MediSpectra (Lexington, Massachusetts) has gotten the FDA green light for its premarket application (PMA) for the Luma Cervical Imaging System, designed to serve as an adjunct to traditional colposcopy.
According to the company, the device is expected to reduce the number of high-grade cervical cancer precursors – or lesions that are at high risk of developing cancer, that are missed when women are evaluated for abnormal Pap tests – an evaluation endorsed by a statement from the FDA reporting the PMA approval.
“With the liquid cytology today, we are [finding] about 7% to 9% of all Paps are abnormal,“ Thomas Wright, MD, consulting medical director for MediSpectra, told Medical Device Daily, adding that “very few“ of those cases are ultimately determined to be cervical cancer.
According to 2006 data from the American Cancer Society (Atlanta), 9,700 cases of cervical cancer are diagnosed each year in the U.S., Wright said.
The device is an optical imaging system located on an “articulated arm“ which is then pulled over and its light shone on the surface of the cervix in conjunction with a colposcopy exam, taking all of about 12 seconds. Then the ob-gyn completes the regular colposcopy exam, determining which areas may look abnormal. However, the ob/gyn checks the Luma for its results, to determine whether he missed any areas that may be precancerous before taking biopsies.
The system scans tissue with a combination of fluorescence spectroscopy, white light diffuse reflectance spectroscopy and video imaging.
“It's an optical analysis system, and it scans the cervix using multiple sources of light,“ Wright said. “And then it has algorithmic processing in order to identify areas of the cervix which are at risk for having high-grade precursors. That's done by the algorithm in the device.“
That “processing“ takes “less than a minute,“ Wright said, noting, however, that it isn't a replacement, but “truly an adjunct to,“ colposcopy.
“High-grade cervical neoplasia, or precancers, as we call them, they have really distinct biochemical – also physical – tissue properties compared to normal tissue,“ he said.
The Luma System was evaluated in clinical trials involving more than 3,500 women by more than 50 colposcopists at 15 clinical practice centers throughout the U.S.
Ronald Alvarez, MD, a principal investigator in the clinical trials at the University of Alabama at Birmingham , said “recent studies have shown that colposcopists can miss up to one-third of high-grade cervical cancer precursors, while use of the Luma System demonstrated a significant increase in the detection of lesions that have a high risk of developing into cancer.“
In the next year, Wright said that MediSpectra will be ramping up to manufacture and market the Luma while simultaneously seeking Centers for Medicare and Medicaid Services reimbursement.
One of the hurdles the company will have to overcome in its marketing efforts is the belief by many ob/gyns that colposcopy already does the job as intended, Wright acknowledged.
“I think if you ask most people performing colposcopy, they would say, 'Yes, it misses a few cases, but pretty rarely,'“ Wright said, but added: “In fact, that's not the case.“
Wright explained that “only over the last 10 years“ have physicians begun to realize that fact.
One bit of evidence comes from a practice begun about 10 years ago whereby physicians started excising cervical tissues using a “wire electrical surgical loop“ on the area at high risk of hyperplasia. Prior to the new practice, much of that tissue would have been ablated, or frozen. But in recent years the tissue has been studied pathologically, and this study has found “there are more cases of high-grade disease detected than were detected using colposcopy.“
Secondly, evidence has come from a large study on how to manage women with “different grades of abnormal Paps“ completed in 2003. In that study, well-trained oncological gynecologists performed the colposcopies; what they found was about a third of high-grade lesions were missed. The women in the study were followed for two years after the procedures.
The perception by most ob-gyns that colposcopy works will require MediSpectra to undertake a strong educational component in its marketing efforts, Wright said. The company will try to make the device the subject of lectures in medical schools and push educational efforts regarding, he said, the “limitations of colposcopy.“
MediSpectra may have yet another challenge on the horizon, as another company, SpectRx (Norcross, Georgia) has a similar device.
In early March, SpecRx reported that it was granted a patent for the “unique method in which its noninvasive cervical cancer detection technology helps to define the location of disease and reduce errors in data collection.“
Mark Faupel, president and COO of Guided Therapeutics , the SpectRx subsidiary company formed to commercialize the detection device, said, “This patent is an important addition to our portfolio of noninvasive detection and monitoring intellectual property. The patent provides for a more efficient method of determining tissue characteristics and may be useful for detecting cervical disease and possibly other cancers as well.“
That device is in pivotal trials in preparation for being presented to the FDA.
SpectRx said the patent claims a device that spectroscopically measures tissue at high resolution while avoiding cross talk, or “ambiguity,“ between measured locations.
“This is done by moving a component of the device and repeating interrogations on a different set of locations of tissue using both fluorescence and reflectance spectroscopy,“ the company said. “The method claimed allows for a short measurement time, thereby reducing potential errors while allowing the use of cost-effective instruments.“
SpectRx also said at mid-month that two clinical studies show it is more effective at determining whether a woman has cervical precancer or a benign lesion than traditional testing, including Pap and human papilloma virus (HPV). Results of the studies were presented at the biennial meeting of the American Society of Colposcopy and Cervical Pathology in Las Vegas.
One study, conducted at the University of Texas Southwestern Medical Center (Dallas), compared the results of a Pap test to the SpectRx tests and HPV test. Results were reported for 102 women who underwent biopsy. The sensitivity – the ability to accurately detect cancer – of both tests was 95%. The specificity, the ability to accurately detect benign or health tissue, was 65.5% for the Pap/SpectRx test vs. 27.4% for the Pap/HPV test.