Novel Scanning Device offers Rapid Detection of Cervical Cancer and Precursors

Washington, DC—A novel scanning device for detecting cervical dysplasia in patients with abnormal Pap tests was described at the 2011 meeting of the American College of Obstetricians and Gynecologists, and is now under review by the US Food and Drug Administration.

The LuViva Advanced Cervical Scan is a noninvasive and painless test that identifies precursors to invasive cervical cancer by measuring fluorescence and reflectance spectra (changes in light relative to depth). The cervix is viewed via a live video feed that is inserted through the speculum.

Unlike the Pap test and tests for human papillomavirus (HPV), the LuViva Scan does not require a tissue sample or a laboratory analysis, and the results are available within minutes. Leo Twiggs, MD, of the University of Miami Miller School of Medicine, FL, noted that cervical cancer rates have increased by 26% within the past 5 years. He said that the standard tests (ie, Pap smear, HPV testing, and colposcopy) are inadequate for identifying all cervical cancer cases.

Colposcopy misses up to 40% of cervical cancers, and Pap smears detect only 5% to 10% of cases. Dr Twiggs and colleagues enrolled 1607 women at 7 clinical centers for their study with the LuViva Scan. These women were referred after abnormal Pap smears or other abnormal endometrial findings. All the women underwent a second Pap smear, colposcopy, and biopsy in addition to the LuViva Scan.

At the meeting, Dr Twiggs presented the 2-year follow-up data of 801 women who underwent colposcopy within the past 2 years; each subject served as her own control.

Cervical spectroscopy by the LuViva Scan detected cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in 91% of the women compared with 76% with standard tests. This translated to a 20% improvement in the detection of CIN2+, he noted.

Based on these outcomes, the use of the LuViva Scan would reduce the number of false-positive test results by 39% in women with normal histology and by 30% in women with low-grade cervical dysplasia.

“This would translate into significant cost-savings to patients and the healthcare system,” Dr Twiggs said. “Cervical spectroscopy improves the detection of high-grade dysplasia and eliminates unnecessary colposcopy and biopsy. The test is relatively simple and not uncomfortable, and it is well accepted by patients.”</p>