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LuViva® Advanced Cervical Scan, under development by Guided Therapeutics, is designed as a new non-invasive test that has the potential to significantly improve the early detection of cervical precancers. LuViva is designed as a fast, painless test that - unlike Pap smears and HPV testing - does not require a tissue sample or the delay of laboratory analysis. Early detection of cancer and precancers greatly improves survival, and LuViva is designed to help preserve the reproductive health of women.

LuViva uses proprietary technology to identify cancers and precancers quickly 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.

More than 1,600 women at risk for cervical disease were tested with the LuViva in a multi-center pivotal clinical trial. Results of the trial showed that:

  • LuViva detected cervical disease up to two years earlier than Pap test, HPV test, colposcopy and biopsy.

  • LuViva detected 86.3% cervical disease cases that had been missed by Pap, HPV (human papillomavirus) tests and biopsy.

  • LuViva would have reduced the number of unnecessary biopsies by about 40 percent.

Additionally, Guided Therapeutics’ clinical trial indicated that women aged 16-20 were just as likely to have cervical disease as women 21 and older and current methods of early detection, such as HPV testing, are not recommended for this age group. LuViva detected cervical disease equally well in both adolescent and adult women.

According to published reports, cervical cancer is the third most common cancer among women worldwide. Globally, there are approximately 471,000 cases of cervical cancer diagnosed annually and approximately 233,000 deaths per year. Approximately 60 million Pap tests are performed annually in the United States.

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CAUTION - Investigational device. Limited by federal law to investigational use. The availability of any product in the U.S. developed from these technologies is dependent on FDA marketing approval. Global market availability is dependent on additional regulatory approvals.



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