A Medical Device Daily

The FDA and SpectRx (Norcross, Georgia) reported that it has held "preliminary" meetings concerning premarket application PMA approval for its non-invasive cervical cancer detection product, currently in testing. The company said that the meetings were designed to ensure that the data, data format and documentation of its application will meet the expectations of the agency and its advisory panel.

SpectRx said the test uses proprietary technology to identify cancers and precancers painlessly and non-invasively by analyzing light reflected from the cervix. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the test does not require a tissue sample or laboratory analysis and results are available immediately.

It said that, to date, more than 2,000 women have been tested with prototypes of the device, designed to reduce unnecessary biopsies by 55%, according to results of a study published in the January 2007 edition of the Journal of Lower Genital Tract Disease.

Mark Faupel, SpectRx president/CEO, said, "As we work toward completing subject enrollment in the pivotal trial, we expect to receive continuing guidance from the agency on . . . how test results should be presented to physicians, how to present clinical trial results for review, how to structure the application for premarket approval and plans for post-market surveillance."

SpectRx is developing monitoring and treatment solutions for the diabetes and cancer markets.