Fermiscan Test
In 1999, Australian physicist Prof. Veronica James and her colleagues, Dr John Kearsley, Dr Tom Irving, Prof. Yoshiyuki Amemiya and Dr David Cookson, published a paper in Nature in which they reported that by using X-rays generated by a synchrotron, they observed a correlation between the incidence of breast cancer and an observed change in the X-ray diffraction pattern of hair from afflicted individuals [1]. The diffraction patterns of all hair samples (23 out of 23) collected from women diagnosed with breast cancer exhibited the change. Of the samples taken from patients not suspected of having breast cancer, 86% (24 out of 28) of the diffraction patterns were normal.
A study published in the International Journal of Cancer in 2005 [2], presented data that extended these numbers to 503 human samples with similar levels of sensitivity and specificity and also provided evidence that the diffraction change specific to breast cancer can be observed in an animal model of breast cancer.
In January 2008, in the International Journal of Cancer 2008 [3], the results of studies performed by Fermiscan scientists, independently of the original inventor, were presented.
The data broadly confirmed the original inventor’s findings (that breast cancer can be detected by synchrotron X-ray diffraction of hair). The accuracy of diagnosis was 89%, which compares favourably with current breast cancer screening methods [4]. Sensitivity – the ability to detect breast cancer – was 90%, and specificity – the ability to detect the absence of cancer was 87%, confirming the technology’s high accuracy.The scientists concluded that the data showed that “there is a correlation between an altered X-ray diffraction pattern of hair and the presence of breast cancer, (and therefore the technique) has the potential to provide a non-invasive test for the presence of breast cancer”.
In a further significant development, this study showed evidence that the technology could be used to monitor the success of cancer treatment, which would significantly expand the clinical value of the test should the finding be confirmed in larger studies
Fermiscan has completed a 2,000 patient validation trial of this technology. The trial results have broadly confirmed the early findings.
The Fermiscan Test requires a sample of twenty (20) strands of scalp hair and these must have at least four (4) weeks of new growth of hair (10.5 mm in length). It is critical for the reliability of the test that these hairs are free of treatments such as dyes, perms, or heat/chemical straightening. The hair is cut from the scalp behind the middle of the ear.
The hairs are sent for testing and analysis at a synchrotron facility in the US. They are exposed to a finely focused X-ray beam for up to thirty (30) seconds. The diffracted X-ray are collected as an image which is then analysed to determine if subtle changes are present in the image that are indicative of the presence of breast cancer.
It is essential that women continue their regime of routine (self and clinical) examinations and mammograms, ultrasounds and MRI as early detection is the overall objective. The earlier breast cancer is detected the greater benefits as increased survival, increased treatment options and improved quality of life. It is expected that the Fermiscan Test could initially be used as an adjunct to routine screening options.
Fermiscan plans to develop the hair test by establishing links with key medical specialists and cancer centres within Australia and internationally, (Singapore, Italy and Japan). Through these links, Fermiscan will continue to conduct clinical studies focused on improving the accuracy of the test in conjunction with current screening technologies. This strategy will enable Fermiscan to understand the expectations of local clinicians, patients and regulatory bodies, as well as developing relationships with local clinics for distribution of the Test when appropriate.
References
[1] James V, Kearsley J, Irving T, Amemiya Y, Cookson D. Using hair to screen for breast cancer. Nature vol. 398: 33-4, 1999.
[2] James V, Corino G, Robertson T, et al. Early diagnosis of breast cancer by hair diffraction. Int. J Cancer ; vol. 114: 969-72, 2005.
[3] Corino G, French P. Diagnosis of breast cancer by X-ray diffraction of hair.
Int. J Cancer ; vol. 122: 847-856, 2008.
[4] Studies conducted in UK, Singapore, Australia and USA. Click here for details