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What are the requirements for the test?
The Fermiscan Test requires a sample of twenty (20) strands of hair, cut from the scalp in the area behind the middle of the ear. It is critical for the reliability of the test that hair shold not be treated (such as dyed, permed, or heat/chemical straightened) for at least four (4) weeks prior to collection. If the hair was treated more than four (4) weeks ago the test results can be clearly determined
Fermiscan has found when conducting clinical trials that the requirement of four weeks of new growth fits in with women's lifestyle patterns, for colouring etc, of their hair. This will require a woman to plan in advance to have a Fermiscan Test, as hair that has been damaged by these treatments will not be able to be analysed by Fermiscan. Fermiscan will communicate these details as part of the education process to women and to medical professionals.
Who can have the test?
The Fermiscan Test is not yet commercially available. When it is available it will be suitable for women of all ages and types of breast composition. As the Fermiscan Test relies on testing samples of scalp hair, rather than direct imaging of the breast, thus issues of concern for mammography such as long term safety and breast tissue density do not apply.
When will the test be available and should I wait for the Fermiscan Test?
No, it is essential that women continue their regime of routine (self and clinical) examinations of mammograms, ultrasounds and MRI, as early detection is the overall objective. The earlier breast cancer is detected the greater the benefits such as increased survival, more 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.
Following completion of the clinical trial, the company has entered the research and development phase of the test. There are a number of steps involved in this process and Fermiscan is looking to ensure they are undertaken as quickly as possible in order to bring the test to the market. These will include further analysis of clinical trial data to refine the analysis methodology and criteria to improve the accuracy of the test. Registering for the email alerts is the best way to keep informed of the availability of the Fermiscan Test
Where can I have the Fermiscan Test?
The distribution of the Fermiscan Test will be determined following the completion of the development process however it is most likely to be in association with medical practitioners.
How long does the test take and are samples analysed in Australia?
Currently, hair samples collected under clinical trial protocols are sent for testing and analysis at a synchrotron. In a commercial setting, it is planned that the results will be provided back to the patient's medical practitioner. It is anticipated that the waiting period for the results will be around two weeks. The time is expected to be reduced once the process is fully operational. Fermiscan is currently in early discussions with the Australian synchrotron management and is looking at the possibility of designing and developing a commercial beamline for breast cancer testing and other associated commercial considerations.
Can you use samples from other parts of the body?
Fermiscan has found that scalp hair is the easiest to collect and the most reliable (provided there is sufficient new growth of untreated hair). Pubic hair has been tested as part of our sample collection in the recent validation trial but it was found that pubic hair does not provide consistent results.
Where can I find out more information on breast cancer?
Fermiscan recommends contacting organisations as those listed below:
The Sydney Breast Clinic - www.sydneybreastclinic.com.au
The National Breast Cancer and Ovarian Cancer Centre - www.nbcc.org.au
The National Breast Cancer Foundation - www.nbcf.org.au
The Breast Cancer Network Australia - www.bcna.org.au
The Cancer Council - www.cancer.org.au
Click here for additional Frequently Asked Questions on the research and development of the Fermiscan Test
The Validation Trial
What were the outcomes of the trial?
The recently completed clinical trial (2,009 patients) demonstrated an overall level of accuracy of 77%. In general the trial showed that the test performed better in younger women. To view the validation trial results click here. When commercially available the accuracy is expected to 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
Fermiscan plans to develop the test by establishing links with key medical specialists and cancer centres both in Australia and internationally. Through these links, Fermiscan will continue to conduct clinical studies focused on improving the accuracy of the test in conjunction with current screening technologies.
How does the level of accuracy compare to other methods?
The overall accuracy level of the Fermiscan Test compares favourably relative to other screening methods currently available. International studies of mammography and other screening methods have shown there is a range of accuracy levels. (See the tables 2 and 3 below for comparative results to current screening methods and against international studies).
Table 1 Comparison of Fermiscan Test to current screening methods
Table 3 International studies on mammography and other imaging methodologies
What is significant about this trial?
This was the first trial of the technology in the 'real world' setting of patient clinics, under Good Clinical Practice (GCP) conditions. Samples were blinded, and results were independently audited by PricewaterhouseCoopers. The results from this trial and subsequent studies will assist medical practitioners and the general public to assess the reliability of this innovative technology.
Click here for additional Frequently Asked Questions on the research and development of the Fermiscan Test
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