Australian company Fermiscan has demonstrated that its new breast cancer screening test, which analyses an individual's hair, has an accuracy rate of 69 per cent.

The Australian company Fermiscan, who is using a US synchrotron in the development of a new breast cancer screening test through the analysis of an individual's hair, has demonstrated an accuracy rate of 69 per cent in detecting breast cancer.

A recent study published in the Journal of the American Medical Association[1] showed that breast screening using either mammography or ultrasound achieved no greater than a 50 per cent sensitivity at detecting breast cancer. A sensitivity of 78 per cent was achieved when techniques were combined. Fermiscan recently completed a similarly sized clinical trial[2] designed to compare results from current screening methods of mammography, ultrasound (and any subsequent biopsy and pathology results) with the Fermiscan Test. Fermiscan's study demonstrated a sensitivity rate of 61 per cent and an accuracy rate of 69 per cent in detecting breast cancer. If defective hairs were removed from the study (hairs treated with dyes or other chemicals) the accuracy rate of the test increased to 75 per cent.

The result of Fermiscan's trial also showed that 80 per cent of the patients referred for a biopsy as a result of imaging were correctly identified as negative by the Fermiscan Test. This highlights the test's potential value through the prospective reduction in unnecessary invasive procedures such as biopsies.

The NSW Minister for Science and Medical Research, the Hon. Verity Firth highlighted the comparison at BIO 2008, the world's largest biotech convention held in San Diego (June 17-20) this week.

The Minister noted that the Sydney company, recently named the Austrade 'Innovator of the Year' was still in the development stage with the technology and that women should continue to use all current diagnostic tests. The minister stressed that early detection is the primary objective and that women could include the Fermiscan Test as part of their routine screening options when it is available.

Minister Firth said women would find the potential accuracy rate of 75 per cent for the Fermiscan Test very encouraging. The Fermiscan Test, included as part of routine screening, promises to be a powerful new tool in the fight against breast cancer which globally claims 500,000 lives a year[3].

One in eight women in Australia and the USA will develop breast cancer in their lifetime[4] and the global incidence of the disease is one million annually[3]. Currently the 'gold standard' for detecting the disease is mammography.

According to Fermiscan's CEO, David Young, "The Fermiscan Test has the potential to provide a non invasive, fast and accurate addition to existing technologies for the detection of breast cancer in women of all ages. This test is not aimed at replacing mammograms, ultrasound or other diagnostic technologies, but we hope it can be a test that eventually will become part of the arsenal of early detection techniques for the disease," he said.

The Fermiscan Test is based on the discovery that women with breast cancer have a change in the structure of their hair which is detected using a technique called X-ray diffraction. This change is seen as a ring superimposed on the normal X-ray diffraction pattern of hair. [See images on http://www.australiabio2008.com/FermiscanNMR.php]. The research has been published in the prestigious scientific journals as Nature (1999)[5], the Journal of the National Cancer Institute (2001)[6] and the International Journal of Cancer (2005 and 2008) [7, 8].

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 focussed 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.

The recently announced acquisition of Sydney Breast Clinic, one of Australia's leading providers of diagnostic services for breast cancer, has a strategic fit that aligns the objectives of both groups to improve health outcomes for women. Sydney Breast Clinic was a major participant in Fermiscan's successful 2,000 patient trial. The continued collaboration with the Sydney Breast Clinic will significantly help the development and future commercialisation of the Fermiscan Test.

[1] Berg W, et al. Combining screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA 2008; 299(18):2151-63.

[2] Fermiscan validation trial (2,000 patients) May 2008

[3] American Cancer Society 2007 (Cancer Facts and Figures 2007) and http://www.nbcc.org.au/

[4] Time The Changing Face of Breast Cancer 15 October 2007

[5] James V, Kearsley J, Irving T, Amemiya Y, Cookson D. Using hair to screen for breast cancer. Nature 1999;398:33-34.

[6] Meyer P, James VJ. Experimental confirmation of a distinctive diffraction pattern in the hair from women with breast cancer. J Natl Cancer Inst 2001;93(11):873-875.

[7] James V, Corino G, Robertson T, Dutton N, Halas D, Boyd A, Bentel J, Papadimitriou J. Early diagnosis of breast cancer by hair diffraction. Int J Cancer 2005;114:969-972.

[8] Corino G, French P. Diagnosis of breast cancer by X-ray diffraction of hair. Int J Cancer 2008; 122:847-856.

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