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... The WavSTAT OPTICAL BIOPSY SYSTEM developed by SpectraSCIENCE is capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body and without waiting days for a pathology report. The WavSTAT™ OPTICAL BIOPSY SYSTEM uses a spectrophotometry technique known as Laser Induced Fluorescence (LIF). During LIF cool laser light shines onto and excites body tissues to emit a returning fluorescent signal. The emitted fluorescence is collected, measured and analyzed by a computer. A proprietary statistical tissue recognition algorithm provides the physician with an immediate analysis of the tissue. SpectraSCIENCE received US Food and Drug Administration (FDA) clearance to market the WavSTAT™ system as an adjunctive tool for small polyp evaluation during endoscopic colorectal cancer screening procedures in November 2000. The product also has the CE mark, a prerequisite for sales in the European Union.

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Luma
Introducing the Luma CERVICAL IMAGING SYSTEM
The LUMA® Cervical Imaging System was developed to significantly improve the detection of high-grade precancerous cervical abnormalities that have the potential of becoming invasive cancer. Based on data from the ALTS study, it is estimated that about 200,000 women with precancerous disease go undiagnosed each year.

LUMA provides a safe and effective method, that when used as an adjunct to colposcopy, will find at least 25% more high-grade precancerous disease than the gold standard colposcopy in women with ASC and LSIL Pap tests.


Introducing the WavSTAT OPTICAL BIOPSY SYSTEM

WavSTAT Model 3 Console
Optical Biopsy System probe head

... The WavSTAT™ OPTICAL BIOPSY SYSTEM console (see the picture to the right) contains a laser, electronic components that collect the emitted fluorescent signals, and a computer that operates the system and analyzes the tissue. The WavSTAT™ Optical Biopsy Forceps with an incorporated optical fiber (see the picture to the left) delivers the laser light when in contact with the tissue. The forceps with fiber also returns the emitted fluorescent signal to the console for analysis. The WavSTAT™ Optical Biopsy Forceps are used through the working channel of a standard endoscope and can also be used to begin immediate treatment of the patient by removing diseased tissue after a tissue's analysis has been made.

Early Cancer Detection is the Key

...According to the American Cancer Society, approximately 145,000 new cases of colorectal cancer are diagnosed annually in the United States. With an estimated 56,000 deaths in 2005, colorectal cancer is second only to lung cancer as the leading cause of cancer death. Colorectal cancer affects men and women equally, and in fact more women over the age of 75 will die from colorectal cancer than from breast cancer.

...Using current methods and techniques to detect and treat colorectal cancer, the American Cancer Society reports these outcomes:

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 The five-year survival rate is 92% if detected and treated at an early stage;
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 The five-year survival rate drops to 64% if the cancer spreads outside the colon to the lymph nodes;
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 The five-year survival rate for those patients in whom the cancer has spread further to the liver or other organs drops dramatically to 7%.

...It is clear from these outcomes that early detection is essential to long-term survival. Unfortunately, it is also reported by the American Cancer society that only 37% of colorectal cancer is currently found at an early stage. Our goal at SpectraSCIENCE is to develop technology and products that demonstrably improve cancer detection. The WavSTAT™ OPTICAL BIOPSY SYSTEM is another diagnostic tool that makes early detection possible which may mean earlier treatment and improved patient outcomes.

 

OPTICAL BIOPSY SYSTEM - Clinical Use
...During a screening endoscopic examination for colorectal cancer, an optical biopsy is obtained by contacting tissue with the tip of the WavSTAT™ Optical Biopsy Forceps. Short-duration pulses of cool laser light are transmitted through the optical fiber within the forceps. The tissue absorbs the laser light and fluoresces. The fiber returns the fluorescence signals to the console and the spectra of the patient's tissues are analyzed and results are displayed on the console. WavSTAT's technology measures the tissue's native fluorescence, without pretreatment with dyes, contrast or photosensitive drugs.

Chart showing normal and suspect spectrum

NOT SUSPECT Icon
SUSPECT Icon

...The graph to the left compares the spectral data from hyperplastic and adenomatous polyps. A hyperplastic polyp, defined as one that is normal or benign, is represented by the green curve. An adenomatous polyp that is considered to be pre-cancerous is represented by the red curve. By comparing the received spectral information to the spectra of adenomatous and hyperplastic tissue, the system determines whether the tissue is "suspicious" (adenomatous) or "not suspicious" (hyperplastic). Within one second, tissue evaluation is displayed on the console as either a green "not suspect" icon or a red "suspect" icon.

load and play movie

...Click the Demo button to see how the WavSTAT™ Optical Biopsy Forceps is used to contact a small polyp. Pulses of cool laser light move down the opened forceps and excite the polyp tissue. The tissue fluoresces and reflects light back to the console. In this demonstration, the first polyp that is optically biopsied is normal or non-cancerous. This is represented by the return of green light bursts through the opened forceps and back to the console. The second polyp that is optically biopsied has been determined to be pre-cancerous tissue. This is represented by the return of red light bursts through the opened forceps and back to the console. The Optical Biopsy Forceps is then used to remove the small polyp that has been evaluated as "suspect."

... The WavSTAT™ OPTICAL BIOPSY SYSTEM was specifically designed to be used during screening endoscopy of the colon to aid and improve the physician's ability to identify small polyps as normal, pre-cancerous or cancerous tissue. Results from the Company's FDA regulated clinical studies performed at the Mayo Clinic (Rochester, MN), Massachusetts General Hospital (Boston, MA), Hennepin County Medical Center (Minneapolis, MN) and Minnesota Gastroenterology P.A. (St. Paul and Minneapolis, MN) demonstrated that using the WavSTAT™ OPTICAL BIOPSY SYSTEM during colorectal endoscopic screening significantly increased the physician's diagnostic accuracy to detect a pre-cancer or cancer from 82% to 96%.

Indications for Use
...The SpectraSCIENCE WavSTAT™ OPTICAL BIOPSY SYSTEM is intended to be used as an adjunct to lower gastrointestinal endoscopy. The device is intended for the evaluation of polyps less than 1 cm in diameter that the physician has not already elected to remove. The device is only to be used in deciding whether such polyps should be removed (which includes submission for histological examination).

Contraindications
...The use of this device is contraindicated in patients who have pre-existing abnormalities of the coagulation system which contraindicate endoscopic biopsy and/or polypectomy, other conditions that prevent endoscopic biopsy or removal of colonic polyps, or familial polyposis.

... If you would like a brochure on the WavSTAT™ OPTICAL BIOPSY SYSTEM, click here for a printable PDF copy (requires Adobe™ Acrobat Reader™). You can also receive product information from our Sales & Marketing department.

LASER-INDUCED FLUORESCENCE SPECTROSCOPY

... The WavSTAT™ OPTICAL BIOPSY SYSTEM is based upon technology that detects the native fluorescence of tissue. Fluorescence occurs when various molecular components present in human tissue are excited at certain wavelengths of light and re-emit energy in a distinct and measurable way, which is referred to as the spectral signature. Healthy tissue generates a spectral signature that is measurably different from tissue that is not normal, such as cancerous and pre-cancerous tissue.