GT answers FDA questions for LuViva PMA application
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).
This important trade magazine magazine covers Guided Therapeutics’ FDA progress with its cervical cancer screening device.