Good catch @Scoonie. There are several breast cancer detection blood tests under development across the world, using a range of different technologies. None, as far as I am aware, have been submitted for regulatory approval. So the $BDX timeline would indicate they are pretty advanced in the field.

While the specificity and sensitivity data appear remarkable based on the benchmarks presented, and the limitations of mammography are well-understood, it is interesting that they have announced the latest results before they have been published in a peer-reviewed journal. What piqued my interest is the subtitle of the graphs on slide 8 "Analysis Via Machine Learning". This indicates that the analysis of the lipids detected or the "finger-print" of the sample is analysed against some library of known positive marker combinatoins - presumably itself a dataset that will grow and improve over time. I would have thought that any regulatory agency would want to see the science behind this thoroughly vetted before giving approval and, again, I would have thought that peer review in a leading journal would be a first step in that process.

I guess that is what is implied in all of the extended timelines that fade off into the future: "clinical valiation studies", "stability studies", "analytical validation studies", "monitoring studies".

I'll put my hand up and say that I don't have experience of the typical pathway for diagnostic test regulatory approval, but with only internal validation and a lot of formal and independent validation ahead of it, I can't help but wonder what the basis of the stated milestones for regualtory filing ("Australia Intended Use defined") are? Are they "expected dates" or "earliest conceivable" dates. There is often a big difference. When do they need to come to market for more cash?

Once the tests are approved and being used commercially, I imagine there will be a period of time where testing is run in parallel with conventional screening, with studies to determine the best pathway for different patients. I think it is only at that time that we would see how quickly the clinical standards shift. Perhaps its will complement mammography. For example, a patient with a high density score gets to take a blood test.

I almost feel foolish writing the above, because the CVs of the team as shown in the presentation are impressive, and I have no doubt they could give me a masterclass on all the above. (Which makes me wish I'd attended the presentation.)

My conclusion is that this is definitely something to monitor. Your general point is well-made, in that the pace and breadth of medical developments is astounding. However, I would caution jumping too quickly to the end game. I'm not selling my $VHT shares tomorrow on the basis of this, but, absolutely, this exemplfies the importance of always monitoring the external environment.

@Strawman could be good to get John Hurrell along? (Shhh...don't tell him a bunch of StrawPeople are holders of $VHT!)

Absolutely @mikebrisy -- I'll throw out a line and see if I can line it up.

@Scoonie, this looks very impressive, but I don't think it will sink VHT.

The most likely scenario is BDX gets adopted for people where imaging is expected to give a poor result.

I am no oncology or surgical expert, but at an expected cost of $350/test, it's not going to replace imaging on a widespread scale, with mammography paying a MBS fee of $96/procedure. The actual amount paid to a radiology practice is 85% of that as almost all mammograms are bulk billed. There is a degree of state funding thrown in as well, but it's not going to add up to anywhere near $350/test.

Blood tests already exist for screening certain types of breast and ovarian cancers, but these are hugely expensive (circa $1200) and only identify a certain type of cancer, so are thus limited as a screening tool.

If the BDX test gets legs, the population health screening guidelines will be rewritten to determine the optimum criteria for who should get what test.

My guess is that it most likely will mean that imaging remains the first screening step for most people, followed by serum screening with BDX (or any other successful serum test) for a small subset of others (e.g., less than 50yo, less than 40yo and family history, ambiguous imaging, or similar)

Obviously, if the cost per test can beat the cost of imaging, you have a different cost benefit public health equation, but there's a big gap between $350 and $84.

If BDX (or a competitor) can get it that low, then that suggests a potential huge gross profit margin of >300%, which isn't something you generally see in diagnostics.

Great post @nerdag. I am curious won’t imaging always be an adjunct not an either or? Would doctors not need to know size and location of tumor e.g to do a lumpectomy vs full mastectomy and to understand whether lymph node removal was required.

@Nnyck777, imaging is always going to be needed.

For clinical correlation, I've always understood that ultrasound is preferred (any radiologists or breast surgeons here can correct me if I am wrong), so VHT is out of that equation.

For evaluating spread and staging, I've always understood it to involve CT scanning with contrast.

One further observation about the timing of the $BDX "Investor Education and Awareness Webinar":

Cash at 30-June $3.2m. Cash burn rate about $2m per quarter. Expect this to increase as they move into commercialisation and regulatory filing. They've done a good job in making the $10m raised in the IPO keep them going for 2 years, and the progress to this stage has been rapid.

Either they need a partnership deal very soon, or they need to raise capital, or be acquired. Something has to happen in the next few months.

You need to take a step back from these testing modalities and think about how they are calculated. Screening for disease has two competing arms, which is slightly cynical of me to say but consider it like this. The accuracy and benefit of the test, is competing against the interests of the government in wanting to subsidise them.

What this eventually comes down to, is cut off limits. For example, screening for bowel cancer is nationally subsidised, is cheap, very sensitive, yet not very specific, as lots of things can cause blood in stool, such as a minor haemorrhoid. However, despite this patients with a positive result are referred for a colonoscopy because the disease is so so so treatable if caught early. So there is a huge survivor benefit

But we stop screening for it at 74 years of age because the benefit of anything we found at that age, would be less than the survival benefit of treating whatever is found when compared to standard life expectancy.

On the other hand you could have VERY specific tests, that are not very sensitive, such as various blood tests for autoimmune diseases. You conduct the blood test and if they come back positive, that person (near) absolutely has the disease, yet a negative result doesn't exclude disease.

A good screening test has some characteristics, it needs to be tolerable. If a patient wont undergo the testing, then it is useless. Examples of this might include transvaginal ultrasound for ovarian cancers, which very large, randomised and double blinded studies have demonstrated that women will undergo routinely, because ovarian cancer is nasty, hard to find and harder to treat. . Yet despite these large studies, we do not have routine screening for ovarian cancer as the studies demonstrated that despite doing serial ultrasounds, blood tests for ovarian tumour markers and follow ups, there was no survivor benefits to the whole process. So this remains an unmet need within health.

A good screening test needs to be applicable to a population. So a blood test fits this descriptor.

A good screening test needs to be accessible, this is where cost comes in, as does the level of subsidy a government is willing to give.

The level of subsidy that a government will give really comes down to, what do they get out of it. They will ask, does the cost of administering this test to a population, equate to equal or less than the cost of treating it now or later. . So they would need to compare any new test, against current test. AKA mammography.

Specifically in regards to the numbers given. Sensitivity and specificity are inverse relationships. So its really hard to define a perfect test. But at 85% specific, some 15% of patients told they have a negative test, actually could have it.... not good. So from a screening point of view, I would personally like to visualise the tissue. After all, a lump is a lump.

Lastly, if folks care to look into this. This below table is how these things are calculated. A quick google of 'the perfect screening test' or similar will give more than a days worth of reading.

@TycoonTerry, a perfect test is both sensitive (high true positive) and specific (high true negative), and there are trade offs in any assessment of suitability for a screener.

You are correct, testing needs to be tolerable - some would refuse a mammogram but consent to a blood test, and vice versa. Neither are particularly invasive or objectionable (with the tolerability advantage in favour of the blood test I suspect), so I doubt that makes a material difference to the cost calculation here.

For a health budget, the question is not 'is the new test the better test'? The question is going to be is the newer test going to pick up more true positives that would be missed by the existing test such that it reduces overall morbidity or mortality and cost burden to the population, relative to the cost of the new test.

That is a much more complicated calculation than true positive/true negative rate.

(Note - edits for clarity and brevity).

Hi @nerdag and @TycoonTerry mammograms are still valuable as screeners due to cost plus given density scores and AI detectors could still work to funnel to blood tests + ultrasound and biopsy and then possibly to CT/ MRI.

I think it is very premature and inaccurate to sell due to BDX.

I am yet to be convinced this will transplant Volpara.

@Nnyck777, I've doubled my position in VHT IRL (pre results) and am holding.

I don't believe BDX or any serum test is going to replace XR for this purpose unless it can be done at significantly less cost and with comparable or better sensitivity/specificity.

@Nnyck777 @TycoonTerry @nerdag Totally agree that $BDX story has no bearing on my view of value of $VHT. If Terri continues to execute, I fully expect to be adding to my position over time.

It has been great reading some of the perspectives shared on this thread. It is good to be scanning the horizon and always thinking about risks and opportunities. But we’d never hold anything if we jumped at every shadow.

The only transacting I did today was that my second tranche of $RMD finally went through. Yay!