Polartechnics ramps up for Italian job

Device maker Polartechnics is to focus on the Italian market for the introduction of its TruScreen cervical cancer diagnostic device, as a precursor to a major push into the European screening arena.

"We are starting to move towards commercial activity now we have finished the clinical trial segment of our development. We have gained CE approval as a diagnostic assistant device we think Italy offers the best opportunity for establishing a commercial market," said marketing manager Colin Stahel.

Stahel said the advantages of the TruScreen over other alternatives were its very high recognition capability, based on opto-electronic measurements of human tissue, interpreted through specially designed algorithms. The system, designed in collaboration with CSIRO Image Analysis group, uses a special probe and a three-chip recognition system to analyse the tissue type in real time.

"Our system gives very high recognition, it sees disease that a conventional PAP Smear test doesn't. We look for tissue characteristics that the Pap test can't identify," said Stahel. The many different tissue types of the cervix, both normal and diseased, are identified and classified according to a defined histologic or colposcopic gold standard, and compared to normal readings.

The other advantage offered by the system is the inclusion of calibrated scanning into the memory of the unit. Stahel noted that this enables changes to each individual area of tissue or growth to be checked and compared on subsequent occasions.

"The inclusion of calibrated scanning means that doctors can compare apples with apples, and see if there has been a change," he said. "It allows the doctor not just to see if there is any sign of irregularity in the tissue, but if it has altered -- if it is in need of excision or not," he added.

The system correlates data from the colour, shape and texture of the sample inspection site, and uses a custom algorithm to identify the likelihood of the need for further tests.

"We have achieved a nexus between scientists, clinicians and development groups to get a clinically significant information result. It is not overly complex, but it is very accurate, and used in conjunction with a Pap smear it can give considerable peace of mind to patients," asserted Stahel.

The company has targeted the Italian market for several reasons, said Stahel. "Italy has the largest private gynaecological market in Europe, with over 7000 private practices; it has a well established health system, and it offers an excellent way to introduce the product into the European market," he said.

Polartechnics anticipates submitting TruScreen for FDA approval in the near future, but in the immediate future will concentrate on marketing TruScreen's sister device, Solarscan, into the North American market.

SolarScan is a melanoma diagnostic which uses similar image recognition technology to detect early-stage skin cancers.