News | February 25, 2009

New Identafi 3000 Identifies Signs Of Silent Killer

Houston, TX - What the oral cancer detection market needs is a breakthrough medical device that is affordable and easy to use and, most important, immediately and reliably detects pre-cancer or cancer in the oral cavity.

Next-Generation Technology Introduced by Trimira

Houston-based Trimira LLC is now rolling out a next-generation oral cancer-screening device that will change the diagnostic landscape for doctors and dentists. Called Identafi 3000, the new device consists of a "multispectral" optical illumination and visualization system housed in a small cordless handheld unit specifically designed for use by dentists, periodontists, oral surgeons, otolaryngologists, and primary-care physicians.

"As they work to accurately and immediately screen for both pre-cancer and cancer, the medical community has a crying need for technology that not only will reliably deliver enhanced specificity, sensitivity, and efficacy, but is inexpensive enough that every doctor and dentist's office can carry it," Trimira VP Jerry S. Trzeciak said.

Unlike other methods, Trimira's Identafi™ 3000 enables doctors and dentists to locate biochemical and morphological changes in the cells of the mouth, throat, tongue, and tonsils, and to get real-time results.

"Oral cancer kills one person every hour of every day," Trzeciak said. "The way to stop it is through early detection, and that means getting every doctor and every dentist involved in that effort."

Having received FDA approval in recent months, Identafi™ 3000 will be unveiled at the 144th Midwinter Meeting of the Chicago Dental Society to be held at McCormick Place in Chicago Thursday, Feb. 26 to Sunday, Mar. 1.

Filling the Early-Detection Technology Vacuum

Identafi 3000 enables those on the front line of detection to catch early signs and stages of oral cancer and pre-cancer that are often missed by the naked eye — which is currently the 'default' means of early detection.

"Trimira's multispectral Identafi technology platform allowed for development of a device that combines three separate wavelengths to visualize both fluorescence and reflectance images in the oral cavity," Trzeciak said. "Trimira's oral cancer screening device can spot the location of pre-cancerous cells and determine the extent of the disease in the area being screened."

Trimira's Identafi technology includes multiple patents and seven patents pending that relate to the detection of pre-cancerous conditions (dysplasia) and cancers. Detection occurs through the processing of optical fluorescence and reflectance in body tissues. The core technologies are based on high-speed, high-resolution, multispectral capabilities from its optical processing technology. The device is able to read metabolic differences in diseased and healthy tissue.

Trimira will leverage the Identafi technology platform to develop diagnostic products that will be able to detect pre-cancerous cells and cancers in other body tissues, including, but not limited to, the cervix, bladder, esophagus, and colon.

$30 Million and 15 Years of Research

The research team that developed the breakthrough multispectral optical illumination system includes:

  • Dr. Michele Follen, The University of Texas' M.D. Anderson Cancer Center;
  • Dr. Rebecca Richards-Kortum, Rice University
  • Dr. Calum Macaulay, British Columbia Cancer Research

The technology was developed by research scientists at The University of Texas' M.D. Anderson Cancer Center and British Columbia Cancer Research Centre.

Trzeciak noted that the research effort has cost some $40 million over 15 years.

Identafi 3000 uses white, violet, and amber wavelengths of light to excite oral tissue in distinct and unique ways. Biochemical changes can be monitored with fluorescence, while morphological changes can be monitored with reflectance. The combined system of fluorescence and reflectance uses the body's natural tissue properties as an adjunctive tool for oral mucosal examination. Conventional examination of tissue is performed using a highly concentrated white light.

A health professional wears reusable Identafi 3000 filtered eyewear to enhance visual effects and allow transmission of reflected light, then switches to violet for a second observation. The clinician's filtered glasses block the violet excitation light and allow the observance of the tissues natural fluorescence. Violet light enhances normal tissue's natural fluorescence; however, suspicious tissue appears dark because of its loss of fluorescence.

When suspect abnormalities are present the selector is switched to amber light, which enhances normal tissue's reflectance properties so the clinician may directly observe the difference between the normal and abnormal tissue's vasculature. This minimizes the impact of confounders when screening and diagnosing oral cancer.

Studies indicate abnormal tissue has a diffuse vasculature, while normal tissue vasculature is clearly defined. The combination of all three multispectral wavelengths provides the clinician with more visual information to differentiate between areas of normal and diseased tissue, and improve decision-making for the health professional in recommending biopsies. In delivering a new "highest standard of care" for patients, Identafi™ 3000 does away with the use of messy and bad-tasting dyes and solutions while ensuring a more thorough oral examination.

Accuracy Is Key to Lowering Oral Cancer Rates

Trzeciak noted that oral cancer has become epidemic due to the lack of effective, broad-based early detection programs. In fact, the oral cancer death rate now surpasses that from breast, cervical, or prostate cancers. The rise in oral cancer has occurred despite decreased use of tobacco products. The reason is thought to be the disease's link to the HPV 16 and 18 viruses.

One of the most common virus groups in the world, HPV (human papilloma virus) affects the skin and mucosal areas of the body. More than 100 types of HPV have been identified.

Oral cancer is often detected late in its development, when the possibility of metastasis is far greater. Like most cancers, cancer of the lip and oral cavity are best treated when found early.

Trzeciak added: "This new technology is huge, and has the potential to transform the landscape of early detection."