Experiment size is literally N=21, with 4 healthy participants, 3 in-situ breast cancers, and 14 invasive breast cancers.
N=21 might as well be useless in my opinion. You can't draw any meaningful conclusions about statistical power of this test; if your priors were 10% for breast cancer, after taking this test, your posterior probably remains unchanged.
You can absolutely draw conclusions about the statistical power of the test. That’s what statistics is for.
If this sample data is randomly sampled it looks like it will be a fairly high precision test for invasive cancers, with room for false negatives. You would have had to have gotten very unlucky to see such a difference in distributions even on a small sample like this. But sure, let’s get more samples.
It's still a nonzero sample size, and if anything, says two things:
(a) We should do more tests to increase N
(b) If a $5 device tests you positive, maybe you should go get checked out for $5000 or whatever the doctors charge you (because insurance often only pays AFTER "shit happens" and often does not pay to test "whether shit might happen"), that you wouldn't have thought of doing otherwise.
> Table I shows the median and the range of digital readings by disease status and overall p-value using the Kruskal–Wallis test to examine if there exist statistically significant distinctions among two or more groups. The overall p-value is significant while the value for HER2 is 0.002, which show the probability of false-positive detection. This indicates that this sensor technology is an efficient way to detect HER2 biomarkers in saliva.
> ... In Fig. 5, the test results for detecting CA15-3 of the human samples are displayed. The digital reading decreases from the healthy group to the invasive breast cancer group, indicating an increase in CA15-3 concentration. The median, the range by disease status, and overall p-values analyzed with the Kruskal–Wallis test for the CA15-3 test are listed in Table I. The overall p-value for CA15-3 is 0.005, indicating that this device provides an efficient way to detect the salivary biomarkers related to breast cancer.
I appreciate the links but I think this actually misses the point. The novelty isn't in diagnosis of cancer but in sensitivity/cost-efficacy in detection of known biomarkers for breast cancer (and associated risks of recurrence, etc). I'm not familiar with how common ELISA-based HER2 testing takes place, but it seems like it has some impact on drug decisions[^1].
In terms of applicability, it depends on whether or not ELISA is in fact the current standard of care, but it could be useful in low-resource settings where you don't have lab personnel trained to carry out those assays, and drug choice is also restricted by limited availability.
Additionally, there's a point-of-care argument as well. Since breast cancer does benefit from early detection, I can see a future in which biomarker testing is a more regular thing, and high saliva concentrations are flagged. At the very least as something worth bringing up at one's next appointment or wtv.
Figures 3 and 5 from the paper (https://pubs.aip.org/avs/jvb/article/42/2/023202/3262988/Hig...) have overlap between all the groups. The same measured output could have come from any of the non-cancer, or known-cancer, participants. While the means of these groups look nicely separable, that overlap means there will be significant false positives or false negatives. So I'd label the studyfinds headline of this being 'accurate' to be false.
Not at all. The model is quite accurate. In fact, with the distribution of samples that they have a model that predicts all cases as having cancer would also be very accurate. It would get 17/21 predictions right. The model lacks precision. I suspect that even with a fairly high cut off point the model would still produce a bevvy of false positive predictions due to that. It might still be useful as a screening step if they can increase the sensitivity further, but you would still rely upon further tests to get a true diagnosis.
>> HER2 and/or CA15-3 in serum are essential biomarkers used in breast cancer diagnosis.
This is WRONG, it is used as an indicator, NOT a diagnosis. In fact, I have personal experience that CA15-3 is not always in indicator of anything. You first measure a baseline, and use it for reference.
Also there's no HER2 expression in TNBC.
Can this be used for possible early detection? Maybe, but it will not be an exact science.
Thin films grown in vacuums are how you get graphene layers and FETs that appear to be the basis of the technology here. Someone with a vacuum deposition system would be the prime candidate to develop a custom thin film to target adsorption of the molecules that they're trying to sense.
Someone has to actually commercialize this and get it approved and it will cost far more than $5. As part of that they have to demonstrate that it is, ya know, useful (vs existing methods).
The PCB picture above the words "...The printed circuit board used in the saliva-based biosensor,..." makes me think the article is a scam. As a electronics engineer the word labels seem to be not especially relevant to the invention. Who makes boards with lots DIP chips?
The biosensor, a collaborative development by the University of Florida and National Yang Ming Chiao Tung University in Taiwan, employs paper test strips coated with specific antibodies. These antibodies interact with cancer biomarkers targeted in the test. Upon placing a drop of saliva on the strip, electrical pulses are sent to contact points on the biosensor device. This process leads to the binding of biomarkers to antibodies, resulting in a measurable change in the output signal. This change is then converted into digital data, indicating the biomarker’s presence.
It tests for biomarkers in the saliva. Possibly not outright crazy charlatan territory.
Could certainly use a larger sample size though, especially given that one of its bragging points is "fast and cheap!"
As a non-invasive diagnostic equipment, let us say it is akin to a pregnancy test, or a creatine in urine test. That puts it in Class 1, and may be exempt from a lot of the hoops a medicine would go through.
There are a little over 6,100 hospitals in the US at any given time. That means roughly $30,000 in cost to produce to provide every hospital with one, using the cheapest of cheapest parts. Presumably, you'd want higher end components and things like a shell casing to protect from spills, static, etc. maybe the cost is $120k.
You could sell these for $100 each, and maybe make $5 million. That's a decent amount of money for a tiny business, but a pittance for even a small business that needs to pay salaries, lawyers, etc.
In reality, they'd probably go for much more- let's say $10k each, plus $100 for each test strip. Still easily in range for the budget of most US hospitals.
The real question is, if breast cancer is suspected, is this test any better than imaging using equipment the hospital already has?
Can it detect all types, or the degree that it is progressing?
I suspect the utility in a clinical setting is not high enough to really change clinical practices any.
Usually with medical innovations, the idea is patented and the product is sold well above cost of production. e.g. this $5 device could be sold for $100 each... large profit margin.
If there is no patent, and no in-place infrastructure already producing the device, then yes, it's unlikely to see rapid scale up by manufacturers.
Though if it's really that cheap to produce, I'm sure it will come onto market in some form (whether through charitable foundations or otherwise). All assuming that the device is actually as efficacious as the study implies (with a small sample size).
> employs paper test strips coated with specific antibodies. These antibodies interact with cancer biomarkers [from] a drop of saliva
> “[...] cost-effective, with the test strip costing just a few cents and the reusable circuit board priced at $5,” Wan says.
That is cool: the 5$ isn't even the cost of the test, it's the one-time cost of your lab equipment. Of course, per sibling comments, the efficacy has yet to be seen, but even a few percent more early detections due to frequent testing would be a win
"but even a few percent more early detections due to frequent testing would be a win"
This is not the current medical thought on early screenings for various cancers. It used to be and I was confused about it until very recently. Indeed the medical community is still wrestling with the issue of screening harms. The consensus is shifting that screening should only be done if there is an existing condition or symptom or family history.
Using the performance in the paper, the false positive rate means the current test in clinically useless (due to harm from screening and follow-up). Refining the test requires improving the selection of biomarkers and antibodies, not the hardware (which looks great).
No offense, but as someone that makes hardware devices, that hardware does not look great. It looks the very opposite of great.
Through hole DIP array? This is a prototype and it makes me skeptical of the whole thing. There is nothing a single $5 FPGA couldn’t do. So why not start there? I suspect because the people that made this doesn’t know electronics or programming well - but then also didn’t find someone that did.
This was put together the way long way, and it’s strange to me.
The publication is linked in the article [0]. Even if it's only for HER2 patients, even if it's only useful as a first-pass test, this is still great news.
The experimental design seems very small scale though. 17 cancer positive samples (of which only 1 was HER2 positive), 4 control. Since the strips are focused on HER2 detection I read this as "in 1 out of 1 samples, our test detected HER2 overexpression" but maybe I misread it.
I could not assess the validity of this paper if my life depended on it.
But this is what I do know: Given that the University of Florida is a public institution and the governor of the state is anti-science and promotes anti-science policies and practices, my immediate reaction to this paper’s news is negative. Reasonable? Probably not. I can’t be the only one who would react in this way.
This matters for two reasons. First, each of us has limited time and capacity to care about things, to investigate them more. Second, if we don’t recognize our biases, we may ignore important and useful information.
1) These are not clinical biomarkers used for detection of cancer now, and in fact, they are known NOT to be clinical biomarkers useful for detecting cancer.
2) This is a publication focusing on the device/method, not the clinical application. It is published in a journal of vacuum science, not a cancer biology or medical journal.
3) There are several inaccurate things in the paper, one being that they state that current technology requires 1-2 weeks to measure either biomarker. Wrong, clinical tests exist today that can perform those immunoassays in minutes on large automated analyzers.
4) This isn't fraud, it's just a really typically overhyped report of a novel device/meausrement strategy (and it's not that novel) that targets a biomarker that has a role in cancer, and then some mass media picks it up and says that they have "the test for cancer". This happens all the time.
5) This should maybe be considered a proof of concept about the electronics of their detection strategy, since the immunoassay component is known (immunoassays to both biomarkers are not only published, but commercialized) and the clinical use of the biomarkers is not at all diagnostic for cancer or useful for screening.
Better reference would be an ELISA test (which is actually brought up as the reference in the paper)[^1]. That seems to also run about $5 per kit per antigen[^2]. However this device seems to only require the test strip to be replaced, whereas you can only run ELISA once per strip/reagents. Also note that ELISA is harder to run so you have personnel costs and also this device claims higher sensitivity.
[+] [-] e63f67dd-065b|2 years ago|reply
Actual publication: https://pubs.aip.org/avs/jvb/article/42/2/023202/3262988/Hig...
Experiment size is literally N=21, with 4 healthy participants, 3 in-situ breast cancers, and 14 invasive breast cancers.
N=21 might as well be useless in my opinion. You can't draw any meaningful conclusions about statistical power of this test; if your priors were 10% for breast cancer, after taking this test, your posterior probably remains unchanged.
[+] [-] jncfhnb|2 years ago|reply
If this sample data is randomly sampled it looks like it will be a fairly high precision test for invasive cancers, with room for false negatives. You would have had to have gotten very unlucky to see such a difference in distributions even on a small sample like this. But sure, let’s get more samples.
[+] [-] dheera|2 years ago|reply
(a) We should do more tests to increase N
(b) If a $5 device tests you positive, maybe you should go get checked out for $5000 or whatever the doctors charge you (because insurance often only pays AFTER "shit happens" and often does not pay to test "whether shit might happen"), that you wouldn't have thought of doing otherwise.
[+] [-] neuronexmachina|2 years ago|reply
> ... In Fig. 5, the test results for detecting CA15-3 of the human samples are displayed. The digital reading decreases from the healthy group to the invasive breast cancer group, indicating an increase in CA15-3 concentration. The median, the range by disease status, and overall p-values analyzed with the Kruskal–Wallis test for the CA15-3 test are listed in Table I. The overall p-value for CA15-3 is 0.005, indicating that this device provides an efficient way to detect the salivary biomarkers related to breast cancer.
[+] [-] fuhrtf|2 years ago|reply
[+] [-] causal|2 years ago|reply
[+] [-] unknown|2 years ago|reply
[deleted]
[+] [-] pvaldes|2 years ago|reply
The new Theranos is here again
[+] [-] unknown|2 years ago|reply
[deleted]
[+] [-] lofatdairy|2 years ago|reply
In terms of applicability, it depends on whether or not ELISA is in fact the current standard of care, but it could be useful in low-resource settings where you don't have lab personnel trained to carry out those assays, and drug choice is also restricted by limited availability.
Additionally, there's a point-of-care argument as well. Since breast cancer does benefit from early detection, I can see a future in which biomarker testing is a more regular thing, and high saliva concentrations are flagged. At the very least as something worth bringing up at one's next appointment or wtv.
[^1]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7033231/
[+] [-] redder23|2 years ago|reply
[+] [-] iandanforth|2 years ago|reply
[+] [-] ImageXav|2 years ago|reply
[+] [-] adamredwoods|2 years ago|reply
This is WRONG, it is used as an indicator, NOT a diagnosis. In fact, I have personal experience that CA15-3 is not always in indicator of anything. You first measure a baseline, and use it for reference.
Also there's no HER2 expression in TNBC.
Can this be used for possible early detection? Maybe, but it will not be an exact science.
[+] [-] andyjohnson0|2 years ago|reply
Discusses sensitivity but not accuracy or rates of false positive/negative.
[+] [-] masto|2 years ago|reply
and then in 2022 for detecting oral cancer: https://pubs.aip.org/avs/jvb/article/41/1/013201/2866658/Hig...
[+] [-] zacharyvoase|2 years ago|reply
Dare I ask why?
[+] [-] rainbowzootsuit|2 years ago|reply
[+] [-] moi2388|2 years ago|reply
[+] [-] loeg|2 years ago|reply
[+] [-] asdefghyk|2 years ago|reply
[+] [-] SV_BubbleTime|2 years ago|reply
I mean… even if we were talking some special hardware, that’s still PLC territory.
My reading was this isn’t $5, but could be made to be $5.
This is clearly a prototype.
[+] [-] DoreenMichele|2 years ago|reply
It tests for biomarkers in the saliva. Possibly not outright crazy charlatan territory.
Could certainly use a larger sample size though, especially given that one of its bragging points is "fast and cheap!"
[+] [-] iwontberude|2 years ago|reply
[+] [-] deweller|2 years ago|reply
I'm guessing it is expensive to jump through all of the hoops. Without a patent, why would a company pay for this?
[+] [-] zdragnar|2 years ago|reply
There are a little over 6,100 hospitals in the US at any given time. That means roughly $30,000 in cost to produce to provide every hospital with one, using the cheapest of cheapest parts. Presumably, you'd want higher end components and things like a shell casing to protect from spills, static, etc. maybe the cost is $120k.
You could sell these for $100 each, and maybe make $5 million. That's a decent amount of money for a tiny business, but a pittance for even a small business that needs to pay salaries, lawyers, etc.
In reality, they'd probably go for much more- let's say $10k each, plus $100 for each test strip. Still easily in range for the budget of most US hospitals.
The real question is, if breast cancer is suspected, is this test any better than imaging using equipment the hospital already has?
Can it detect all types, or the degree that it is progressing?
I suspect the utility in a clinical setting is not high enough to really change clinical practices any.
[+] [-] adam_arthur|2 years ago|reply
If there is no patent, and no in-place infrastructure already producing the device, then yes, it's unlikely to see rapid scale up by manufacturers.
Though if it's really that cheap to produce, I'm sure it will come onto market in some form (whether through charitable foundations or otherwise). All assuming that the device is actually as efficacious as the study implies (with a small sample size).
[+] [-] unknown|2 years ago|reply
[deleted]
[+] [-] Aachen|2 years ago|reply
> “[...] cost-effective, with the test strip costing just a few cents and the reusable circuit board priced at $5,” Wan says.
That is cool: the 5$ isn't even the cost of the test, it's the one-time cost of your lab equipment. Of course, per sibling comments, the efficacy has yet to be seen, but even a few percent more early detections due to frequent testing would be a win
[+] [-] iamthepieman|2 years ago|reply
This is not the current medical thought on early screenings for various cancers. It used to be and I was confused about it until very recently. Indeed the medical community is still wrestling with the issue of screening harms. The consensus is shifting that screening should only be done if there is an existing condition or symptom or family history.
https://www.cancer.gov/news-events/cancer-currents-blog/2022...
[+] [-] amelius|2 years ago|reply
[+] [-] soco|2 years ago|reply
[+] [-] biomcgary|2 years ago|reply
[+] [-] SV_BubbleTime|2 years ago|reply
Through hole DIP array? This is a prototype and it makes me skeptical of the whole thing. There is nothing a single $5 FPGA couldn’t do. So why not start there? I suspect because the people that made this doesn’t know electronics or programming well - but then also didn’t find someone that did.
This was put together the way long way, and it’s strange to me.
[+] [-] andrew_eu|2 years ago|reply
The experimental design seems very small scale though. 17 cancer positive samples (of which only 1 was HER2 positive), 4 control. Since the strips are focused on HER2 detection I read this as "in 1 out of 1 samples, our test detected HER2 overexpression" but maybe I misread it.
[0] https://pubs.aip.org/avs/jvb/article/42/2/023202/3262988/Hig...
[+] [-] susiecambria|2 years ago|reply
But this is what I do know: Given that the University of Florida is a public institution and the governor of the state is anti-science and promotes anti-science policies and practices, my immediate reaction to this paper’s news is negative. Reasonable? Probably not. I can’t be the only one who would react in this way.
This matters for two reasons. First, each of us has limited time and capacity to care about things, to investigate them more. Second, if we don’t recognize our biases, we may ignore important and useful information.
[+] [-] F51user|2 years ago|reply
1) These are not clinical biomarkers used for detection of cancer now, and in fact, they are known NOT to be clinical biomarkers useful for detecting cancer. 2) This is a publication focusing on the device/method, not the clinical application. It is published in a journal of vacuum science, not a cancer biology or medical journal. 3) There are several inaccurate things in the paper, one being that they state that current technology requires 1-2 weeks to measure either biomarker. Wrong, clinical tests exist today that can perform those immunoassays in minutes on large automated analyzers. 4) This isn't fraud, it's just a really typically overhyped report of a novel device/meausrement strategy (and it's not that novel) that targets a biomarker that has a role in cancer, and then some mass media picks it up and says that they have "the test for cancer". This happens all the time. 5) This should maybe be considered a proof of concept about the electronics of their detection strategy, since the immunoassay component is known (immunoassays to both biomarkers are not only published, but commercialized) and the clinical use of the biomarkers is not at all diagnostic for cancer or useful for screening.
[+] [-] yakito|2 years ago|reply
An MRI machine cost arounds $350.000 on average. https://www.blockimaging.com
[+] [-] ImageXav|2 years ago|reply
Also, diagnosis would typically be done using a mammography. The cost of such a scan is lower - around $100[0].
[0]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4142190/
[+] [-] lofatdairy|2 years ago|reply
[^1]: https://pubs.aip.org/avs/jvb/article/42/2/023202/3262988/Hig...
[^2]: https://www.thermofisher.com/elisa/product/ErbB2-HER2-Human-..., note that I didn't shop around for necessarily the best prices.
[+] [-] aeyes|2 years ago|reply
[+] [-] alhirzel|2 years ago|reply
[+] [-] SV_BubbleTime|2 years ago|reply
The thirty through hole parts made me the think the same thing.
[+] [-] moi2388|2 years ago|reply