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Mediscience seeks FDA OK to begin trial of cervical cancer diagnostic device
By Angela McDaniels
Seattle, Jan. 5 - Mediscience Inc. said it has filed an Investigational Device Exemption Application with the Food and Drug Administration so that it may begin a human clinical pilot study of its Cervical Cancer Detection Radiometer.
Through the study, Mediscience aims to demonstrate the device's ability to distinguish between tissues that are normal, benign, low-grade precancerous, high-grade precancerous and cancerous. The results will be compared to each patient's PAP test and tissue biopsy and will be evaluated for clinical adverse events.
Once given FDA permission, the multi-center pilot study will enroll 400 patients. Two groups of 50 to 75 patients each will be tested to define the spectral characteristics of the normal and cancerous cervix. The remaining population will be tested to define intermediary states between normal and various stages of cancer.
"This anticipated pilot study ... brings the company one step closer to commercialization of its broad, patented optical biopsy technology platform applications," chairman Peter Katevatis said in a company news release.
The company is also developing the Compact Photonic Explorer, or "pill camera," with New York-based research consortium Infotonics Technology Center Inc. The ingestible photonic pill would allow physicians to detect early stage cancer of the auto-digestive tract using Mediscience's embedded optical biopsy technology platform, the company said.
Mediscience is based in Cherry Hill, N.J., and designs, develops and commercializes medical devices that aid in the molecular diagnosis of cancer and physiological change.
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