Medical Device Daily

SpectRx (Norcross, Georgia) has reported that it has built and successfully tested its first pre-production, non-invasive cervical cancer detection device, a device that, if approved, could immediately shift a market long-dependent on Pap testing.

The device, which was developed in part by SpectRx, identifies cancers non-invasively by analyzing light reflected from the cervix. The instrument contains "major components" planned for use in commercial production and will be used to complete the ongoing FDA pivotal clinical trial necessary for regulatory approval.

Begun in March 2004, the pivotal trial has used an "alpha" prototype device.

"Completion of this beta device, and single-patient-use disposables, is a major milestone in the process of bringing this unique technology to market," said Mark Faupel, president and chief operating officer of Guided Therapeutics, a company spun off from SpectRx to commercialize its cervical cancer detection device, in a statement.

"We are pleased with the initial technical performance of the pre-production device and single-use disposable, both of which will benefit from advances in our patented technology and component optimization. Additionally, we believe that this new-generation system will enable us to reach our price-of-production goals, thus making the technology affordable to the general ob/gyn and family practice physician," he said.

Faupel also said that Guided Therapeutics expects to place the first new device in the pivotal clinical trial early this year.

"These new devices will allow us to close out the human data collection phase of the FDA trial and begin preparation of the important clinical data section of the premarket approval," Faupel said.

Bill Wells, director of communications for SpectRx, told Medical Device Daily that "during a typical vaginal exam" the device is inserted into the speculum which is typically used in the exam, and a broad-spectrum white light is focused on the cervix. The light that is bounced back into the device reflects into a spectrometer before being broken down into its "constituent wave lengths and ... measured."

Similar to "the way NASA looks at stars and planets and can tell you if it has hydrogen and all these different things," Wells said, the SpectRx device "uses spectroscopy to look at the return light. Basically the device knows what 'normal' should look like, and if there are variations in the light coming back, different from the normal, it indicates that there's an abnormality there in the reflected light."

Wells said that "certain chemicals" present in precancerous and cancerous cells, and these produce the reflections that serve as the markers for cervical cancer.

"It changes something called scattering, or changing the pattern of light," he said.

Wells also said that the device is used much like today's culpascope, and that the "whole idea behind the instrument is that the sophistication would be built into the device."

SpectRx said that unlike the Pap or tests of the human papillomavirus, the test does not require a tissue sample or laboratory analysis, and results are available immediately by reading the light that is reflected.

This non-invasive strategy has been seen by this sector as extremely important for expanding testing in this area, especially in those countries culturally resistant to the protocol of Pap testing.

To date, the company reported that more than 1,600 women tested with prototypes of the device.

The company hopes to complete the pivotal clinical trial sometime this year after meeting certain demographic targets, and a report would be filed with the data to the FDA. Depending on when Guided Therapeutics receives additional funding, Wells said a premarket approval application to the FDA would follow.

The company has not disclosed the amount of the funding it is seeking for the spinoff, Guided Therapeutics, only that it would be "separately funded."

The company in February 2003 received a $1.4 million grant award from the National Cancer Institute (NCI; Bethesda, Maryland) to support the development of its detection device. The grant is being used primarily to fund the clinical trials, the company said. At the time, Faupel called the grant "a significant endorsement of our technology."(MDD, Feb. 24, 2003).

Last February, SpectRx reported that it was partnering with Emory University (Atlanta) as part of a $64,700 grant to Emory from the Georgia Research Alliance (Atlanta) to support the clinical trials (MDD, Feb. 16, 2005). It was to be used to study the cervical cancer detection device at Grady Memorial Hospital (also Atlanta) under the guidance of Lisa Flowers, MD.

Also attempting to bring a spectroscopic-based device to market, the Luma Cervical Imaging Device, is MediSpectra (Lexington, Massachusetts), but Wells said the FDA did not approve the device.

And Grant Life Sciences (Salt Lake City) is developing what it terms "a simple blood test" for the detection of cervical cancer.

SpectRx cites published reports estimating cervical cancer as the third most common cancer among women worldwide. Globally, there are about 471,000 cases of cervical cancer diagnosed annually and about 233,000 deaths each year.

Extrapolating from the total of 60 million Pap tests performed annually in the U.S., the company estimates the annual global market potential for a non-invasive cervical cancer test to be more than $1.3 billion.