Cervical Cancer Test Has Fewer False-Positives

Results from a clinical study show that prototypes of a biophotonic system of detecting cervical cancer could result in only half the number of false-positives reported from human papillomavirus (HPV) testing. The prototypes also detected 15% more high-grade precancers than Pap tests.

The study was conducted at four leading US clinical centers and involved 274 women. For women who had an ambiguous (ASCUS) Pap test result, the prototype devices provided a very high negative predictive rate of 98%. Based on these results, referral rates for colposcopy and biopsy for women with ASCUS would be less than 30%, compared to 56% for HPV testing. The prototype device uses biophotonic technology to locate cancers and precancers noninvasively by analyzing light reflected from the cervix. The device creates an image of the cervix indicating the location and severity of disease.

The technology differentiates between normal and diseased tissue by detecting biochemical and morphologic changes at the cellular level. Unlike HPV or Pap tests, this test does not require a tissue sample or laboratory analysis. The test was developed by Spectrx, Inc. (Norcross, GA, USA; www.spectrx.com). Pivotal clinical trials are expected to begin in late 2002 or early 2003.




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