The Business Plan
The preliminary bioprobe could be marketed to provide mapping and monitoring of the cervix. This system would be upgraded with diagnostic assist, screening capability, and finally stand-alone diagnostic capability to replace the Pap test as FDA approval is secured. The kit and laboratory cost for a Pap test is more than $40 even under a managed healthcare system. Since the bioprobe eliminates the lab work, the disposable tip for the Pap replacement product could sell below the cost of that lab work while providing immediate results, improved accuracy, and feedback on technique. The US market for the Pap test is about 55 million tests per year.
The first phase of development will produce prototypes for the cervical tissue mapping system and will also refine the initial software to control the electronics and display the results. This development will facilitate strategic alliances and additional funding for the second phase development. This second phase will then involve clinical trials and development of the diagnostic algorithm.
The large scale marketing of the products could proceed through alliances with large healthcare-insurer networks. The Preciva products would reduce cost and minimize retesting for ambiguous results. Such follow-ups normally involve colposcopy and the US cost then averages $1500. Managed healthcare systems are motivated to minimize such procedures and are natural allies. Likewise, the tissue mapping information would allow tracking of lesions over time so that the normal processes of regression can be monitored and surgical intervention reduced. Other features of the Preciva products, such as immediate results and patient involvement, are desirable for such healthcare providers.
Obtaining a CE mark for European distribution can be completed more quickly than FDA approval. The CE mark process would involve the same third-party certifier that would be used to expedite the FDA process. While the most profitable applications of this product reside in high income countries, this project could also create a new business sector for the economy of a low income nation. Such local technology would then attract related business and build an infrastructure for other clean technologies and a health services industry. The product itself could then be manufactured and refined in low income countries and provide regional leadership and influence for a country such as South Africa, for example. Non-governmental aid agencies are seeking precisely such devices.