The Fermiscan Test is not yet available commercially. Fermiscan completed a validation trial in 2008 and is now in the implementation phase of bringing the test to market. The steps will involve focusing on further development of the Fermiscan Test and building a knowledge base by conducting on-going clinical studies. It is important that all women continue with their regime of regular screening options as early detection is the overall objective.

	Fermiscan Test benefits
	Fermiscan Test requirements

Fermiscan Test Benefits

The Fermiscan Test is innovative, non-invasive, painless and is suitable for women of any age or breast composition. The Fermiscan Test relies on testing samples of the patient's hair, rather than direct imaging of the breast therefore issues of concern regarding other radiology technologies such as long term safety and breast tissue density do not apply.

The Fermiscan Test could initially be used as an adjunct with routine screening options as early detection is the overall objective. The earlier breast cancer is detected the greater the benefits such as increased survival, increased treatment options and improved quality of life. In younger women where there is no standard screening test, the Fermiscan Test may provide a reliable screening option.

Preliminary work indicates that the technology has the potential to monitor the recurrence of breast cancer following treatment and may assist in improving the accuracy of mammography when used in conjunction with the Fermiscan Test.

The validation trial results (2008) demonstrated a high level of overall accuracy[1]. In general the trial showed that the test performed better in younger women.. When coupled with safety and convenience factors the Fermsican Test compares favourably to existing screening methods [2, 3].

The results from the validation trial showed that if a patient has a negative Fermiscan Test result then there is a 99% chance they do not have breast cancer (negative predictive value). If the patient's hair X-ray diffraction pattern was abnormal (shows a ring) then there is a 5% chance that they are positive for breast cancer (positive predictive value).The validation trial also confirmed that the Fermiscan Test offers possible reduction in invasive procedures such as Fine Needle Aspiration (FNA) or Core biopsies. 85% of women cleared of having breast cancer following biopsy were correctly identified as negative for breast cancer by the Fermiscan Test.

Fermiscan Test Requirements

The Fermiscan Test requires a sample of twenty (20) strands of scalp hair and these must have four (4) weeks of new growth of hair (10.5mm). It is critical for the reliability of the test that these hairs are free of treatments such as dyes, perms, or heat/chemical straightening.

The hairs will be sent to Fermiscan for mounting onto a specially designed loading device, checked for the presence of dyes then transported to a synchrotron for X-ray diffraction. The diffracted X-ray patterns are analysed to determine if subtle changes are present in the pattern that are indicative of the presence of breast cancer. The results will be checked and sent to the patient's medical practitioner with advice as to what the results may mean and suggestions for further action if required.

References (Refer to the accuracy section for the chart and tables)