National Cancer Institute Grants Guided Therapeutics, Inc. $2.5 Million To Commercialize Non-Invasive Cervical Cancer Detection Device

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Cancer / Oncology
Article Date: 07 Oct 2009 - 2:00 PDT

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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™ non-invasive cervical cancer detection technology. The award provides resources to complete the regulatory process and begin manufacturing ramp up for the device and single-patient-use disposable.

"This grant provides significant non-dilutive 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) pre-market 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, pain-free test for detecting cervical disease.

"We believe that the grant validates the development of our cost effective cancer detection technology, as the NCI reviewed a combination of our technical approach, commercialization plan and clinical performance to date in making the award," said Shabbir Bambot, Ph.D., Vice-president of Research and Development for GT and principal investigator of the grant. "Additionally, we believe that our scientific approach and underlying intellectual property position were key factors in being awarded this grant."

The GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively, by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue, by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately. The technology is designed as a device employing a single-use disposable patient interface.

Since development of the technology began, more than 3,000 women have been tested with the LightTouch, including more than 1,900 women who were evaluated as part of the FDA pivotal clinical trial.

According to studies published in the peer-reviewed Journal of Lower Genital Tract Disease, the non-invasive LightTouch test has the potential to be significantly more accurate when compared to tissue sample-based tests such as the Pap smear.

Source
Guided Therapeutics