Development and Testing

The probe tip itself is less than one inch (25mm) in diameter. This means that rapid development requires precision machinery to produce various configurations for testing. Preciva has purchased computer-controlled equipment which provides the capability to quickly test engineering designs by building prototypes. This machinery can also supply initial production quantities of disposable tips.

The electrode spacing, electrode size, and frequencies of the initial design are suitable for detecting structures down to the basement membrane.  Various configurations will be built and tested comparatively on tissue substitutes and directly on tissues. These prototypes will be compared in order

to optimize such parameters as electrode width and spacing, overlap of readings, frequencies used, and shape of the tips to best fit the contour of the cervix. When prototype design has been finalized, and with adequate financing, hard tooling and molding equipment will be obtained to lower manufacturing costs and generate high production quantities of the disposable tip.

For clinical trials, large healthcare-insurer networks could support the clinical trials by covering the cost of HPV testing, Pap testing, colposcopy, and biopsy.  Related gynecological product trials have been recently supported by such networks.