With that said, we continue to work towards the double-digit number for next year. As we get into the February quarter, we’ll start to size that up more and define that a little bit more. But for now, definitely expecting the fourth quarter to have some headwinds and planning for that.
Dan Brennan: Got it. And then maybe just one on kind of Alzheimer’s. How should we be thinking about, the sensitivity specificity of a blood-based test as compared to PET when we think about both rule out and rule in? And then, B, how should we think about timing for Medicare coverage? On kind of on the various kind of tests that you’re looking to implement?
Masoud Toloue: Yes, Dan. So, on the Alzheimer’s side, I think what we saw in the guidelines, I would sort of direct folks to the NIAAA guidelines. And there it was very, clear. That test would need an accuracy that’s above 90%. And when we did this, we did two studies. one was the Amsterdam dementia cohort, around 500, individuals were tested. And then we also looked at the BioHermes trial, which was a multicenter, site 17 US clinical sites. And in both, large studies, we were able to achieve accuracies that were above 90%, which is the guideline or the criterion in the draft NIAAA. So, very happy about that. And, I think that’s going to be the case for any sort of test that wants to try to be on the same playing field as PET. And then your second question was on timing of reimbursement. Was that the question?
Dan Brennan: Yeah, yes, yes. It was on Medicare. How do we think the pathway forward for Medicare?
Masoud Toloue: Yeah, so I expect the Medicare path maybe initially will be laid out either by local coverage determination or maybe in the next year or so as this becomes more and more important and in the hands of neurologists and people performing testing, that it becomes potentially a NCD in the future. Hard to say from timing perspective, but we hope that it gets the attention it deserves.
Dan Brennan: Great, thank you, Masoud.
Masoud Toloue: Thanks, Dan.
Operator: Thank you. Our next question comes from Puneet Souda with Leerink Partners. Your line is open.
Puneet Souda: Hey, Masoud. Yeah, thanks for taking the question. So, the first one may be, and I don’t know if this is covered, but, you know, there was a discussion of two-cut assay to drive performance improvement at CTAD. Can you maybe just talk about that, if the P-tau assay is structured that way, and sort of, what’s the performance level that we should expect here. There was also quite a bit of discussion on the performance that would be needed to deliver on P-Tau-217, where obviously Samoa has done well historically. So maybe can you just talk about how Samoa’s position products that are [Technical Difficulty]
Masoud Toloue: Hey, Puneet, can you hear me? You got cut off there at the end, but I got the first part of the question.
Puneet Souda: Yeah, if you could also talk about reference labs competition too, I mean, what do you think about that? Thank you.
Masoud Toloue: Yep, so as I said, we looked at two different sample cohorts, two large sample cohorts. And I think when you start to look at a blood test that’s going to be on the same playing field or could be the diagnostic test, meaning something that’s a rule in or rule out, you’re obviously doing it some comparator, either CSF or PET. The two cutoff approach is incredibly important. So we use the two cutoff approach. It was recommended by the draft NIA guidelines. And it basically establishes a three zone test and reflects low, intermediate, and high risk of amyloid pathology. So samples reading below the cutoff are unlikely to have the pathology. And then samples reading above the upper cutoff are likely to have that pathology.
So I think that’s it. As we move forward, that becomes more and more the type of test that would be used. if you’re not going to be doing imaging or CSF. And then in terms of the sensitivity required, the guidelines, the requirement is above 90% accuracy. Our assay had the sense and spec and accuracy in both cohorts, so that was incredibly promising. And I just want to remind folks that it’s measuring the time of the assay, Ptau-217 effectively in blood, getting the femtogram per milliliter sensitivity, and then doing it in clinical samples, where you’re looking at patients that are in the hospital early stage subjective cognitive decline, mild cognitive decline, Alzheimer’s, dementia, that’s a broad range. And if you want a test that’s going to be able to effectively measure folks in the early stages of cognitive decline or in the future pre-symptoms, you want a test that has the highest sensitivity that’s going to be broad-based for patients at all ends of the spectrum.
And so I think, based on these guidelines and some of the things that, data that we’re seeing, not all tests and not all platforms are going to be able to do that. And we’re happy that the Samoa and the 217 platform will be able to cover the broadest range of patients.
Puneet Souda: Got it. Super helpful. And then just wanted to, you know, clarify. Obviously, you had the launch of 217, but just sort of the timing for the multiplex and sort of how do you think additions to that 217, additional biomarkers with that 217 are required, or do you think 217, given the significance of this biomarker is now? adequate enough for the field?
Masoud Toloue: Good question. There was some of that discussion at the CTAD meeting, and I think one thing I just want to make very clear is that 217 is very important for diagnosis, and that has been well established, based on what I said earlier. But also want to make clear that this is an evolving field where prognosis, staging, differential diagnosis are all going to be important. It’s not one patient comes in, they’re diagnosed and that’s it. There’s treatment monitoring, there’s following on the patient. And what we’re seeing, if you look at the latest clinical trials and the research, it’s going to likely be several multi-marker tests. And the sensitivity required for each of those biomarkers is going to be high. And so having a platform where you have wide bandwidth.
wide sensitivity bandwidth to be able to measure a tau at the same time as you’re measuring a beta or a GFAP or NFL on the same run, same patient sample, is going to be incredibly important. And so, I think you’re right, 217 is the best. the single marker for diagnosis. I think it can be enhanced with multi markers and then staging measurement of a patient over a period of time and the prognosis is likely to be multi marker based.
Puneet Souda: Got it, okay,
Masoud Toloue: Thanks, Puneet. Operator: Thank you. Our next question comes from Kyle Mikson with Canaccord Genuity. Please go ahead.
Kyle Mikson: Yeah, thanks for the follow up guys. So on 2024, if you analyze this fourth quarter guidance, like the fee, the full year revenue for next year, that which is in line with this year’s levels. Obviously, if the macro improves in the, like, you know, this fourth quarter run, it could be kind of conservative, but, you know, it sounds like the rollout of these new SKUs of assays could create some noise and possibly growing pains next year as well. So it’s kind of, there’s a kind of a lot going on. So can you just kind of walk through the main swing factors that could get you to like above or below the double digit growth target for next year? And then maybe any thoughts on cache usage in 2024 as well would be helpful too. Thanks.
