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Japanese startup test kit shows promise in early cancer detection

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A urine-based cancer risk screening kit developed by a Japanese startup is showing promise in detecting cancer at the earliest stage using non-invasive means.

The test kit from Craif Inc, a spin-off from Nagoya University founded in 2018, can also be used to assess simultaneously whether a person is at risk from any of up to seven types of cancer.

The product, which does not require a blood test, was able to detect changes in pre-malignant cells among residents of Hokkaido towns in northern Japan to whom the company distributed 100 sets of the "miSignal" test kit free of charge in the year through March 2025.

"We were able to detect and treat cancer that was difficult to find by X-ray," said Tatsuya Kato, a professor at the Hokkaido University Hospital, adding the kits would be vital in places such as Hokkaido, where medical resources are sparse.

The kit can be used to detect microRNA, a biomarker known for its link to early cancer biology, in a small amount of urine and help screen the risks of cancer in the lungs, colon and pancreas, among others.

Results of the survey using the test kits were announced at an annual meeting of the Japanese Association for Chest Surgery in May.

Among those aged 60 or older who had not taken a lung cancer test for five years or more, a tumor was detected in the lungs of a woman in her 60s that led to a detailed examination and successful surgery. The tumor was diagnosed as a "Stage 0" adenocarcinoma in situ.

Precancerous cells in the colon and pancreas were also detected among six people in the survey, according to the company.

In Japan, it is estimated that one in two people would develop cancer in their lifetime, while one in four men and one in six women will die from the disease, according to statistics of the National Cancer Center Japan.

© KYODO

©2025 GPlusMedia Inc.

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As with any new diagnostic test the devil is in the details. It is very important to see what is the sensitivity of the test, obviously it would not make sense to use it if half of the patients are not detected with a "false negative" result, but for tests that are planned to be used by a lot of people it is extremely necessary to know also the specificity. If 5 out of 100 patients get a positive result that is not real (a false positive) this would not seem to be as bad, but if 100,000 patients are screened that would mean 5,000 people would have the stress of being misdiagnosed with cancer and would likely have to be subjected to many other tests (that can come with their own risks) to eventually find out they have no cancer.

Hopefully this will be useful and precise, but no conclusion can be made based on the results of 100 tests, and the huge publicity efforts being done in the internet and media would seem unjustified and hasty.

1 ( +2 / -1 )

Wont do much because

1 it is very hard to convince doctors to do any cancer screening tests to confirm diagnosis required for treatment in Japan even when you offer to pay out of pocket. If this screening does not link directly to treatment it is not much value to the patients 2 even if early stage cancer is detected, the approach in Japan is often is just wait and observe until stage 3/4 where they finally agree to let you to receive treatment, and even then it can take months for them to move on anything. E.g if you have suspected stage 2 CRC, the doctors here will literally delay for 3-4 years until it is stage 4 and very painful before they are willing to proceed with any sort cancer treatment
0 ( +2 / -2 )

1 it is very hard to convince doctors to do any cancer screening tests to confirm diagnosis required for treatment in Japan even when you offer to pay out of pocket.

When it is a test with scientific support this is not the case, the opposite is much more frequent, with doctors prescribing tests and exams just to be safe even if the diagnosis is all but sure already.

2 even if early stage cancer is detected, the approach in Japan is often is just wait and observe until stage 3/4 where they finally agree to let you to receive treatment

That is definitely not the case, the different medical societies have guidelines that specifically describe what is the treatment the patient can expect for the different situations of their diseases.

E.g if you have suspected stage 2 CRC, the doctors here will literally delay for 3-4 years until it is stage 4 and very painful before they are willing to proceed with any sort cancer treatment

If a doctor does this he can easily be sued out of everything he owns and lose his license on top, the guidelines are extremely clear on this case and surgery is the treatment even for cTis without lymphatic node involvement. Waiting is not an option unless there is a specific reason why the patient can't be treated.

https://www.jsccr.jp/public/guideline20240130.pdf

(older version in English)

https://pubmed.ncbi.nlm.nih.gov/31203527/

The whole point of making the guidelines public is so the public can easily confirm what is supposed to be the treatment for their situation and make their treating physician responsible for any difference.

0 ( +1 / -1 )

The discussion about false positives sounds very important. Too many of those would be a burden on the medical establishment's resources, stressful for the patients, and expensive all the way around.

My doctor seems to put a lot of trust in blood tests for cancer screening. In my case, I am less worried about a false positive, which I have not had, than about a false negative.....if there is such a thing. I would hate to be walking around, feeling safe in the knowledge that I have no markers for cancer in my blood, and then told that I in fact do have cancer. Still, modern medicine sure has advanced a lot.

As for the test mentioned in this article, I hope it becomes another useful tool for medical professionals to use.

2 ( +2 / -0 )

The whole point of making the guidelines public is so the public can easily confirm what is supposed to be the treatment for their situation and make their treating physician responsible for any difference.

You can show the guidelines to the doctors and they won't budge. Very few doctors follow those guidelines. Most doctors are scared that if they provide a definitive cancer test and then not get reimbursed, this is particularly the case with younger patients.

My friend was literally stuck at no treatment for stage 2 CRC for close to 4 years until it spread to her liver and lungs when the doctors finally agreed to give her the definitive tests needed to proceed with treatment...

0 ( +1 / -1 )

You can show the guidelines to the doctors and they won't budge

Yes they will, because if not that is reason enough to be declared incompetent and the patient can get everything on a lawsuit, the medical professional colleges and associations are not on the side of a doctor that chooses to ignore the guidelines, that is their whole purpose.

Very few doctors follow those guidelines. 

On the contrary, every doctor that wants to be accredited have to demonstrate to follow them, and without a valid reason deviating from those is reason enough to lose those accreditations, in Japan the medical community is a vertical society and disobeying the specialty colleges is seen extremely negatively.

My friend was literally stuck at no treatment for stage 2 CRC for close to 4 years until it spread to her liver and lungs when the doctors finally agreed to give her the definitive tests needed to proceed with treatment

Even if that is true (and for hearsay by definition this is not something that can be corroborated) in no way it would prove this is normal, or even remotely common. If someone came and say that a doctor did the full treatment for their cancer completely free just because of niceness it would hold the same value as an argument to prove doctors give away treatments for free all the time, zero.

-1 ( +0 / -1 )

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