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Guided Therapeutics

Georgia-based Guided Therapeutics has developed LuViva, a non-invasive medical device designed to instantly detect cervical disease in a point-of-care setting. They have successfully moved from concept to prototype to product with awards from the NCI SBIR program, including a $2.5 M Bridge Award in 2009.

According to Guided Therapeutics Vice President of Product Development and Principal Investigator Shabbir Bambot, Ph.D., "Funding received through the SBIR Bridge program was especially critical because it reduced our risk and incentivized investors to contribute an additional $5.5 million. This financial stimulus served as a springboard to facilitate commercialization of the technology, form strategic partnerships, and attract talented professionals."

The LuViva device has been tested on about 3,000 women at 10 clinical centers in the US with positive results. These are currently under FDA review as part of a premarket approval (PMA) application as a test for cervical disease following initial screening. LuViva could potentially replace a sizable portion of colposcopic biopsies performed to rule out cervical cancer.

To prepare for LuViva's commercial launch, Guided Therapeutics has added staff, growing from 15 to 40 full-time employees since 2008. Over the same time period, the company has increased market capitalization from under $10 million to approximately $45 million, and increased revenues from under $1 million to over $4 million. LuViva also shows potential for global impact, as potential international clients are already placing orders for demonstration devices.

The company recently announced an Asian regional partnership with Konica Minolta Opto for distribution and screening clinical trials of LuViva Advanced Cervical Scan. Also in collaboration with Konica Minolta Opto, Guided Therapeutics' biophotonics technology platform is currently undergoing human feasibility studies to detect Barrett's Esophagus, a precursor for esophageal cancer.

Guided is currently working on a planned, future application for LuViva in early detection of cervical intraepithelial neoplasia (CIN) that retains high true positive predictive rates while reducing false positives. This figure compares a (top) normal colposcopy image and corresponding color map showing lack of disease ("cool" colors) with a (bottom) colposcopy image showing cervical dysplasia (CIN 3) and corresponding color map based on spectroscopy results that correctly identifies both the CIN ("hot" colors) and normal tissue.

About the NCI-Supported Technology

Guided Therapeutics' patented biophotonic technology, Hyperspectral Imaging Spectroscopy (HIS), uses light to detect physical and biochemical changes in tissue. Multiple wavelengths of light are directed at the tissue. The light gets reflected back and can then be analyzed using a spectrometer. Since normal cells and cancerous cells reflect light in different ways, HIS can identify the different types of cells from their unique spectral signatures.

The LuViva cervical scan device using HIS technology consists of a base unit and a single-patient-use disposable probe. The device painlessly and non-invasively scans the cervix with light to identify cancerous and pre-cancerous cells. Light reflected from the cervix is analyzed by a spectrometer. Information from the spectrometer is then used to generate an image of the cervix that distinguishes healthy tissue from diseased tissue. Seventeen patents have been granted during development of this technology.

Advancing Cancer Research

The LuViva cervical scan is a groundbreaking, innovative technology that facilitates non-invasive early cancer detection. The diagnostic platform offers significant advantages compared to current standard detection methods such as Pap smears, HPV (human papillomavirus) tests, and colposcopic biopsy. It is designed to provide immediate results, as it does not require laboratory analysis or a tissue sample. It is easy to operate and the scan can be performed by a nurse practitioner or physician's assistant with minimal additional training.

LuViva may even be a superior screening modality for noninvasive cervical cancer. In studies to date, for patients with moderate dysplasia, it detects cervical cancer with a sensitivity of greater than 90% compared with 76% sensitivity for the current standard of care methods. In a two-year follow-up of 804 subjects, results from a pivotal clinical trial demonstrated that the technology has a high negative predictive value and could reduce the number of unnecessary biopsies by nearly 40% in women with no disease and 30% for women with low grade dysplasia, while detecting disease up to 2 years earlier than with Pap smears, HPV test, and biopsies.

Pending FDA approval, the test is designed to be primarily marketed as a technology to effectively rule out cervical cancer, reducing the need for invasive confirmatory procedures such as colposcopic biopsy. Additionally, as it is more economical than colposcopic biopsy, it may provide significant cost savings for patients and the healthcare system. In the pivotal clinical trial, LuViva showed it detected disease that was missed by the standard of care in addition to reducing unnecessary confirmatory tests.

The market potential for LuViva is immense. According to the American Cancer Society, after decades of decline, cervical cancer rates in the US have risen by 26% in the past 5 years. Therefore, developing clinically-relevant, non-invasive and efficient screening tests for early cancer detection is a high priority. In developing nations such as India, where rates of cervical cancer are much higher and standardized cytology and pathologic analysis is not widely available, LuViva offers a non-invasive, cost-effective, and accurate alternative with the availability of immediate results.

Guided Therapeutics' patented biophotonic technology has been developed into a non-invasive screening tool for pre-invasive cervical cancer. The innovative platform has the potential to revolutionize the field of oncology diagnostics with the possibility for broader application towards screening of other pre-invasive cancers.

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Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Cancer Institute (NCI), the NCI's Small Business Innovation Research (SBIR) & Small Business Technology Transfer (STTR) Programs, or any other portion of the U.S. Government.