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VALIDATION

 

KAPS Biotech LLC was founded to develop, publish and to bring to market a unique panel of biomarker(s) for the early detection of PCa that can inform PCa treatment decision making and improve monitoring men with PCa. The biomarkers have been developed and the initial findings have been published in the scientific literature. Investors are being sought for additional research needed to prepare the technology for FDA approval and to bring the technology to market. 

 

Sudhir Srivastava, PhD, MPH, the founding Chief of the Cancer Biomarker Research Group at the NCI “highlighted 3 hurdles that have historically held back biomarkers progress: a lack foundational studies, a lack of sustained funding, and a lack of quality biological samples for testing.”1-3

 

 

The development of biomarker typically passes through 5 phases

  • Preclinical exploratory studies

  • Clinical assay and validation

  • Retrospective longitudinal studies

  • Prospective screening studies

  • Randomized control trials

 

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