Singapore, Jul 30, 2009: Australian diagnostics company HealthLinx obtained CE approval for its OvPlex ovarian cancer diagnostic test, clearing the regulatory path for sales to begin in the United Kingdom and Ireland with immediate effect. This news follows the distribution licence agreement HealthLinx announced it had signed with Intus Healthcare Limited in February.

The release noted that OvPlex is the world’s first and most accurate commercially-available early stage ovarian cancer diagnostic test for symptomatic women with a 92 per cent diagnostic efficiency. The diagnostic is based on a simple blood test that women can request from their doctors.

The launch into the UK marks the first time that OvPlex will be available for commercial sales outside of Australia.

“This is substantial commercial progress for HealthLinx and an important development for women’s healthcare in the UK. Given the profound advantages of early detection of ovarian cancer, OvPlex may save many thousands of lives,” says Nick Gatsios Managing Director of HealthLinx.

Martin Heller, Managing Director of Intus Healthcare said, “The EC Declaration of Conformity we signed as HealthLinx’s Authorised European Representative states that OvPlex meets the provisions of the relevant European Directive and can now therefore be freely marketed anywhere in the European Union. Our initial distribution focus will be the UK and Ireland.”

OvPlex was first released by ARL Pathology in the Australian market in October 2008 under licence from HealthLinx. The test was developed in Melbourne by HealthLinx scientists and uses five protein biomarkers found in blood. The test delivers superior diagnostic efficiency and out performs any other commercially-available ovarian cancer test.

Worldwide over 240,000 new cases of ovarian cancer are diagnosed each year while more than 130,000 women die from the disease. The UK region accounts for over 7,000 of these diagnoses and 4,000 lives lost.

Ovarian cancer is the most lethal of the reproductive tract cancers. 75 per cent of women with ovarian cancer are not diagnosed until late stage disease. Their chances of surviving five years are probably only 20-30 per cent. But if the disease is diagnosed at early stage where it is contained within the ovary the chance of surviving five years rises to 80 per cent.

 

HealthLinx is continuing development on the OvPlex panel to further improve accuracy to greater than 97% diagnostic efficiency.