Caldera Health, a New Zealand biotech company working on a gene-sequencing replacement for the world's most widely used prostate cancer test, is seeking more biopsy samples from Kiwi men to help prove its concept.
Caldera managing director Graham Watt said he wants at least 50 samples by the end of the year though would eventually like to build up to at least 200 to help prove the credibility of its proprietary gene-sequencing test.
The medical diagnostic firm has been receiving a few samples by working in conjunction with Auckland urologists, but Watt said it's not sufficient for its needs and is now asking men throughout New Zealand to also give their permission for the company to be sent a slither of their biopsy sample when they're presenting with possible prostate cancer.
Caldera Health conducted its first trial last year, using stored prostatectomy tissue from men who had had their prostate bladders removed. Watt said live tissues are also needed to help test the biomarkers for the gene sequencing.
The company plans to replace the controversial PSA blood test with a simple "pee in a pot" test. The urine would be tested for RNA biomarkers.
"We have done enough to know the urine test is possible but for our test to stand up in the medical world we need to further validate our biomarker panel from many more biopsy samples," Watt said.
The company hopes to have enough data by the first quarter of next year to approach an international medical company about licensing the technology.
"There's an unmet clinical need and a big commercial opportunity," he said.
In 2012, the US Preventive Services Task Force recommended against mass PSA screening because it threw up both false positives and negatives, didn't distinguish between aggressive cancers and benign strains or even other prostate conditions, and led to over-diagnosis and unnecessary prostatectomies.
Caldera's alternative is based on the use of RNA biomarkers to distinguish between healthy and cancerous tissue. The stage 2 clinical study currently under way is to demonstrate that the genetic biomarkers correspond with what is known as a Gleason score, where prostate tissue from a biopsy is rated on the level of 'disorganisation' of cells, a cancer indicator used alongside the PSA that's also regarded as limited because it can't detect whether a cancer is aggressive. If and when a Caldera test is developed, it would be used alongside the Gleason score.
Caldera Health has so far raised $1.2 million of the $2 million sought in its latest offer of 2.5 million shares at 80c apiece. Caldera will sell about 23 percent of the company in this funding round, lifting total shares outstanding to 11.1 million and valuing the firm at $8.9 million.
The money will be used to accelerate its clinical studies and put the research in front of commercial partners. It has attracted $5.93 million since it was founded in 2009 by the late Richard Foster and Jim Watson, who's now an advisor to the company due to ill health.
Investors include the NZ Venture Investment Fund, the Mercy Ascot Health group, and Sir Stephen Tindall's K1W1 investment company.
Watt said the $2 million capital would last until early next year when the company would likely seek offshore investors because it would be "further down the track in proving the data is credible" and, in part, because it has already tapped a lot of local investors and will still need significant amounts of funding.
The RNA biomarker analysis can also be used to test for other cancers, including breast cancer, said Watt, a former executive with Roche Diagnostics. "This is not a one-trick pony."
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