Sydney, Australia - Polartechnics Limited announced it had reached a strategic agreement with its preferred business partners, Genera Biosystems and Healthscope, for the commercialisation of CerviScreen, which is a new device to identify sexually transmitted Human Papillomavirus (HPV) using self-sampled specimens. HPV is the virus known to cause cervical cancer. CerviScreen, which is to be launched initially in Australia, South East Asia and Europe, could dramatically improve the detection rates of women at risk of developing cervical cancer.
For the initial Australian launch it is envisaged that women will be recommended for the CerviScreen test by their doctors. Women will perform their own vaginal swab using Polartechnics' specifically designed Genswab collection device, provided in the CerviScreen kit. The swab will be sent to Gribbles Pathology, where it will be tested for the presence of highrisk HPV using Genera Biosystems proprietary PapType HPV detection and genotyping test. Test results will be reported back to the woman's nominated doctor, who may recommend further tests, including a conventional Pap smear.
Professor Neville Hacker, Director of the Gynaecology Cancer Centre at the Royal Hospital for Women, Sydney and Chairman of the Medical Advisory Committee and Director of Polartechnics said, "Early feedback from doctors indicated their support for a non-invasive selfsampling device that would supplement their efforts in maintaining and increasing participation in cervical cancer screening".
HPV is one of the most common sexually transmitted pathogens. Of the 14 "high-risk" HPV types known to cause cervical cancer, two types, 16 and 18, are the most prevalent in western countries. Polartechnics has elected to use the superior Genera Biosystems PapType test, as it can not only detect all high-risk HPV types, it can also determine which particular HPV type is present.
Recently, vaccines have been launched against HPV types 16 and 18 and are directed through Government supported national programs to mostly early teenage schoolgirls. This is raising the community's awareness of the link between HPV and cervical cancer and of the need for all women to maintain regular screening even after vaccination. Ongoing screening remains important as HPV types 16 and 18 account for only 70% of cases of cervical cancer.
CerviScreen will fulfil the ongoing need for community screening by drawing unscreened women to the medical profession whereby they will be more likely to avail themselves of cervical cancer screening services.
In Australia, the recommended Pap screening interval for women is every two years. A recent report noted that approximately 40% of women had not undertaken a Pap smear within the previous two years. The existence of a persistent level o f non-participation in Pap screening is common to all markets.
Recent studies have reported that of the women that would not present for Pap smears, approximately 90% would be prepared to self-sample for a HPV DNA screen if the opportunity were available.
Professor Hacker said, "CerviScreen is potentially an important advance in decreasing the mortality from cervical cancer. Although Pap smears have significantly reduced the burden of this disease in the Western world, many women choose not to have Pap smears for a variety of reasons. In the Western world, most cervical cancers occur in women who have been noncompliant with the screening program. The simple self-sampling process of CerviScreen should provide a convenient alternative for these women. A positive result would be the catalyst for them to seek further medical assessment, and should result in the early detection of cervical cancer or pre-cancer".
In assessing the commercial p o tential for CerviScreen as an HPV test initially targeting those women who do not regularly participate in Pap smears, the target markets of Australia and New Zealand, South East Asia and Europe comprise at least an estimated 70 million non-screening women. Assuming these women adopted CerviScreen and tested once every five years, as is currently being recommended for HPV screening by the medical profession, the potential revenue from the market is in excess of A$3.5 billion over a five year period.
Ben Dillon, CEO of Polartechnics said, "Polartechnics has been exploring the optimal pathway to a commercial launch of CerviScreen for a while. Combining forces with Healthscope and Genera Biosystems provides a solid foundation for CerviScreen's success. Gribbles Pathology is already experienced in running the PapType test, and provides a high quality "back end" to the CerviScreen product offering."
Dr. Keith Byron, Head of Molecular Diagnostics at Gribbles Pathology endorsed this view. "We're very pleased to be working with Polartechnics and Genera Biosystems to help a large group of women access important health services" he said. "Gribbles Pathology has a track record in the introduction of novel healthcare solutions, and this particular initiative is highly significant".
Subject to the completion of a small clinical study, and appropriate regulatory clearances, CerviScreen is expected to be commercially available in Australia in the first quarter of 2009, with a roll-out in South East Asia and Europe to follow later in the year. Other jurisdictions could follow and discussions with potential distributors in a number of markets are in progress.
Allen Bollands, CEO of Genera Biosystems, believes that the potential market for CerviScreen is very significant. "In the USA for example, sixty to eighty percent of women with newly diagnosed cervical cancer have not had a Pap smear for five years. The result s from a CerviScreen test could significantly reduce the number of women that miss out on the benefits conferred by Pap screening".
In the future, Ben Dillon expects Polartechnics to be able to offer additional tests, based upon the CerviScreen model. "Once the woman has taken a specimen, we can perform a variety of tests for other sexually transmitted diseases, such as Chlamydia and Gonorrhoea, as well as HPV" he said. "Polartechnics is working with Genera Biosystems who is developing tests for these other diseases, which we eventually plan to use to broaden the CerviScreen test menu".
About cervical cancer
Cervical cancer is the third most common cancer worldwide and, for women, the second most common after breast cancer. Each year there are about 466 000 new cases globally, and around 232 000 women die of cervical cancer. In 2004, there were 718 new cases in Australia. Virtually all cases of cervical cancer are caused by high-risk HPV. Gen i tal HPVs are the commonest sexually transmitted viral infection.
About Genera Biosystems
Genera Biosystems Limited (ASX:GBI) is a molecular diagnostics company that develops, manufactures and distributes advanced molecular diagnostic tests. Its first product, PapType, a test which simultaneously detects and genotypes Human Papillomavirus, is on sale in Australia through Healthscope. International registrations are expected in 2009. The company has a development pipeline of products including novel tests for Chlamydia trachomatis, and Neisseria gonorrhoea.
About Healthscope Ltd
Healthscope Ltd (ASX:HSP) is one of Australia's leading private healthcare operators. Their reach of facilities around the country firmly places Healthscope as the second largest private hospital provider. Healthscope owns or manages 45 medical/surgical, rehabilitation and psychiatric hospitals. In addition, Healthscope operates a leading pathology business with facilities in Australia, New Zealand, Singapore and Malaysia. The company was formed in 1985 and listed on the Australian Stock Exchange in 1994.
About Polartechnics Ltd
Polartechnics Ltd (ASX: PLT) is a biomedical company s pecialising in screening for cervical and skin cancers. Together with CerviScreen, Polartechnics has developed and manufactures TruScreen, a real-time point of care cervical cancer screening device with superior performance sensitivity than Pap and related cytology methodologies. TruScreen is CE accredited and is used commercially in Asia, Middle East and Eastern Europe. Polartechnics also markets MediScan(tm), a real-time medical record system, for merging visual and text data and SolarScan, a cancer-screening device for melanoma detection.
SOURCE: Polartechnics Ltd