Scientists Use Spectroscopy to Study Black Holes, Stars, and Now Cervixes

Scientists Use Spectroscopy to Study Black Holes, Stars, and Now Cervixes

Scientists use spectroscopy to examine the make-up of celestial objects. Now, they’re taking the technology in a decidedly different direction and using it to detect cervical cancer.

Over the past decade, Guided Therapeutics has identified cellular markers specific to cervical cancer cells, which their new device identifies by shining a spectrum of light on the tissue. Like spectroscopy for planets and stars, the company’s LuViva Advanced Cervical Scan shines light on the object of interest, then analyzes how that light is reflected. The technique is non-invasive and doesn’t require tissue samples or lab tests, which is reason to celebrate for anyone who’s had a Pap-smear or cervical biopsy.

“Every molecule has a spectral fingerprint. If you hit it with a specific wavelength of light any tissue will reveal its nature and tell you something about itself,” Mark Faupel, CEO of Guided Therapeutics, told me during a phone interview. “We’ve adapted this technology used by NASA to identify whether there’s life on other planets to detect cancer cells in tissue in vivo (i.e. in a live person).”

In studies looking at 1,600 cervixes, the company’s scientists found that the device detected 90 percent of cervical cancers an average of two years earlier than Pap smears, the technique currently used by doctors for early diagnosis. Pap smears are a good way to detect cervical cancer early but they also lead to a lot of false positives—only 20 percent of patients who have abnormal Paps actually require treatment. That’s an 80 percent false positive rate. The test also completely misses two-thirds of pre-cancerous cells.

False positive or not, an abnormal Pap smear typically leads to a colposcopy, which is basically a quick but sometimes painful scrape of the cervix’s surface cells to obtain a biopsy.

Cervical cancer, which is usually caused by human papilloma virus, is a major killer of women, especially in developing countries where women have less access to Pap smears. In the United States where Pap smears are routine, most women catch pre-cancerous cells early enough that it’s 100 percent treatable by removing the abnormal cells with cryosurgery or laser therapy. But in places where Pap tests are not routine and cervical cancer often goes undetected until it has spread, LuViva could save lives. The device will be relatively inexpensive at about $20,000, so Faupel hopes smaller clinics will be able to afford one.

“We wanted to make it accessible to use on a reservation for Native Americans or rural clinics in developing countries,” he says. “This can be used for the underserved population, not just afforded by large industrial hospital complexes.”

The National Cancer Institute has granted Guided Therapeutics $6 million to develop the technology, and the company hopes to receive final FDA approval to market the device sometime this month.

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Scientists Use Spectroscopy to Study Black Holes, Stars, and Now Cervixes

Scientists use spectroscopy to examine the make-up of celestial objects. Now, they’re taking the technology in a decidedly different direction and using it to detect cervical cancer.

Over the past decade, Guided Therapeutics has identified cellular markers specific to cervical cancer cells, which their new device identifies by shining a spectrum of light on the tissue. Like spectroscopy for planets and stars, the company’s LuViva Advanced Cervical Scan shines light on the object of interest, then analyzes how that light is reflected. The technique is non-invasive and doesn’t require tissue samples or lab tests, which is reason to celebrate for anyone who’s had a Pap-smear or cervical biopsy.

“Every molecule has a spectral fingerprint. If you hit it with a specific wavelength of light any tissue will reveal its nature and tell you something about itself,” Mark Faupel, CEO of Guided Therapeutics, told me during a phone interview. “We’ve adapted this technology used by NASA to identify whether there’s life on other planets to detect cancer cells in tissue in vivo (i.e. in a live person).”

In studies looking at 1,600 cervixes, the company’s scientists found that the device detected 90 percent of cervical cancers an average of two years earlier than Pap smears, the technique currently used by doctors for early diagnosis. Pap smears are a good way to detect cervical cancer early but they also lead to a lot of false positives—only 20 percent of patients who have abnormal Paps actually require treatment. That’s an 80 percent false positive rate. The test also completely misses two-thirds of pre-cancerous cells.

False positive or not, an abnormal Pap smear typically leads to a colposcopy, which is basically a quick but sometimes painful scrape of the cervix’s surface cells to obtain a biopsy.

Cervical cancer, which is usually caused by human papilloma virus, is a major killer of women, especially in developing countries where women have less access to Pap smears. In the United States where Pap smears are routine, most women catch pre-cancerous cells early enough that it’s 100 percent treatable by removing the abnormal cells with cryosurgery or laser therapy. But in places where Pap tests are not routine and cervical cancer often goes undetected until it has spread, LuViva could save lives. The device will be relatively inexpensive at about $20,000, so Faupel hopes smaller clinics will be able to afford one.

“We wanted to make it accessible to use on a reservation for Native Americans or rural clinics in developing countries,” he says. “This can be used for the underserved population, not just afforded by large industrial hospital complexes.”

The National Cancer Institute has granted Guided Therapeutics $6 million to develop the technology, and the company hopes to receive final FDA approval to market the device sometime this month.

GT answers FDA questions for LuViva PMA application

GT answers FDA questions for LuViva PMA application

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=76690

By AMANDA PEDERSEN

September 6, 2011

Medical Device Daily Senior Staff Writer

Guided Therapeutics (Norcross, Georgia), a developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, says it has answered all of FDA’s key questions regarding the company’s premarket approval (PMA) application for the LuViva Advanced Cervical Scan.

“We are pleased to provide the FDA with the additional information the agency requested and within the time period required to maintain the PMA application under active review,” said Mark Faupel, PhD, president/CEO of Guided Therapeutics. “The FDA will review our submission, we hope move forward with the PMA process and schedule a panel meeting date, although the agency has the option to ask for additional information.”

LuViva scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively, the company noted. Guided Therapeutics’ biophotonic technology is designed to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, LuViva does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly and painful unnecessary testing, the company said.

Faupel told Medical Device Daily that the sequence of events with FDA so far has followed a “normal” track. “There are a number of people at FDA involved in formulating questions both with regard to the clinical side of the clinical trial and technical side of the instrumentation,” he said. There were several questions the company had previously dealt with by submitting draft responses and the majority of those were accepted on what Faupel referred to as a “first round.” There was one question, however, that the agency asked for additional information on which Guided Therapeutics says has now been dealt with. He declined to say what that issue was for competitive reasons. Now the company just has to wait and see if and when a panel meeting is scheduled.

“It was a necessary and major step in getting us closer to that panel meeting,” Faupel said.

The company submitted its PMA application about a year ago (Medical Device Daily, Sept. 28, 2010). In its pivotal trial, more than 1,600 women at risk for cervical disease were tested with the device. According to the company, the device detected cervical disease up to two years sooner than a Pap test, HPV test, colposcopy or biopsy and it detected 86.3% of cervical disease cases that had been missed by these other methods. Also, the device would have reduced the number of unnecessary biopsies by about 40%.
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The fact that the questioning phase of the process was so involved simply reflects that the company has a “fairly high visibility product with a lot of reviewers” involved, Faupel said. “They are more involved in the questions . . . leadership at FDA is very conscious now of the issues that have occurred in the past.”

While it waits for a panel meeting to be scheduled, Guided Therapeutics continues to make progress with its planned international launch and have orders in place with distributors for demonstration and clinical units for Europe and Asia, Faupel said.

“This is a product that we feel strongly will have a home not just in the U.S.,” Faupel told MDD. “It was designed to be low cost, easy to use, easy to train the user, [and] easy to interpret the results.”

Such features are what sets the technology apart from existing testing methods, he said.

“The current standard of care involves a lot of human interaction and data,” he said. He added that an initial PAP test, which requires a highly trained technician to interpret and that another test involving a magnified view of the cervix requires a well-trained physician to interpret and is subjective. “They all involve a lab delay to get a final answer, where as with our product you get a final answer at the point of care.”

The company was recently awarded $517,000 to fund the third year of a $2.5 million three-year grant from the National Cancer Institute (NCI). The grant provides additional resources to help commercialize and bring the LuViva to market. The company has been awarded more than $6 million in six consecutive grants from the NCI to develop the new test for detecting cervical disease since 2001 (MDD, Aug. 26, 2011).

In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports.

The company has also entered into a partnership with Konica Minolta Opto (Tokyo) to develop a non-invasive test for Barrett’s esophagus using the technology platform.

“This is a platform technology and we believe it can be utilized to detect nearly 90% of all cancers in the body,” Faupel said.

In fact, the company has already begun human testing of its light-based technology for Barrett’s Esophagus, a precursor for esophageal cancer. The feasibility study is designed to test the concept of using the platform for the detection of changes in esophageal tissue. The study also tests various hardware and procedural configurations and is designed to determine a way forward for product development and further clinical trials. The feasibility study is expected to enroll about 40 subjects and be completed before the end of the year. It is being conducted at two Atlanta-area clinics (MDD, Aug. 11, 2011).