Trial results

Fermiscan released early results from its Australian trial in December 2007, which was designed with the assistance of a biostatistician to ensure a statistically significant result. From those 800 women tested, the company ended up with a sensitivity and specificity of around 80 per cent.

Young says that is comparable with other diagnostic tests such as mammography and is probably an advance on most countries' mammography standard.

In May, the validation trial was completed with an accuracy of 69 per cent, which grew to 75 per cent once samples from patients who had chemically treated their hair were excluded.

The company is also conducting a trial in Singapore as a way into the vast Asian market. The Singapore trial, at the KK Women's and Children's Hospital, is a 200-patient, controlled clinical trial designed to compare results of the Fermiscan test with the current gold standard breast screening methods of mammography and ultrasound, with follow-up biopsy and pathology.

Fermiscan licensed six countries in south-east Asia early in its development process, Young says. He has more than a decade of experience working in Taiwan, Hong Kong and Singapore and felt that a licensing model was the best entry platform to the market.

"The trial in Singapore is a population specific trial to get the engagement of the medical community and clinical acceptance in Singapore and therefore by default it flows to most other parts of south Asia," he says.

All trials will follow the processes developed in Australia. The samples are collected and sent to Fermiscan, who arranges for them to be tested at the synchrotron beamline in Chicago, which is managed by US chief scientist Gary Corino.

"At the moment we are using the synchrotron in Chicago for the trial but we have agreements in place with the Australian Synchrotron, which would be the logical place for Australia, but their development timelines are still a little further away," Young says.

"In its implementation phase as a diagnostic test, the hairs would be collected and sent to us, we would load them and run them through our diagnostic process on a synchrotron beamline, and electronically communicate the records back. Our estimate is that that would take somewhere between a week and 10 days in the initial stages."