this morning. Iso-Tex Pharmaceuticals of Friendswood, Texas is a private radiopharmaceutical manufacturer. They have been providing us with inputs into our test kits for the last period of time, and they are what we would consider a key supplier. In addition, they also manufacture and sell a product called Glofil. So let me first explain Megatope and Volumex. Megatope and Volumex are the two drugs that they manufacture on our behalf and combine those with other elements and then sell them in test kits. We have entered into an agreement that calls for us to acquire the exclusive worldwide rights to manufacture Volumes and Megatope from them.
In addition, a third FDA proved drug called Glofil will also be acquired by Daxor. So Daxor owns and operates a 20,000 square foot state-of-the-art facility in Oak Ridge, Tennessee. We have clean rooms there. We have the ability to manufacture FDA approved products there. So we will be taking those products in-house. This agreement does not require Daxor to make any sort of substantial additional capital investment. We’re going to really leverage the existing footprint that we have in order to operationalize these drugs for our purposes. Megatope is an input into the manufacturing Volumex. The Volumex itself is the drug that we are packaging into our test kit. So the impact of us taking Volumex in-house for our margins, we anticipate could be quite substantial.
It’s going to really affect our margins depending upon how our business scales, which obviously will not surprise people, but I would say that it would probably lead to a minimum of a 15% increase in our margins for our Volumex products, which would increase over time as our business continues to scale up. We do have the ability, we estimate at our facility in Oak Ridge, Tennessee with what’s there to make approximately between 200,000 and 300,000 test kits a year. So there’s ample room for expansion and for growth within our facility. So we have a lot of room to scale up in our existing footprint without having to make further investments to bring the product to the next level. As far as Glofil goes, Glofil is a product which is used for the measurement of glomerular filtration rate.
And this is an exciting product for us for a number of reasons. Glomerular filtration rate is a different metric than blood volume, but it is often a metric that is considered by nephrologists in relation to blood volume. In other words, people like to look at the kidney function of a patient along with the circulating volume and the red cell volume to understand a complete picture of what’s going on, typically in a cardio renal scenario or in the question of hyponatremia and cerebral salt wasting syndrome. So this drug fits in very, very well for us at Daxor. It has an existing footprint of customers. And while its sales right now are really focused in the nephrology area, it’s something that is very ripe for development that they have an existing customer base of approximately 20 customers that are regularly ordering this product.