Technology
How it applies to our products
Product Research and Development
The core LIF technology of the WAVSTAT Optical Biopsy System serves as a platform from which tissue evaluation applications for visually undetectable cellular abnormalities and cancer detection can be created. SpectraScience is currently developing a second application to evaluate patients undergoing esophageal endoscopy for pre-cancerous tissue changes that may lead to esophageal cancer. SpectraScience also sees significant opportunities to develop applications for distinguishing tissue changes that lead to other cancers including lung, skin and oral cancer.
Esophageal Cancer
The next application chosen for the WavSTAT Optical Biopsy System is for the detection of pre-cancerous and cancerous tissue in the esophagus. The progression toward esophageal cancer begins with several pre-cancerous stages. It is critical for the physician to be able to identify these various stages of the disease in order to deliver the most appropriate treatment. As with colorectal cancer, early and accurate detection results in less invasive, more cost effective treatments with a greater chance for long term patient survival. Esophageal cancer is growing six times faster than other cancers.
Barrett's esophagus is a condition of the lining of the lower esophagus thought to be caused primarily by Gastro Esophageal Reflux Disease (GERD), more commonly known as chronic heartburn. Barrett's esophagus is considered to be a pre-malignant stage and a precursor to esophageal cancer. Some Barrett's patients will advance further to a stage where additional abnormal tissue called dysplasia is present. Dysplasia is known to be the next progressive step toward esophageal cancer and is categorized in stages of low grade and high grade. Barrett's esophagus, dysplasia and esophageal cancer patients are currently diagnosed by an endoscopy of the esophagus with multiple physical biopsies of the inner lining.
High-grade dysplasia is a very critical stage to correctly diagnose because physicians frequently recommend intervention, such as surgical resection or removal of the esophagus if Barrett's esophagus with high grade dysplasia is diagnosed. Unfortunately for the patient, dysplasia is difficult to find and/or diagnose because it is not reliably visible to the physician during standard endoscopy. Because pre-cancerous stages such as dysplasia are not reliably visible during endoscopy, but are such a critical diagnosis, physical biopsies (as many as 20 during one procedure) are performed either randomly or in a geometric pattern throughout the length of the esophagus in hopes of finding the most appropriate tissue to biopsy.
Current medical practice follows the guidelines described below:
- Patients with chronic GERD receive a screening endoscopy of the esophagus to check for Barrett's esophagus - multiple biopsies may be taken;
- Patients with Barrett's esophagus receive an endoscopy with multiple biopsies every two years to check for dysplasia;
- Patients with Barrett's esophagus that has progressed to include low grade dysplasia receive an endoscopy with multiple biopsies every 6 months to check for high grade dysplasia;
- Patients with Barrett's esophagus that has progressed to include high grade dysplasia receive an endoscopy with multiple biopsies every 3 months to check for cancer and/or may be referred for intervention, such as esophageal surgical resection, photodynamic therapy or electrical ablation.
The American Cancer Society estimated that 14,250 new cases of esophageal cancer were diagnosed in 2005 with a greater than 90% mortality rate. The deplorable death rate associated with esophageal cancer is attributed to a lack of early diagnosis allowing the cancer to prpgress to an advanced stage. As previously described, the frequency of endoscopic surveillance for these patients increases as the pre-cancerous stages advance in hope of providing the earliest possible diagnosis. Using the current medical guidelines for esophageal cancer surveillance, the US market for actual WavSTAT Systems use is estimated at more than 2 million procedures annually.
SpectraScience is currently conducting a clinical study using its WavSTAT Optical Biopsy System for the detection of pre-cancerous and cancerous tissue in the esophagus. Studies have been performed at the Mayo Clinic (Rochester, MN) and the University of California San Francisco (San Francisco, CA). Results of the study are being used to complete a proprietary tissue recognition algorithm software program which will be used in a large-scale clinical trial.
Results of the pre-clinical study suggest that the clinical utility of the WavSTAT Optical Biopsy System will improve the physician's accuracy to detect and/or distinguish esophageal cancer and pre-cancerous dysplasia, dramatically reduce the number of physical biopsies taken, analyze tissue in real time and significantly improve the random chance approach currently used to find esophageal pre-cancers or cancers.
The LUMA Cervical Imaging System, is a non-contact optical imaging device that provides a clinician with accurate results in less than a minute. The LUMA System creates an image of the entire cervix overlaid with a visual map of the suspected disease areas. The non-contact illumination probe, with a disposable cover coded for single use, is positioned near the outer opening of the vaginal speculum. The optical scan is a simple, hands-free operation that provides a marked improvement in disease detection over the use of colposcopy alone. As the LUMA System adds negligible time to the standard exam, it is ideal for use in high-volume OB-GYN practices, clinics and hospitals, where a rapid definitive diagnosis is required.