A screening device for cervical cancer and pre-cancer, developed by Australian company Polartechnics in collaboration with CSIRO, has entered final clinical trials for regulatory approval for use in Europe.

Over half a million women worldwide are affected by cervical cancer every year and the TruScan® system has the potential of reducing mortality rates through higher accuracy and instant diagnosis.

Trials conducted last year demonstrated that TruScan® is significantly more accurate than the Pap smear. These tests were done using an interim product and a subset of the female population – those who had already returned a positive Pap smear.

The present trials are being done on the commercial product and are designed to be representative of the entire female population at risk of cervical cancer.

Mr Victor Skladnev, Managing Director of Polartechnics, says that the trials will be done under the direction of leading gynaecologists and will directly compare the performance of TruScan® and Pap smears.

"Patients will receive both a Pap smear and a TruScan® procedure and the two procedures will be assessed against the gold standard of a histological examination (microscopic examination of cells)," says Mr Skladnev.

The trials will be carried out firstly in London and Sydney and then in Milan, Barcelona and Paris, with a city in Germany to be selected in due course.

TruScan® uses a pen-like probe to collect information directly from the cervix about the colour and electrical properties of cervical tissue. A single-use sensor, which is a plastic sheath that fits over the probe and is used only once, ensures that the process is safe and hygienic.

A computer attached to the probe analyses the data and classifies the tissue as healthy, pre-cancerous or cancerous.

"TruScan® delivers a less invasive test and a quicker result," says Mr Skladnev

CSIRO made a major contribution to the system by developing advanced mathematical algorithms to do the analysis of the spectral and electrical data.

Professor Daniel McMichael of CSIRO says that the collaboration was a good example of how mathematical skills closely integrated with a company's development process can be a key generator of success in high technology projects.

"Polartechnics needed TruScan® to be significantly better than its competition. We showed how to optimise its performance relative to Pap, and provided the mathematics and programs for doing it."

The initial purpose of the trials is to support an application to the European medical device authorities for a CE Mark. This will permit the marketing of TruScan® throughout the European Union, and certain other countries which accept a CE Mark as the basis for granting their own approval. Polartechnics already has authorisation for TruScan® from the Australian Therapeutic Goods Administration.

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More information:

Prof Daniel McMichael, CSIRO, (08) 8303 8773, mob 0407 086 673, daniel.mcmichael@csiro.au