Lishan Aklog, Lucid Diagnostics - Studio Interview | LSI USA '24

Lishan Aklog  0:00  
I'm Dr Lishan Aklog. I'm the Chairman and CEO of lucid diagnostics. Lucid is a cancer prevention a company that has technologies that are groundbreaking and able to detect esophageal pre cancer as a method to decrease the incidence of esophageal cancer, the three most deadly cancers, pancreatic cancer, esophageal cancer and liver cancer. Actually, more people die of those three cancers that we rarely speak about than breast and colon cancer combined, and that's because those cancers we've had appropriate early detection programs that have cut down on the mortality rates over the last 30 years by about 50% those three deadly cancers, pancreatic, esophageal and liver have not benefited from those types of technologies that allow early detection, and that's now changed for one of the three. So esophageal cancer now there is technology similar to the technologies that are available for other cancers that can detect a precancerous condition. So there's technology now available in the form of a molecular diagnostic test called E cigard that uses a office based two minute cell collection tool where you collect cells on Office no anesthesia, and you can detect with a really unprecedented degrees of accuracy even the earliest stages of esophageal esophageal pre cancer. So you can intervene by doing surveillance and intervening prior to developing cancer and prevent what are, what are entirely preventable tragic deaths that happen about 16,000 times a year. The tool, the cell collection tool, is a very clever technology that's an alternative to an endoscopy. An endoscopy is a very pretty invasive thing. You go in two people have to take the day off of work. It's under anesthesia, sedation, and you have to swallow this big camera, and they take biopsies and so forth. So as an alternative to that, we have a device called eso check, which has a pill sized vitamin pill sized capsule. It's got a piece of silicone, kind of spaghetti, a little soft piece of silicone that it's tethered to. And that capsule has at the end of it a balloon, a very soft silicone balloon with some soft ridges on it. What that allows you to do is to swallow the capsule, just like you would be swallowing a pill, no anesthesia, no sedation. In an office setting are we have nurses and nurse practitioners who perform this 1000s of times a quarter, without any cameras, without any X rays, you're actually getting the cells from exactly where you need to get them anatomically targeted, protected sample, where these abnormalities, these very subtle abnormalities of the earliest stages of the pre cancer, occur. And that whole thing takes two minutes, and it's become very, very simple, and it's actually now recommended in the guidelines by the gastroenterology societies as as an acceptable equivalent alternative to endoscopy. So that's part one. You get the cells, and then then where the magic really happens from a scientific point of view. And really the cutting edge here is next generation sequencing of the DNA in the cells. The DNA is a sample sent to a central laboratory. The DNA is extracted, and using these tools, where you can sequence very targeted areas on two genes, we can determine with a very high degree of accuracy if any of these early precancerous changes have occurred as well as cancer. So anything along the spectrum from early pre cancer all the way to cancer can be detected with a very high negative predictive value, so very, very low false negative rates. And so based on the results of that test, which come back in about a week, the physician can make the appropriate recommendations 30 million Americans today by existing, established american college of gastroenterology guidelines should be tested and are not only about 5% of them are being tested. Our test has a Medicare price of about $2,000 just under $2,000 so this is a huge market opportunity right here in the US, and so our small team is focused on starting to capture some of that market opportunity. Here on the commercialization side, we now have a very well established path. We can talk to physicians. It's not that hard to get it's very straightforward to explain to physicians. There's esophageal cancer, there's heartburn, there's a relationship between the two of them. There's an alternative to endoscopy that could be done in two minutes. All of that goes really well. We've established this whole model around how we have nurse practitioners who can co locate at physician offices and come, let's say, once a week or once a month. We call her a satellite testing program, similar to like having a phlebotomist in a in a physician's office. All of those elements are well established. We know how to even do direct to consumer marketing, where we have marketing collateral that teaches patients on how to understand this relationship. And so all of that is humming. What we're down to is that last mile of translating this market opportunity, test volume, test volume growth, claims submissions into reliable reimbursement, which is a really has two elements to it. One of them is seeking medical policy coverage, positive medical policy coverage from public from private payers, as well as Medicare. A big milestone for us coming up this year is we're in the final stages of having all the data that we need to submit for Medicare reimbursement under an existing final. And effective local coverage determination. So that's going to be a big, a big event for us. And then there's a whole nother world here, which is direct contracting, including diagnostic tests. Again, this is not something that we commonly think about with medical devices, let's say, but for a test, it's actually increasingly common to include a diagnostic test, like a cancer pre cancer screening test, within a Health and Wellness Benefit Program so completely separate from the traditional insurance submitted claims, and we're just getting started on that. It's extremely exciting, because whether it's a self employed, a self insured entity like a union or an actual employer, you know, they're they care about their their members, or their or their employees, and the opportunity to take a to take a their Health and Wellness Benefit Program, and not just include, you know, weight loss programs or nutrition or the kind of tip of smoking cessation, typical things, but an actual opportunity to provide testing for for their employees or for their participants is something that's exciting, and we're gearing up to to really push hard on that this year. So those are the two big areas. So.