my insights, page-8

Taxi_service - I hope these comments satisfy your request for a response.

First - some background. My reading of the statistics shows that 1 in 8 women in Australia will develop breast cancer in their lifetime - but less than 1% of women in any one year will develop breast cancer. Currently around 800,000 mammograms are performed in Australia per annum. They are overwhelmingly done on women between 50 and 69, for two reasons - younger women have denser breasts and therefore mammography doesn't work so well; and secondly mammography exposes women to significant levels of x-rays which over time could induce breast cancers. (It's interesting to note that a recent paper demonstrates that breast density is a risk factor for breast cancer - ironically mammography works less well on dense breasts, yet women with dense breasts are more likely to get breast cancer. Therefore there is a need for a better/different testing method). Whilst most mammograms are negative, mammograms find a lot of lumps, around 80% of which are not cancerous, which is discovered after biopsy followed by pathology - a quite expensive procedure. Often the biopsy misses the lump, so it must be performed again.
So women younger than 50 need to rely on breast self-examination to find lumps - a technique which is highly unreliable. Clinical breast examination is more reliable. Once a lump is felt, it must be imaged and/or biopsied, and most of the time it is not cancer. But to find thi s out, an invasive procedure must be performed.

Now to Fermiscan's technology.
The Fermiscan test (and other "biomarker" tests for that matter), if as sensitive as the data to date suggest, primarily can rule out the presence of breast cancer, as the overwhelming majority of the population (99%) will be negative. Remember that a positive mammogram does not mean a breast cancer - it means that there is a lump that needs further work. Most of these lumps are not cancers.
So the Fermiscan test may save the government a lot of money by significantly reducing the numbers of screening mammograms (and follow-up biopsy and pathology) performed.

Contrary to your assertion, it is possible that the test could in fact save the government money.

Now addressing the issue of false positives in the Fermiscan test. The International Journal of Cancer paper, which reported the results of tests of 503 samples from women with "known" breast cancer status (i.e. in comparison to mammography), showed a false positive rate on samples gathered from breast clinics of 15%. This was in comparison to a negative mammogram. Mammograms miss between 10% and 50% of tumours (figures vary widely between practices and countries, but the recent DMIST study in the US which compared digital with film mammography is a screening setting showed a 41% sensitivity (i.e. 59% of cancers were missed) [New England J Med 353:1773-83) so it is possible that many of those false positives were in fact true positives missed by the mammogram for various reasons. In fact the note at the bottom of the Table in the International J Cancer paper says that in some cases those false positive women went on to develop breast cancer, implying that the tumour was present, but missed by mammography.

In the case where there is a positive result, the first thing to do would probably be a clinical breast examination, followed by an ultrasound and/or a diagnostic mammogram. I imagine that this would be a similar procedure if a woman presents with a breast symptom - such as a discharge from the nipple. If there was no evidence of a lump, then a regular monitoring program could be set up in consultation with a woman's doctor, just as they would do if there was a nipple discharge with no lump found. There are precedents for this in medicine - Pap smears that find evidence of HPV 16/18 and colonoscopy that finds benign polyps for example.

Contrary to your assertion, a positive Fermiscan test would only result in surgery if a lump was found!

Another interesting potential for this test is as a monitoring of recurrence of disease post-surgery. If it can detect early reappearance of cancer then it could be used as a regular monitoring for treatment options in breast cancer patients.

This potential is shown in the International Journal of Cancer paper, which in addition to the 503 human hair samples, also showed that if mice are given breast cancer by implantation of human breast cancer cells, the whisker showed the ring after about 2 weeks. This means that the appearance of a cancer can show up quite early after it occurs.

A test that can potentially rule out the presence of breast cancer for women of any age to a high degree of accuracy is an exciting prospect. Early detection can save lives.