Fermiscan hair x-ray showing ring present in fibre diffraction pattern. (PRNewsFoto/Fermiscan) SAN DIEGO, CA UNITED STATES

    SAN DIEGO, June 19 /PRNewswire/ -- 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% in detecting breast cancer.

    (Photo: http://www.newscom.com/cgi-bin/prnh/20080619/AQTH082)

    A recent study published in the Journal of the American Medical
Association(1) (US study), showed that breast screening using either
mammography or ultrasound achieved no greater than a 50% sensitivity at
detecting breast cancer. A sensitivity of 78% 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% and an accuracy rate of 69% 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%.

    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%
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.

    References

    (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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     Susan Fitzpatrick
     susan@datelinemedia.com
     In San Diego Cell: 650 279 7771

     Tania Ewing
     In Australia Cell: 0408378422
     taniaewing@healthinbox.com

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     US office:650 798 5238

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