Alice Goodman

May 31, 2011

May 31, 2011 (Washington, DC) — A novel noninvasive scanning device that uses spectroscopic technology promises to improve the detection of cervical dysplasia in patients with abnormal Pap tests.

The LuViva Advanced Cervical Scan was able to detect cervical disease as much as 2 years earlier than traditional methods, including Pap testing, human papillomavirus (HPV) testing, colposcopy, and biopsy, according to a longitudinal pivotal clinical trial presented here at the American Congress of Obstetricians and Gynecologists 59th Annual Clinical Meeting. The device is in the late stages of review for US Food and Drug Administration (FDA) approval.

Cervical cancer rates are on the rise in the United States; according to American Cancer Society statistics, they have increased by 26% in the past 5 years. Standard techniques are inadequate; colposcopy misses anywhere from 30% to 40% of cervical cancer, and Pap tests can detect it only 5% to 10% of the time, said Leo Twiggs, MD, from the University of Miami Miller School of Medicine in Florida.

"LuViva is a technological advance that identifies precursors to invasive cervical cancers by measuring the spectral output of cervical tissue [changes in light relative to depth]. The device takes about 1 minute to reflect light changes in cervical tissue," he explained.

Dr. Twiggs and colleagues enrolled 1607 women at 7 clinical centers in the United States who were referred for LuViva after an abnormal Pap test or other findings suggesting endometrial abnormality. In addition to LuViva testing, all subjects were slated to undergo another Pap test, a colposcopy, and a biopsy.

Dr. Twiggs presented 2-year follow-up data on 801 women 16 to 31 years of age who had undergone a colposcopy within the previous 2 years; each subject served as her own control.

LuViva detected cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in 91% of patients, compared with standard care (i.e., PAP test, HPV test, colposcopic exam, and biopsy), which detected 76%. Thus, the device increased the detection of CIN2+ by 20%, Dr. Twiggs noted. He referred to these as "rule in" results.

No further testing was required in 39% of patients after LuViva; after standard care, no further testing was required in 30%.

For "rule out" results, he said LuViva would have reduced the number of false-positive tests by 39% in women with normal histology and by 30% in women with low-grade dysplasia (CIN1).

LuViva is noninvasive and does not require a tissue sample or laboratory analysis. Results are available within minutes. The test is painless, portable, and easy to use, Dr. Twiggs noted.

The device is not intended to replace Pap testing, he cautioned. "Patients with an abnormal Pap test would be referred for LuViva as an intermediary stage," he said.

Dr. Twiggs said that the pricing has not yet been established. "This device may reduce cost because it reduces unnecessary testing. We will do cost-effectiveness studies once the device is approved by the FDA," he explained.

"This device would take human error out of the picture," said Kevin Ault, MD, associate professor of obstetrics and gynecology at Emory University School of Medicine in Atlanta, Georgia. "Humans are fallible, and that includes in the reading of colposcopy after an abnormal Pap test to get areas for further study."

Dr. Ault said that cost would be an important factor to consider. "Colposcopy is not cheap; the scope costs a few hundred dollars. But physician costs are high, too," he noted.

The study was partly funded by the National Cancer Institute and Guided Therapeutics. Dr. Twiggs reports financial ties with Merck, GlaxoSmithKline, and Hologic. Dr. Ault has disclosed no relevant financial relationships.

American Congress of Obstetricians and Gynecologists (ACOG) 59th Annual Clinical Meeting. Presented May 2, 2011.

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