cerviscreen announcement

New announcement ... it appears there's finally movement for Cerviscreen, but sharing slices of the pie ... although with some quality big-hitters who would have otherwise been competitors:-

Announced at 10:10am ...

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Polartechnics Limited ("Polartechnics") is to develop and launch its CerviScreen in close collaboration with Genera Biosystems Limited ("Genera Biosystems") and Healthscope Limited ("Healthscope")

Sydney, 5th September 2008

• CerviScreen uses a new Human Papillomavirus (HPV) DNA test incorporating an innovative self-sampling device, designed and developed by Polartechnics that will
improve cervical cancer detection rates by targeting the significant proportion of women internationally who do not currently access Pap smear services.

• Polartechnics proposes to launch CerviScreen in Australia, South East Asia and Europe during 2009. These target markets comprise an estimated 70 million nonscreening
women.

• Polartechnics targets new market segment with revenue potential in excess of $3.5 billion over a 5 year screening cycle.

• Polartechnics is collaborating closely with its preferred business partners Genera Biosystems and Healthscope. Genera Biosystems to supply PapType Human Papillomavirus (HPV) detection and genotyping test; and Healthscope to supply
pathology testing services, initially through their Gribbles Pathology laboratories.

Polartechnics today 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. 1

The existence of a persistent level of 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. 2 3

1 Cervical screening in Australia. Australian Institute of Health and Welfare, May 2008.

2 Holanda Jr, F., et al. (2006), 'Primary screening for cervical cancer through self sampling', International
Journal of Gynecology and Obstetrics, vol. 95, pp. 179-184.

3 Hillemanns P, Kimming R, Hüttemann U, Dannecker C, Thaler CJ. 'Screening for cervical neoplasia by self-assessment for human papillomavirus DNA'. Lancet, 1999;354:1970.

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 potential 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 $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 4. The results 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".

4 http://www.medicinenet.com/pap_smear/page10.htm

About Polartechnics:
Polartechnics Ltd (ASX: PLT) is a biomedical company specialising 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 MediScanâ„¢, a real-time medical record system, for merging visual and text data and SolarScan, a cancer-screening device for melanoma detection.

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 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. Genital HPVs are the commonest sexually transmitted viral infection. For more information on HPV and cervical cancer, visit http://www.cervicalscreen.health.gov.au.

Further details:

Ben Dillon,
CEO Polartechnics Limited
Telephone: +61 (0)412 88 20 40
e-mail: [email protected]

Dr Allen Bollands
CEO Genera Biosystems Limited
Telephone: +61 (0)423 943 600
e-mail: [email protected]

Dr. Keith Byron
Head of Molecular Diagnostics at Gribbles Pathology
Telephone: +61 (0) 411 022 109
e-mail: [email protected]

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I'll disclose at this point that I'm also a Genera shareholder, I participated in the recent IPO and have been picking up further stock since then. From what I've read, it appears to be an excellent company with a great testing technology, and if not in partnership with them a stand-alone CerviScreen would have found them a major competitor (although they are not established yet, they will become a significant force from 2009 onwards).

Gribbles I first heard about via Genera, as that's where they did their local testing (and still using them as I understand it). Genera also teamed up with Sonic Healthcare for the US (possibly elsewhere?), I'm wondering if there might be another deal with Polartechnics and Sonic for US distribution in the near future?!

It's good to see some go-forward finally on this product, and it sounds like PLT's keeping to its strength in this area ... the self-collection device. Note the new name 'GenSwab' ... this in itself is an indicator that they're looking to push it as a product, not only for HPV etc. testing (i.e. presumably it stands for 'Genetics swap' ... you'd think).

Hopefully this is a starting catalyst for the SP to head upwards and hopefully keep going in that direction.

Cheers all.