The Business Plan
The laboratory cost for a Pap test is more than $50 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 65 million tests per year.
Pap test inadequacies, healthcare cost controls, the need for clearer presentation of test results, the momentum of patient-centered care, and the movement to integrated healthcare will force innovation in cervical screening.
The bioprobe tip can be modified to include a guide tube for biopsy. This product could be quickly trialed and marketed to colposcopists to provide accurate positioning for tissue biopsy. In addition, the device would provide tissue analysis that could target other areas for biopsy. This initial system would also gather data for clinical trials of the Pap test replacement system.
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 $1600. 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 could 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.
The worldwide potential for cervical testing is 1 billion a year, assuming retesting every two years. 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 locally and provide regional leadership and influence for a country such as South Africa, for example. Non-governmental aid agencies are seeking precisely such devices.
