HPV Testing Technology

• By mickietucs
• Posted October 28, 2009 at 11:01 pm
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Corellin - very interesting and yes, I wonder how long it'll be until (well IF) it's used in the states. I've also read some company (can't recall now) is developing some kind of "scanner" that may eventually be used instead of having to have a biopsy to detect dysplasia. Wish I had saved that info/link. All of these new procedures would be of benefit. Let's hope it's sooner rather than later. Thanks for sharing.

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• By corellin
• Posted October 29, 2009 at 1:09 am
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Hi mickietucs -- I remember reading an article about the scanner also -- a year or two ago. I wish I had a better system for keeping track of things. I've lost so many articles I wish I could find. How about a scanner for HPV testing -- something that would go over a penis like a geiger counter?

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• By flowershoplady
• Posted October 29, 2009 at 10:09 am
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LOL! Love the image of a scanner type wand being waved over a penis like a geiger counter. :) And, of course, it's something we each have at home!

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• By mickietucs
• Posted October 29, 2009 at 10:17 am
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I get this image like on CSI - someone w/the glasses, light and scanner and whatever lesions are on there show up under the "special light"/scanner!!

Actually to be serious for a moment I just read one of "our" docs (at the university where I work) got a small grant to do a study on technology that would send a digital image to the pathologist --- no more needs for slides being used - here's an excerpt:

Ana Maria Lopez, MD, MPH - Assessment of Clinical Efficacy Utilizing Telepathology for Paps.

This study aims to use technology to improve the ability to detect premalignant cells, in the hope that cervical cancer may be prevented. Though cervical cancer is treatable - and when detected early, is curable - detection of premalignant disease is the most clinically-effective and cost-effective outcome. This study will assess the role and accuracy of telepathology - using telecommunication technology to transmit a digital image to a pathologist - in cervical cancer screening. By eliminating the need for glass slides, breakage and loss of clinical material would not be a concern. Further, as a digital image, the clinical material may be easily and rapidly transmitted electronically for primary or second-opinion reads, which may be of greatest benefit to women in underserved, rural or remote areas and in developing countries. Finally, the digitized images allow for the addition of annotations, which may facilitate communication between consultants and may be helpful with education.

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• By corellin
• Posted October 29, 2009 at 10:30 am
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Mickietucs -- Sounds interesting! I first read it as using "telepathy." I guess there's a big difference between telepathy and telepathology.

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• By mickietucs
• Posted October 29, 2009 at 10:45 am
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Found it! This was just this year so wonder if it'll ever "happen." This would be great - no more biopsies!

Friday, February 13, 2009

LightTouch Device May Eliminate Pap, Biopsy for Cervical CA Testing

Filed under: Ob/Gyn , Oncology

A new light based test that detects early signs of cervical cancer may be a better diagnostic tool than a pap smear, according to preliminary findings from a multi-site Food and Drug Administration (FDA) pivotal clinical trial. The study of more than 1,900 women looked at Guided Therapeutics' LightTouch system, a device that uses optical probe to shine light at different wavelengths and to detect alterations in fluorescence spectra coming back from the dysplastic /cancerous growth.

From the press release:

Since the pivotal trial began, more than 1,900 women were tested to demonstrate the technology’s safety and efficacy in detecting cervical disease, including an arm of the study that assessed effectiveness of an investigational commercial version of the device and single-use disposable.

The study protocol indicated that all subjects were referred after undergoing a Pap test, or had some other risk factor that fulfilled the referral criteria of the study. Each subject was tested with the LightTouch investigational device and underwent an additional Pap test, colposcopic exam and biopsy. Two generations of the investigational LightTouch were used in the trial.

Preliminary results from the study showed that the LightTouch performed better than the Pap test. The investigational commercial version of the LightTouch detected approximately 46 percent more cervical disease than the Pap test – a statistically significant improvement.

Here's more about the technology from the manufacturer:

The device system (Guided Therapeutics, Inc. Norcross, GA, USA) used in the study is a nonsignificant risk device by FDA standards that noninvasively and automatically scans the ectocervix and distal endocervix for disease related changes in fluorescence and reflectance spectra.

Alterations in fluorescence spectra are indicative of metabolic changes associated with neoplasia, while alterations in reflectance and scattering are indicative of structural changes associated with neoplasia, such as epithelial thickening, nuclear size, nuclear content and angiogenesis.

A plurality of equally spaced points over a one-inch diameter area of the cervix was automatically scanned during a four-minute period using a filtered xenon arc lamp as an illumination source.

For cervical tissue reflectance measurements, broadband spectral output ranging from about 350 to 900nm was automatically applied under software control to the cervix using the same xenon arc lamp. The resultant reflectance spectral output from the cervical tissue was imaged onto the CCD camera and stored for processing and analysis.

For cervical tissue fluorescence measurements, light from the arc lamp was band pass filtered to limit exposure of the cervix to bands within the 300 to 500 nm range. These spectral bands are known to excite fluorophores associated with neoplastic processes as described above. Each of the fluorescence wavelengths were applied automatically under software control in a predetermined order and scan pattern. The resultant fluorescent spectral output of the cervical tissue was imaged onto a charge coupled device (CCD) camera and stored for processing and analysis.

The system consists of two main physical components, the hand-held unit and the base unit. The handheld unit is connected to the base unit via fiberoptic cables for transmission of light to and from the base unit, which contains the xenon arc lamp, optical processing elements (e.g., filters and lenses) and the CCD camera on a rolling cart (CNDS Device).

The other major component of the CNDS is a computer for control and data processing. This includes the capability for a diagnostic algorithm based on spectroscopic information measured from the cervix, calibration data and other patient data, such as Pap results or patient demographic data.

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• By mickietucs
• Posted October 29, 2009 at 10:51 am
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Just released this month --- you can Google "Guided Therrapeutics LightTouch" and find out more (wonder how expensive this would be - probably a lot at the beginning but maybe come down as more and more docs use it) ----

National Cancer Institute Grants Guided Therapeutics, Inc. $2.5 Million to
Commercialize Noninvasive
Cervical Cancer Detection Device
Funds to help commercialize painless test, with immediate results, for cervical disease
NORCROSS, GA (October 5, 2009) – Guided Therapeutics, Inc. (GT) (Pink Sheets:
GTHP) today announced that it was awarded a $2.5 million matching grant by the National
Cancer Institute (NCI) to bring to market and expand the array features for its LightTouch™
noninvasive cervical cancer detection technology.

The award provides resources to complete the
regulatory process and begin manufacturing ramp up for the device and singlepatientuse
disposable.

“This grant provides significant nondilutive
resources for us to begin manufacturing
LightTouch devices and disposables for an international launch, as we simultaneously complete
the U.S. Food and Drug Administration (FDA) premarket approval (PMA) application process,”
said Mark L. Faupel, Ph.D., President and CEO of GT.
Including the new award, the company has been awarded approximately $6 million in six
consecutive grants from the NCI to develop the new, painfree test for detecting cervical disease.

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