Ross Osborn: Good morning and congrats on the quarter. Just one for us. Would be curious to hear if there’s any update on the pipeline with regard to nephritis? And if you can provide any more color on where you are in terms of time to market? Thank you.
John Aballi: Sure. Good morning, Ross. I got the first question. The second question was timing to market for those, just to be clear.
Ross Osborn: Yes, that’s correct. Thank you.
John Aballi: Okay, great. Thanks for the clarification. So in terms of our R&D pipeline, in terms of what’s occurred over the last six months, the key cornerstones when I joined the company were the RADR program, which was therapeutic selection in the context of rheumatoid arthritis along with the fibromyalgia diagnostic assay and then some therapeutic response assays in the interferon space as well. So at the time, we took a pretty detailed approach to this. I’m a big fan of setting up the criteria for success before conducting the evaluation. And so we put this criteria in place and we thought that if we can identify technologies that were kind of one, proprietary in nature; two, have an ability to demonstrate clinical utility that we thought was realistic; three, have the ability to achieve value-based pricing.
We believe that you have to have some certainty in your reimbursement before launching a product. So Medicare coverage was a fourth component here. Also, we want to develop products that meet customer needs, existing customer needs. So that was another component. And then lastly, really having fleshed out the guidelines strategy, I think having inclusion in guidelines or at least a pathway to getting there is incredibly important when you’re weighing whether or not to move forward with a given opportunity. And so we put those in place as a way to evaluate the pipeline. It ultimately resulted in discontinuing quite a few of the projects that were in the existing pipeline. But we’ve rekindled some of those efforts in the context of really owning the lupus patient journey.
That’s kind of how we’re doing it internally. And so we have a program ongoing now to take a look at both diagnostic as well as therapeutic monitoring or disease activity in lupus nephritis. So this is the indication where you have inflammatory flare in the context of lupus but related to the kidney, it’s potentially life threatening, very significant consequences for the patient. And unfortunately it’s detected oftentimes late stage when the kidney has progressed quite a bit in the context of that inflammatory state. There’s also therapeutic options on the market that are available. You have a couple from some pharma companies that bid on the market for a little bit of time here. So we believe that’s a pretty exciting opportunity we’re pursuing.
We’re also looking at lupus in general from a disease activity standpoint. Right now, there’s some clinical nomograms that exist, but they’re extremely cumbersome, very time consuming to execute or not done practically in the community setting. And really understanding how the disease is progressing over time is essential to modulating therapy in this context, so exciting for us to develop something here. And I think we have some great initial data showing we can do so. And then there’s a few other projects that we’re working on. What I’ve really committed to externally is talking about some of our pipeline products as we have meaningful developments, not so much selling the future on the come. We’re very excited about the potential for AVISE CTD and the ASP improvements that we believe will develop here over the next several quarters, and well into 2024 into 2025.
