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Jayne Shaw Chair of BCAL Diagnostics (ASX:BDX) details the significance of its new blood test for breast cancer, which will be available alongside mammograms at Sydney Breast Clinic later this year. The test aims to enhance early detection, particularly for women with dense breasts or genetic predispositions.
Jayne explains the implementation of their test in partnership with Sydney Breast Clinic, which has been collecting samples for six years. They also have plans to introduce the test in the US, starting with a soft launch and expanding into major states. Both countries will run the test concurrently.
Financially, BCAL Diagnostics (ASX:BDX) is robust with $8.8 million in the bank and an additional $2.5 million expected from R&D tax rebates. Jayne highlights the plans for commercialisation and partnerships with larger labs to scale the test, while acknowledging competition from companies like Exact Sciences and Grail
Full unedited transcript below:
0:00
Well, it's very important because it gives us a site where women can actually go and choose to have a blood test alongside a mammogram. So we're launching the test alongside a mammogram, which has been the standard of care for the early detection of breast cancer for the last 30 years. So yes, ladies can register at Sydney Breast Clinic for a blood test at the end of the year. So it's very exciting. So you say in conjunction with the mammogram. Yeah. So what does your test offer perhaps that would enhance testing for breast cancer. Yeah. So a mammogram has been the standard of care for the last 30 years. However if you have individual risk factors you've got a gene mutation or a predisposition to breast cancer through a family history, or you have dense breasts. Um, about 70% of women who have breast density of CD are more likely to develop breast cancer. They have a mammogram, an ultrasound or a contrast mammogram, or an
0:59
MRI. This blood test will be used alongside a mammogram as another diagnostic tool, I think, to launch a test to replace the existing standard of care for the last 30 years. We're launching it alongside our clinicians preferences, which is alongside a mammogram. And ultimately clinicians will choose, um, you know, whether women need an additional test to a mammogram. So it's another diagnostic tool for the early detection, similar to how the PSA test was launched for men with prostate cancer in 1989. In Australia, it wasn't. The new test just replaced. It was, um, incorporated with other diagnostic tools and then evolved over time.
1:45
So what's the commercialisation process then? Is this where Sydney Breast Clinic comes in? Yeah. So Sydney Breast Clinic is a multidisciplinary breast cancer clinic. The importance of this partnership is that we've been actually collecting samples at that site for the last six years from women who have been having a mammogram. So they've been part of our clinical study programme, as well as 1213 other sites across Australia Westmead, Lifehouse, Monash, Peter Mack and we'll be launching it in parallel with our clinicians as another multi-disciplinary diagnostic test. So it's very exciting
2:25
and I'll see you the same time. You've also established a subsidiary in the US. Why is that?
2:32
It's about market entry into the US. So all our scientific data has to be run in parallel across two continents. So the science that we run in Australia, we run in the US, um, we're having a soft launch in Australia, will, um, expand nationally throughout, particularly the regional areas in Australia. And we're running a dual track, um, market entry into the US at the same time. And we've got our own laboratory over there now, and we'll launch to a clear lab strategy within the US into probably the four largest states in the US market. So it's very exciting. We can run the science, our laboratory closes down Australia, the US starts running over time, access to more samples and diversity. So it gives us a market entry footprint into the US. Where are you at with the regulatory process there? Yeah. So we are entering the market through a clear lab strategy. So we own the laboratory. Um, we are going through
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Nitro accreditation, uh, on Monday. Once we get that assessment, we'll complete our validation studies and we'll be launching the tests in Australia. And then in the US it will be a similar path to market.
3:44
How are your financials looking at the moment. So I think in your latest results, uh, you uh we you're still not in profit. But no, you're close. What are you looking at. So we've got about 8.8 million in the bank as of today, and we've got another 2.5 million, um, through the R&D tax rebate later in the year. So we're well capitalised to launch this test within Australia and the US market. So we're in a good strong position and have to thank our investors for that to date. So so what is your path to profitability once this becomes commercial you launch it and it's the uptake obviously. So at the moment we've got three uh mass specs within our own laboratory. We can run about 20,000 tests on each, uh, on each mass spec. So it's going to be scaling, leveraging within our own laboratory initially. And then particularly in the US, we'll be looking for some commercial partnerships with some of the big, uh,
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commercial laboratory companies who've got the national footprint and infrastructure to provide this test to women everywhere. How unique is this technology? Is anyone else doing this? Yeah. So there are other companies out there. There's one of the company that came out of Canada. They've got a proteomic test, but they're still in the same validation stage as we are. And then you've got the big companies like Exact Sciences and Grail who've got pan cancer tests. So a pan cancer test is where they look for all cancers, but it's not specific to breast cancer. So there's about 4 or 5 competitors at different stages of development.
5:27
I gather you've just been down at the ASX conference there. Um, what sort of interests have you had, particularly from institutional investors? Yeah, I think, um, to date we've had some institutional investment support. Um, I think with the biotech sector, you've got to prove that you've got a product to take to market. Um, and so I think as our market cap continues to increase and improve, we'll get more traction with the institutional investors over time. And also, we've demonstrated that we can take a product to market from R&D into the commercial world and hands off the clinicians.
6:06
Do you perhaps come up against some prejudice in this biotech sector? Because it tends to be, I guess, investors maybe shy away from it because it has binary outcomes, essentially. Absolutely. And you need patient investors. So we were privately funded for ten years, um, by high net worth individuals and people who've been affected by breast cancer. And it was only when our scientific data was at a standard that the clinicians said was acceptable that we went out and raise capital. So you need long term patient investors. It's 14 years to date and we still haven't got the product in the market. So, um, you know, we're very fortunate in Australia that we've got the R&D tax rebate to support companies like this. You've been there for the whole journey. You're the co-founder. Yeah. Talk us through that. What? It's like. um. I mean, obviously it is a long process. We know that given the field you're operating in, um, you where do you
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feel is you're at at the moment just in terms of that confidence that you're close? Well, I'm very excited about it. And it's passion and purpose led. Um, unfortunately, I had a very close friend die in her 30s. Uh, we were all doing the school run together. Told she was, had a long, uh, was misdiagnosed and then died at 35 with twins, aged four. And I just thought that had to be something different. And at that stage, um, there wasn't, uh. Well, there still isn't for women under 40. The number one examination tool is still your hand. You can have an MRI if you can afford it or you have accessibility then. And so, um, I just want women to have access to the test, early diagnosis and improved outcomes. That's the dream. That's the vision. And we're nearly there.