Amro Albanna ( 00:09 ): So Steve, we'll just wait a couple, few seconds here because for some reason, we need to wait to make sure that the whole thing is being recorded. I'm seeing people joining. Steve Varvel, Director

Amro Albanna (00:09):

So Steve, we'll just wait a couple, few seconds here because for some

reason, we need to wait to make sure that the whole thing is being recorded. I'm seeing people joining.

Steve Varvel, Director of Clinical Trials, Pearsanta

Amro Albanna (00:21):

We have few attendees. I'm just waiting few seconds here. More and

more people are joining.

Welcome, everybody. Thank you for joining.

Let's see, I think I see everyone has already joined.

Steve, welcome. How are you doing today?

Steve Varvel, Director of Clinical Trials, Pearsanta

Good morning, Amro. I'm doing great, thanks.

Amro Albanna (00:41):

Wonderful. Steve, thanks for joining us.

And folks, obviously I continue to repeat this every time because we

never know who's joining for the first time. My name is Amro Albanna. I am the Co-founder, Chairman, and CEO of Aditxt. Again, thank you

for joining. Today I asked Steve, and to his credit, it was a last-minute request. I thought it would be wonderful for Steve to come and

join us to talk about the endometriosis announcement that we just made.

Before we jump in, Steve, why don't you just quick background introduction,

so everybody knows who you are, where you're based, and we'll take it from there.

Steve Varvel, Director of Clinical Trials, Pearsanta (01:18):

Sure. Well, my name's Steve Varvel. I'm the Director of Clinical Trials

here at Pearsanta in Richmond, Virginia. Been with a number of diagnostic laboratories doing clinical research over the years and very

excited about our Adductomics tests that are in the pipeline and that we're aggressively pushing forward. Happy to be here.

Amro Albanna (01:41):

Steve, we met what? more than now four years ago, right?

Steve Varvel, Director of Clinical Trials, Pearsanta

Amro Albanna (01:48):

I think so. It was right around COVID. Actually, we acquired the assets

of Salveo out of Richmond, Virginia. Steve, one of the originals over there, and he continued with us. So again, thank you, Steve. You've

certainly been around, and you've been pushing forward. And now it's under the umbrella of Pearsanta.

Just to provide this point of view, Pearsanta is one of Aditxt's subsidiaries,

focused on early disease detection. I think we can all understand, the better or the sooner, the better when it comes to disease detection.

That's a general statement. It makes sense, especially when it comes to cancer and other serious diseases. So the whole mission of Pearsanta

is early disease detection, and eventually, Steve, eventually we could get into prevention. But that's another topic for another day.

Why don't we talk about endometriosis, which is part of the Mitomic

platform and what that announcement was all about, as far as receiving IRB approval to begin clinical studies.

Steve Varvel, Director of Clinical Trials, Pearsanta (02:53):

Sure. No, no, happy to. We have a number of tests in the pipeline based

on this Mitomic technology, identifying disruptions in mitochondrial DNA that are signatures of certain stressors on cells. It has a lot

of application in early cancers, but also endometriosis, while not a cancer, it's also an example where there are cells where they shouldn't

be under specific stressors. And that leaves a profile on the damaged mitochondrial DNA that we can pick up in a blood test.

This test was furthest along when we acquired it, so we're launching

with this one first. We've done the tech transfer from the UK lab, where we got this, and have been doing the development here in Richmond

and are now ready to complete the analytic validation and the clinical validation so we can launch this test as an LDT as soon as possible.

Amro Albanna (03:54):

Steve, sorry to interrupt you right now, just where we can actually

begin with the issue. Endometriosis, obviously, women-related disease, and can you at least help us understand what the difficulty is

right now? It is a challenge, but why do we need a test? What is happening right now in the industry, where we cannot detect it? Is it

invasive? Is it too late? Can you just help us understand what that issue is and potentially what the size of the challenge is?

Steve Varvel, Director of Clinical Trials, Pearsanta (04:30):

Oh, absolutely. Endometriosis is a huge issue in women's health. It

generally presents as pelvic pain. It can get very severe and can lead to infertility. 10 to 20% of women of childbearing age experiences,

so it's very widespread and touches... Just about everybody knows someone that's gone through this.

Unfortunately, there are no good tests for it. As it gets more progressed,

you can see some of this with imaging, but the real way to diagnose this is with a laparoscopic surgery, where you go in and actually

confirm it. Since nobody wants to jump to that first because that's kind of a severe procedure, so what happens is that women end up suffering

for years. It can take 5 to 10 years on average for a woman who first presents with symptoms to actually receive a diagnosis.

So an easy blood test, that can go right in upfront as someone's experiencing

symptoms, whether it's painful periods or pretty common sets of symptoms, instead of not doing much about it or taking a wait and see

attitude, we can get a test and get them on the right diagnostic pathway as early as possible, when it's much easier to manage. As with

most things, the earlier you can catch this, the more chance you have of avoiding.

Amro Albanna (05:53):

Great. Our goal right now is to truly present and offer a non-invasive

blood test that could, and I will say could, just to repeat this, it's not commercial, we still have to do certain validation, we still

have to comply with certain rules until we can actually claim it is commercial. It is not yet. Our goal is to advance that validation,

clinical studies, whatever is required, and if we're successful, we can provide a commercial solution for women, non-invasive blood sample-type

test to detect endometriosis. Is that the value proposition?

Steve Varvel, Director of Clinical Trials, Pearsanta (06:30):

Absolutely. The way this would work, particularly early on, as you

say, assuming the test works, this would be placed in the diagnostic path, where it could be early on. As one first starts to experience

symptoms, we could get a blood test done very quickly, and if positive, that could help them decide to go ahead and do the laparoscopy

to get the official diagnosis or not. It'll really help the physicians and gynecologists make decisions about the treatment of the patients

Amro Albanna (07:09):

Great. All right, I'll jump in, Steve, on one, to dig into the technology

a little bit because I think it's pretty fascinating when we're talking about mitochondrial DNA, DNA-based diagnostics and eventually

therapeutics is the future, I believe and we believe. So we'll dig into the technology here in a second, and then I want to talk about

the Richmond, Virginia facility where you at to share with our, frankly, the current audience and people that will view this later on

to understand that it's not just an innovation. It's an infrastructure behind it.

Steve Varvel, Director of Clinical Trials, Pearsanta (07:45):

Amro Albanna (07:46):

But before I do that, I want to mention something about Q&A. This

time around, we're going to try something with questions and answers. If there are questions, we're willing to take it, obviously, live.

You can go at the bottom, you can hit the Q&A button, and Steve, myself, and our team will see the question. I strongly recommend

and encourage questions. Tough, easy, it doesn't matter. The reason we're doing this is to truly socialize the concept of innovation.

Innovation is not a straight path. It's not always rosy. Mistakes will

happen, and we want to show our stakeholders and future stakeholders what's going right, what's tough, what's a challenge. That's why

we want to make sure that we provide this forum to hear from us, to also see people behind the scene, beyond myself, like Steve and other

team members that you've seen in the past. I encourage you to put Q&A, and again, including some of our team members, which I see

joining us here. So that said, again I'll just monitor the Q&A window. And we'll take it from there.

Steve, we talked about the challenge. We talked about what we view

as a non-invasive, timely solution for detection of endometriosis. Now let's talk a little bit about the technology. We're talking about

mitochondrial DNA. Can you help not only medical folks, what is mitochondrial DNA? Why are we focusing on using mitochondrial DNA? Do

we think it helps us with precision and timely diagnosis? And I'll leave it to you from there.

Steve Varvel, Director of Clinical Trials, Pearsanta (09:37):

Sure. No, no. Mitochondrial DNA is such a fascinating area, and it's

not one that I had a big background in until we started looking at this technology. But everyone's kind of familiar with DNA testing and

knows the cartoon where there's one copy of DNA in the nucleus of every cell, that control blueprint for all the proteins.

But the mitochondria, little organelles inside the cell, there could

be hundreds or thousands of mitochondria inside each cell, are just really key for making power for the cell and are the center of a lot