Sienna Cancer Diagnostics Limited (ASX:SDX) CEO, Matthew Hoskin discusses positive Johns Hopkins hTERT test results and the progress the company is making.Jessica Amir: Hello. You're with Jessica Amir for the Finance News Network. Joining me from Sienna Cancer Diagnostics is CEO, Matthew Hoskin. Matthew, welcome back.
Matthew Hoskin: Good to be back, Jessica.
Jessica Amir: For new investors, Matthew, Sienna Cancer Diagnostics is a med tech company with a cancer related biomarker test. Tell us more.
Matthew Hoskin: The company is focused on taking novel, clinically useful tests out of the research laboratories and into routine clinical use. Our first test on the market is an IVD or in vitro diagnostic test for the biomarker called hTERT and that hTERT protein when detected in certain cells within the bladder, so found in urine samples, can give clinically useful information to diagnosing physicians to give an indication of your urothellalcell carcinoma either being present or developing. We know that early detection in cancer can often be all the difference for the patient.
Jessica Amir: Absolutely. Now to the John's Hopkins study, what were the results?
Matthew Hoskin: To put that in practical terms, 31 of the patients within the study cohort had an atypical or an uncertain urine cytology result, but they also had a positive Sienna test for the biomarker hTERT. When those patients were followed up, 15 of them went on to have bladder cancer confirmed by biopsy. Two of them even had a negative initial cystoscopy result. That shows that if hTERT was used in the algorithm for the diagnosing physician to decide whether or not to go on to further testing, that would've been 15 patients that may have had their cancer detected that would otherwise have gone undetected.
Jessica Amir: Where were the study results presented and what was the response?
Matthew Hoskin: They were presented at the United States and Canadian Academy of Pathology meeting, at the annual general meeting. It was actually received very, very well. It got a lot of interest and it generated a lot of sales leads not only from laboratories in the US interested in having a look at the test, but also other laboratories from around the world, which is very encouraging. Very importantly though, the test has since been accepted for peer review publication by a leading cytopathology journal. That's really important to us because we know a lot of laboratories who have been trialing the test have been waiting on peer review published data to really gain comfort with rolling the test out into more routine clinical use.
Jessica Amir: Thanks, Matthew. Now to the roll out in the US and Europe, just remind us about the size of each of those markets and how the roll out is progressing.
Matthew Hoskin: Globally, we estimate that the addressablemarket for the test is in excess of 6 million tests. The United States represents about a quarter of that market so it's certainly an extremely important market for us. That market is looked after by StatLab Medical Products, our exclusive distributor in the United States. They've got a whole team of sales people who are out there promoting the test. There's a very large number of labs to cover and StatLab have gotten very good initial interest from labs, many of whom have started that process of testing and evaluating the test for themselves.
Jessica Amir: How about in Europe?
Matthew Hoskin: So far, we've gotten some very capable distribution partners lined up for Denmark, Sweden and Switzerland, and while those markets may not be as large as some of the other European economies, we know that we'll generate some initial revenues from those and we hope that they'll be a reference point as we expand to other markets throughout Europe.
Jessica Amir: How are you going with appointing a distribution partner or partners in Asia?
Matthew Hoskin: Asia as a market, it's a disparate market in terms of distribution networks and also from a regulatory perspective, but it's an extremely important one to us because it's both large and it's the fastest growing as far as IVD testing. We're initially targeting a subset of those Asian countries based on a range of criteria including the market size and opportunity as well as the ease of regulatory pathway to get into them. We're engaged in a number of discussions with some very promising distribution partners in those countries and we'll continue to work on that particular aspect of our geographical expansion strategy.
Jessica Amir: Matthew, when we last caught up, you mentioned expanding the application of your IVD testing. How's that going?
Matthew Hoskin: The R&D team has made significant progress over the last six months in that strategy. They've secured some access to samples, which is extremely important for the internal R&D work and also they've engaged with some key opinion leader physicians who are interested in performing clinical studies to actually investigate the novel use of the test in those new applications. Now again, a source of samples has been secured and we're hoping in the near future to announce the start of a new clinical trial.
Jessica Amir: Last but not least, Matthew, what's the focus for the next six months and just tell us why you think investors should be adding SDX to their portfolio?
Matthew Hoskin: Look, I think Sienna has a very good mix of risk and reward. As far as other medical technology companies go, we've removed significantly one of the risks that often hampers medical technology companies in that we already have the regulatory and the reimbursement required to enter the market and our product already has initial revenues. That gives us the opportunity to not only grow the revenues and the company in the traditional areas of market penetration in the existing countries where the US is obviously the biggest opportunity there, but also through our geographical expansion program and adding new distributors.
Additionally to that, we've got the opportunity to grow the company through additional applications of the test being applied in new cancer types and then also, through the addition of new technologies into the Sienna pipeline, something that we're very actively working on. Over the next six months, I think we'll see progress in all four of those key strategic growth areas.
Jessica Amir: Matthew Hoskin, looking forward to the next six months. Thanks for the update.
Matthew Hoskin: Thanks for having me, Jessica.
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