Forum Summary

Developing new biomarker technology is a long and arduous process, hopefully culminating in successful commercialization.  At all points along the way, efforts must be made to augment the perceived value of one’s company, and one must recognize that value creation in the biomarker industry often proceeds differently than in other biomedical industries.  The typical pathway of development for a new diagnostic marker includes company formation, proof-of-concept studies, clinical validation, regulatory approval, and market adoption.  Since 2008, when the availability of venture capital funding decreased sharply, the value of a new biomarker company stays relatively constant until the company approaches the commercialization stage.  Validation studies no longer create large inflection points in terms of value.  A new biomarker can take five to ten years to penetrate a market, requiring an investment of fifty to one hundred million dollars, so if a start-up company is to attract early investment, it must quickly develop a long-term economic plan.

Predictive Biosciences is an example of a company in the process of commercializing new biomarker technology.  It focuses on the detection of bladder cancer, a highly recurrent cancer usually diagnosed through an invasive procedure.  Using protein and molecular DNA markers, Predictive Biosciences has developed a way to detect bladder cancer with high sensitivity and specificity.  The company implemented good manufacturing protocols from the beginning so that it could quickly move its product into clinical use after winning approval.  It also increased its value to investors by acquiring an existing urology-focused anatomic pathology company.  This acquisition gave Predictive Biosciences a readymade delivery network for its new diagnostic products and created a revenue stream, mitigating risks for investors.  Creating a revenue stream and distribution network made the company more attractive to venture capitalists.   

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