Caldera says third study of PSA-test alternative shows high ability to spot Prostate cancer

Caldera Health, a New Zealand biotech company working on a gene-sequencing replacement for the world's most widely used prostate cancer test, says its third clinical test has shown a strong ability to identify prostate cancer and screen out those who test negative.

The company is working on a replacement for the widely used PSA blood test with a simple "pee in a pot" test, using RNA biomarkers. 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.

The company says its clinical study 2B was completed in July with 157 samples analysed using the gene signatures developed in its earlier clinical study 2. The study will be bulked out with another 100 or so samples, it said.

The 'panel of genes' could identify prostate cancer "with a sensitivity of 96 percent (percentage of patients with disease who test positive) and a specificity of 99 percent (percentage of patients without disease who test negative)," Caldera said in a statement. "This result is significantly more accurate than the PSA-antigen blood test."

The company is now developing a prostate cell capture device that can isolate the prostate cells away from other cells present in the urine. "We will then apply our accurate gene signature that we have developed. We hope to finalise our proof in principle devices before the year's end and a prototype early 2017."

A proof-of-principle device will then be extensively tested with a larger number of clinical samples, followed by the development of a clinic-ready system that could be introduced and used in clinical practice, it said.

After that, "we will seek a partner in the form of an established multi-national diagnostic company that has the resources required to take the device through the regulatory pathways before ultimately bringing it to the market". Caldera "needs ongoing investment from angel investors, venture capital firms and a partner in order to get to this point".

Caldera Health conducted its first trial in 2014 using stored tissue from men who had had their prostate removed. The company now has enough tissue to complete its next study. 

Investors so far include the NZ Venture Investment Fund, the Mercy Ascot Health group, and Stephen Tindall's K1W1 investment company.

(BusinessDesk)

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