21 April 2015
The Australian Financial Review
Copyright 2015. Fairfax Media Management Pty Limited.
Biotechnology company Minomic has developed a simpler, more accurate blood test for diagnosing prostate cancer, which could reduce the number of men who go on to invasive follow-up tests and suffer plenty of heartache after receiving an initial "false positive" result.
Although they are widely used, the standard prostate-specific antigen [PSA] tests have been problematic diagnostic tools. In six out of 10 cases where the tests identify elevated levels of PSA, it is due to a cause other than cancer or the presence of a cancer that is benign and does not need to be treated. Many of those patients who receive an initial false positive result go on to have multiple follow-up tests and, in some cases, invasive biopsies before the initial diagnosis is debunked.
However, data released on Monday from a clinical trial the company undertook in the US shows Minomic's test only returns a false positive rate of 1.5 out of 10. Minomic, which is backed by Mark Carnegie's venture capital fund, has developed the MiCheck test that screens for three biomarkers found on prostate cancer cells. The company originally identified one biomarker, but the study has also provided validation of two additional biomarkers never before used in prostate cancer diagnosis.
Chief executive Brad Walsh said the 300-person clinical trial, which compared Minomic's test in healthy men, prostate cancer sufferers and a group with benign prostate cancer, gave the company sufficient evidence to apply for regulatory approval in Europe.
"By the end of the year, we are looking to roll out products," he said.
Once Minomic has received the European CE Mark for its MiCheck test, it will use that to push ahead with Australian approval, too.
"Australia is a very small market," Mr Walsh said. "We need to kick off in a bigger market first."
To apply for regulatory approval in the US, Minomic will need to do a larger clinical trial with 1200 subjects. "Half of the prostate cancer testing in the world is done in the US," he said.
To fund that trial, the company is on the capital raising trail in an attempt to raise $5 million from wealthy backers.
Since it was established in 2007, when Mr Walsh licensed technology first developed in labs in Sydney's Prince of Wales hospital, Minomic has raised $14 million all up.
The company is unlisted and has about 200 shareholders, who are mostly rich individuals and family offices. The 10 largest shareholders control about 70 per cent of the company. Mr Carnegie's fund, M.H Carnegie & Co, controls about a quarter of the company, while Mr Walsh has a stake worth about 7 per cent.
Mr Walsh said $5 million in funding would last Minomic "until commercialisation". The plan was to strike a licensing and distribution deal with a pharmaceutical or diagnostic company. Looking further ahead, Mr Walsh said Minomic planned to target the specific biomarkers it had identified to create drugs that treat prostate cancer, as opposed to just diagnosing it.
Prostate cancer is most common cancer in Australian men (excluding non-melanoma skin cancer), accounting for 30 per cent of all new cancers in men in 2010. The diagnostic tests will be manufactured in Melbourne by an external company.