Mediscience to start cervical cancer pilot study

By Elaine Rigoli

Tampa, Fla., April 3 - Mediscience Technology Corp. said Monday that the Food and Drug Administration has approved a multi-center pilot study to establish the safety and parameters of efficacy of its proprietary optical biopsy device (CD-R) for cervical-cancer detection.

The main objectives of this pilot study are to determine efficacy; the clinical sensitivity and clinical specificity by comparing real-time results to the PAP test and biopsy; and assess any adverse events based on good clinical practices, according to a news release.

Frequency, type and intensity of clinical adverse events will also be evaluated, the release said.

Assuming the results of this initial efficacy and safety study are satisfactory, the company said it will continue into its pivotal study where the principal endpoint will be proof of effectiveness in a statistically significant sample of subjects.

"This FDA approval advances Mediscience to the next level toward commercialization and is a major step in advancing diagnostic medicine using fluorescence light. Alfanix plans to help Mediscience with its CD-R platform technology in the medical cancer areas and possibly expanding the market into Latin America," said Robert Alfano, a co-founder and adviser to Mediscience Technology and president of Alfanix Ltd., in a statement.

Mediscience, based in Cherry Hill, N.J., develops medical devices that detect cancer and physiological change using frequencies of light that are emitted, scattered and absorbed to distinguish malignant, pre-cancerous or benign tissues from normal tissues.

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