This is great news. Now onto commercialisation and the reward for all of us who have held.
Fermiscan successfully completes validation trial
Fermiscan Holdings (ASX: FER), which is commercialising a non-invasive test for breast cancer, today announced the successful completion of its 2,000 patient trial, which commenced in 2007.
This large scale trial was designed to compare results from the current breast cancer screening methods of mammography and ultrasound (and any subsequent biopsy and pathology results) with the Fermiscan test. The trial confirmed the ability of the Fermiscan test to detect the presence of breast cancer, using x-ray diffraction of hair.
Accuracy of 69% was achieved, and by exclusion of patients whose hair was subsequently analysed and independently confirmed as having been treated and damaged, the accuracy is 75%. The company’s validation phase is now complete.
In light of the positive results from the trial and continuous progressive improvement to operations, Fermiscan plans to progress to commercialisation of the test in Australia in 2008.
Validation phase and trial outcomes include:
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Overall accuracy level of the Fermiscan test in the 2,000 patient trial was 69% (75% after exclusion of damaged hair) - see attached summary tables
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Correct diagnosis of almost 1500 women as negative for breast cancer and 20 patients correctly as positive for breast cancer
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Correctly identified as negative for breast cancer 80 per cent of patients referred for a biopsy as a result of mammography. This highlights the potential value of the test in conjunction with current screening methods
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13 patients found to be positive for breast cancer by a mammogram and biopsy were missed by the Fermiscan test. This is believed to be due to damage to hair from treatments not identified by fluorescence screening and/or biological variation. The accuracy of the test can be affected by hair treatments such as perming, dyeing and straightening, which can be overcome in most cases by using new growth of the hair (approximately 4 weeks required)
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The accuracy of the test in a commercial use is expected to significantly improve as women will prepare for the test by ensuring they have undamaged new growth of hair for testing. During the trial this could not take place as patients had no advance notice of the test and the requirements
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The value of the test for women of all ages was confirmed with patients covering a wider age group than current screening recommendations
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Optimisation of synchrotron beam-lines to significantly improve high resolution images
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Automation improvements to extend commercial capacity
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Significant progress made towards securing access to synchrotron beam lines in key countries
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Secured the support of key medical and patient advocate groups
Fermiscan Managing Director Mr David Young said, “We are extremely pleased to have validated the commercial potential of the Fermiscan test. Given its non-invasive nature, suitability for women off all ages and comparative accuracy relative to other screening methods currently available, the commercial potential is significant.”
Fermiscan will now commence commercial development in Australia and overseas. This development path includes:
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Further analysis of the data from the 2,000 patient trial to refine the analysis methodology and criteria to further improve the accuracy of the test
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Commencement in the next few months of approved clinical research with leading hospitals in Italy and Japan as well as the Ashford Cancer Centre, a leading Cancer Clinic in Adelaide. Fermiscan plans to gather data from patients with a range of breast cancers (and other cancer patients) to allow further refinement and improvement of the test
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Securing time on third generation synchrotron beam lines in key countries
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Developing key statistical findings and communication messages
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Implementing a detailed Research & Development plan to allow further development of Fermiscan’s technology
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Plans to progress to commercialisation of the test in Australia in 2008
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Commencing regulatory approval processes internationally
Sue Murray, the CEO of the National Breast Cancer Foundation, said, “Research underpins all the advances in breast cancer diagnosis, treatment and on-going care. Breast cancer is most effectively treated when detected early and this new technology from Fermiscan is showing very strong results.
Further testing will confirm the benefits and potentially offer improved survival for women of all ages. We look forward to the results from the clinical research to be undertaken both overseas and in Adelaide.”
Fermiscan Managing Director Mr David Young said “We are pleased to be moving into this exciting phase of development. The support we have had from the hospitals and clinics involved in the trial has been very encouraging and I would also like to thank all the patients who have participated in the trial. We look forward to this continuining support to improve the health outcomes of women worldwide as we develop our scientific, medical and commercial capability”.