Caldera Health has developed a laboratory test that measures the expression of a range of RNA biomarkers (Caldera’s patented gene signature) to accurately and reliably diagnose prostate cancer.

Based on the 97% accuracy achieved in our tissue signature, a potential of 441 fewer unnecessary biopsies would be performed using the Caldera test (CAL) versus PSA, as simulated below.

Caldera started Clinical Study 3

Caldera started Clinical Study 3 (CS3) in late October 2017. CS3 will compare urine and matched tissue samples so that we can transition our tissue gene signature to a non-invasive urine sample. In tissue, our biomarkers and algorithm had a sensitivity of 97% and a specificity of 97%, CS3 will allow us to develop a urine signature and algorithm, and confirm the new sensitivity and specificity in urine.

To achieve this goal

Caldera has developed standard methods for the isolation of extracellular vesicles present in urine, a rich source of RNA. The RNA is then isolated from the vesicles and used for analysis of the patented gene signature by standard PCR techniques.

Caldera hopes this novel urine test will provide the same level of accuracy as shown using biopsy tissue, with a less invasive test process than the PSA test.

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