Ovarian cancer test comes under fire MARY-ANNE TOY July 5, 2010
DOCTORS, researchers and a leading women's cancer body have attacked a ''revolutionary'' $200 ovarian cancer test developed by a Melbourne biotech company because they say there is no proof it will save lives.
Melbourne company Healthlinx, which launched the OvPlex ovarian cancer test in October 2008, recently won a $750,000 state government grant to improve the test's accuracy. It is recommended for women who already have symptoms of ovarian cancer, which kills 800 Australian women a year.
The test has just been launched in Britain and Singapore and the company is aiming for a big slice of the $US270 million-a-year market. But the National Breast and Ovarian Cancer Centre and Cancer Australia do not recommend its use because they claim there is not enough evidence it works. Researchers and doctors say that only one study of OvPlex has been done and there is no data to show the test improves survival rates - and that it could create uncertainty and unnecessary surgery.
Advertisement: Story continues belowOvarian cancer is known as the ''silent killer'' because by the time symptoms show it is often too late. Two-thirds of women told they have ovarian cancer die within five years.
Healthlinx, an ASX-listed biotech company, launched the OvPlex test on the basis of a then-unpublished study showing it was better than the standard blood test CA-125.
The test is recommended for women who already have cancer symptoms - but some experts argue that by that time chances are the disease is already advanced.
Healthlinx's co-founder and board chairman Professor Greg Rice concedes there is no evidence that OvPlex can save lives but argues that because it is more accurate than CA-125 it is a better diagnostic tool and worth $200.
''The one study that has been done with OvPlex has been done appropriately and the findings are scientifically sound. It's a better test than CA-125,'' he said.
He says there are 90,000 CA125 tests done each year in Australia. ''We have a better test, why wouldn't you use it?
''When a woman has a low CA-125 and a high OvPlex result, you will be followed up sooner, which is better because it increases the chances of successful treatment.''
The National Breast and Ovarian Cancer Centre and Cancer Australia disagree. The chief executive of both organisations, Helen Zorbas, told The Age: ''It is important to note that no data on OvPlex have been reported from prospective controlled clinical trials and there is currently no evidence that OvPlex has any impact on ovarian cancer mortality.''
Further studies were required to determine whether OvPlex and similar tests had a role in clinical practice, she said.
In the multibillion-dollar pharmaceutical industry, finding cures for disease is the ultimate goal. Healthlinx, however, is focused on diagnostic tests because they are easier and cheaper to get to market.
The one study done on OvPlex used 362 samples from women with ovarian cancer and healthy controls and was published by the Journal of Cancer Research Clinical Oncology this year. But some experts say large trials involving thousands of women are needed to determine whether OvPlex has a role in clinical practice.
Professor Michael Quinn, one of Australia's leading researchers and gynaecological oncologist at the Royal Women's Hospital and the University of Melbourne, refused to have his name on the OvPlex study published in January, even though he was involved.
OvPlex was a most promising test, but he disagreed with it being sold before further studies were done, he said. ''It was a small study that's never been validated by another group; there is no study to see if it actually altered the outcomes for patients.''
Associate Professor Peter Grant, of the Mercy Hospital, says the single OvPlex study does not prove that the test improves a woman's chances of surviving ovarian cancer. ''They can't produce any data or evidence to say that is the case.''
A negative or normal result might falsely reassure a woman that she did not have cancer - and a high OvPlex result could trigger ''an extraordinary number of unnecessary interventions''.
''I have seen quite a number of women who have come to me in the past 18 months with high OvPlex tests [results] who are worried out of their brain. In no case have I found an ovarian cancer.''
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