If the test is used as a SCREENING tool for women under 40 (who do not undergo screening mammography due to high radiation dose), then surely 1 million per year in Oz would be easily surpassed
. The question is, how long will it take to get to 1 million tests?
If the test is used as a SCREENING tool for women under 40 (who do not undergo screening mammography due to high radiation dose), then surely 1 million per year in Oz would be easily surpassed.
I thought it was not used on women under 40 due to the fact that it is inaccurate because women under 40 have dense breast tissue (even though the radiation is an issue for all women having mammograms!).
QUOTE]
That is also true, but the sensitivity of various organs (eg breasts, ovaries, thyroid) to radiation decreases with age, and so any screening tool which is non-invasive and does not involve ionising radiation bound to be a winner.
I thought it was not used on women under 40 due to the fact that it is inaccurate because women under 40 have dense breast tissue (even though the radiation is an issue for all women having mammograms!).
QUOTE]
That is also true, but the sensitivity of various organs (eg breasts, ovaries, thyroid) to radiation decreases with age, and so any screening tool which is non-invasive and does not involve ionising radiation bound to be a winner.
That is a good bit of information. From a female perspective, if one has a choice, the no radiation option would be my first point of call (perhaps I'm a little biased though!).
drasicjazz
Does anyone know the cost of a mammogram to government? Fermiscan looking at $200/test from links by drasic ($100 of that is profit).
MRI -
* Costy $400-$600
http://www.theage.com.au/news/natio...-risk-of-cancer/2007/10/21/1192940905887.html
MRI +
* much better visual picture
cheers
This analysis showed that earnings before interest, tax, depreciation and amortisation (EBIT) for a volume of one million tests in a full operational year, including 500,000 tests sold by licensees, would be approximately $103 million.
For 500,000 Fermiscan tests, the analysis showed EBIT of $61 million and break-even was achieved at 80,000 tests annually.
International development
We have continued to further our commercial development strategy in
Australia and internationally. Fermiscan owns the technology on which the
Fermiscan test is based, and a family of international patents protects the
company’s intellectual property.
South East Asia
A clinical trial of the Fermiscan test commenced in January 2008 with the
support of KK Breast Centre of the KK Women’s and Children’s Hospital,
Singapore’s largest medical facility providing specialist care for women
and children. The potential market for the test in Singapore is estimated to
exceed 1.7 million people.
Licences to market the Fermiscan test have been granted in six Asian
countries, including Hong Kong, Singapore, Malaysia, Indonesia, Thailand
and Vietnam. The combined potential market in these countries is an
estimated 11.5 million people.
Japan
In Japan, we plan a limited clinical trial, following completion of an independent feasibility study which concluded the Fermiscan test would be a strong complement to existing screening methods for breast cancer.
Japan is a significant market, with 37 million women aged over 40 years.
Use of mammography is expected to increase as Japanese health
authorities increase promotion of breast cancer awareness. Currently
14 million mammograms are performed each year, which is a low
proportion of the eligible population compared to Western countries.
We are preparing a detailed path of regulatory approval and trials to enter
this market which is expected to take two years.
The Japanese study estimated a conservative market potential of the
Fermiscan Test at an initial 541,000 tests in 2010, growing to 2.9 million
tests in 2015. The potential financial benefit to Fermiscan from the
Japanese market alone is substantial.
USA
In the USA, we are evaluating our ability to seek FDA fast track status to accelerate regulatory approval. This may be granted where the FDA believes there is an unmet medical need or low risk to patients.
Europe
Recently, the company was granted a new patent in Europe, which includes
breast cancer, prostate cancer and Alzheimer’s disease. This patent
extends Fermiscan’s patent protection into 19 countries in Europe.
Extending application of Fermiscan’s technology
There is significant potential to adapt this non-invasive test for other
diseases, and we continue to explore these opportunities. Currently, the
company is preparing a trial designed to validate if the presence of prostate
cancer can be detected through x-ray diffraction of hair.
Clinical trials
The company began an Australian 2000-patient trial to validate its test in
2007 with the support of major Australian radiology and diagnostic groups.
Results from the trial compare the effectiveness of the Fermiscan test with
screening results from mammogram and ultrasound, and any subsequent
biopsy and pathology results.
We are pleased that results so far have confirmed a high degree of accuracy
for the Fermiscan test (80%) which compares favourably with published
studies for the accuracy of mammography.
To date, analysis of 808 patients has shown accuracy of the Fermiscan
test to be approximately 80 per cent. The test correctly identified 77 per
cent of women confirmed to be breast cancer negative by mammography
and ultrasound, and 82.3 per cent of women diagnosed as breast cancer
positive by mammography and biopsy were identified by the Fermiscan test.
In 91 per cent of cases where women with unclear mammography results
had been given a biopsy, the Fermiscan test correctly identified that they did
not have breast cancer. This initial result suggests that the potential for the
use of the Fermiscan test, together with mammography, could reduce the
need for some unnecessary biopsies.
Completion of the trial was delayed as, despite strict procedures for hair collection, many samples were damaged by treatments such as dyes, perms and chemical straightening; or lacked the required minimum of four weeks of untreated new hair growth.
We have improved systems and processes for hair collection, screening for treatments, loading and analysis systems at the synchrotron and enhanced numerous other aspects of our operations. More than 1500 samples of women’s hair have been collected from participants in the trial, and completion is expected in the first half of 2008.
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