Ahead of its pivotal trial data — a trial targeted, but not guaranteed, for completion later this year — SpectRx (Norcross, Georgia) said its non-invasive test for cervical cancer was more effective at correctly identifying cervical disease from normal tissue than Pap and Human Papilloma Virus (HPV) combination testing, according to results of a study published in April.

The study was published in the peer-reviewed Journal of Lower Genital Tract Disease, which is a publication from the American Society for Colposcopy and Cervical Pathology (Hagerstown, Maryland).

The device, which uses light to scan the cervix for disease, may one day become a routine part of gynecological annual examinations, much as the Pap test is standard and more recently, many doctors also test for HPV simultaneously. HPV has been shown through studies to be the necessary precursor to cervical cancer.

SpectRx president/COO Mark Faupel, PhD, noted in a statement that "Large studies, published this year in the Journal of the American Medical Association (JAMA), show that the prevalence of HPV in the general population is higher than previously thought, indicating greater need for a new test to determine quickly and accurately these women who actually have disease vs. those who do not."

Faupel told Medical Device Daily that its device, which enables the test, is not really a competitor to the Pap test.

"A lot of women are being referred to colposcopy and biopsy because they have a positive HPV test, so they can have a normal Pap test or an abnormal Pap test," he said. "In the group of women that are being referred for biopsy, our test would be able to rule out a much higher percentage of those women and keep them from going on to those expensive, anxiety-producing and unnecessary procedures."

In the study, the authors, for example, cite other research that suggests "HPV testing is an indirect marker of neoplasia, and the positive predictive value of a positive HPV test is approximately 16%, because of its high prevalence in the general population, especially in women with abnormal Pap tests and in younger women."

The current study, which was conducted prior to the beginning of the pivotal trial now under way, may still be considered by the FDA as the company advances to what it hopes will be a submission to the FDA in early 2008. Faupel said that there are many variables on which the timing of its submission hinges, such as the number of disease cases in the population.

"In general, we feel we have on the order of several months to go of enrollment . . ." Faupel told MDD.

In this study, for which Faupel is cited as one of the authors, the technology was tested on 102 women with abnormal Pap tests scheduled for colposcopy and biopsy at the University of Texas Southwestern Medical Center (Dallas). The study compared the results of a Pap test combined with the SpectRx test the results of a Pap test combined with HPV test. That, Faupel said, is the "same protocol" being followed in its pivotal trial.

The sensitivity, or the ability to accurately detect cancer, of both tests was 95%. However, the specificity, or the ability to accurately detect benign or healthy tissue, of the Pap/SpectRx test was 65.5% vs. 27.4% for the Pap/HPV test.

The device is used to shine light on the cervix, and then that light is analyzed. The device distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. The light is reflected on a spectrometer immediately, so there is no waiting, and that device responds by telling the physician if the results are normal or abnormal.

Unlike Pap or HPV tests, SpectRx's test does not require a tissue sample or laboratory analysis, since the device sits to the left or right of the examining physician. The company said that to date, more than 2,000 women have been tested with various prototypes of the detection device.

The test is being commercialized by SpectRx's subsidiary, Guided Therapeutics.

SpectRx said that according to published reports, cervical cancer is the second most common cancer, after breast cancer, among women worldwide and the third most common overall. Worldwide, there are about 471,000 cases of cervical cancer diagnosed annually and about 233,000 deaths per year. About 60 million Pap tests are performed annually in the U.S.

In March, SpectRx reported that it planned to restructure the company, with that restructuring including an exit from the insulin pump business and placing its focus entirely on the cancer detection technology (Medical Device Daily, March 16, 2007).

That plan to reorganize follows the restructuring of $4.7 million of its debt into three-year convertible notes, the company said at the time. Also as part of the reorganization, the company said it would sell its SimpleChoice insulin pump infusion set business in order to raise additional capital needed for the cervical cancer program.

Earlier this month, SpectRx CEO/chairman Mark Samuels reported that he plans to retire this year, effective with the appointment of a successor, but will remain a company director (MDD, April 17, 2007).

In January, SpectRx reported that it had held preliminary meetings concerning potential a premarket approval application for its cervical cancer device. 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 the advisory panel (MDD, Jan. 31, 2007).

No Comments