FDA Approves Optical Biopsy System for Assessing Colon Polyps

ROCKVILLE, Md—The FDA has approved the marketing of the Optical Biopsy System (SpectraScience, Inc.), a laser-based technique designed to assist physicians in deciding whether certain colon polyps are precancerous and should be removed. The company chose the trademark name Optical Biopsy System after the FDA refused to accept the name "Virtual Biopsy System" for its product.

The adjunct diagnostic system operates through an endoscope and can be used during either sigmoidoscopy or colonoscopy. It consists of a laser, an optical fiber, analytical software, and a user-interface console.

Laser light is transmitted through the optical fiber and aimed at a suspicious polyp. The polyp absorbs the light and re-emits it through the fiber to a computer, where computations performed by the software indicate whether the polyp has the potential to become malignant. The analysis takes less than 1 second.

The Optical Biopsy System is meant, "to evaluate polyps less than 1 cm in diameter that the physician has not already decided to remove," the FDA said in announcing its approval of the device. "When used by physicians who base removal of polyps on their visual assessment, the device helps them to decide which polyps should be removed and sent for microscopic examination and which can safely be left alone. It is not intended to be used as a stand-alone device and should not be used to replace the physician's judgment in the removal of colonic polyps."

Use of the Optical Biopsy System is restricted to physicians trained in endoscopy and in the use of the new system.

The FDA based its approval of the device on clinical studies conducted by SpectraScience and on the recommendation of the Gastroenterology and Urology Devices panel of its Medical Devices Advisory Committee.

Study Results

In 101 patients with 135 polyps examined at five medical centers in the United States, researchers found that the Optical Biopsy System increased the accuracy of physicians in identifying precancerous polyps from 82% to 96%. However, the accuracy of physicians in correctly identifying noncancerous polyps fell from 50% to 33% when they used the device. No adverse events resulted from using the laser system.

"Our initial marketing efforts will be focused on performing outcome-based studies with key physician opinion leaders to promote the adoption of the technology and obtain the necessary clinical data to establish both foreign and domestic reimbursement," said Chet Sievert, Jr., SpectraScience's president and chief executive officer.

The Optical Biopsy System uses a proprietary laser-induced fluorescence technology. "The company believes that its technology represents an enabling platform that maybe used to distinguish normal vs diseased tissues in other areas of the body," SpectraScience said in a press release about the FDA's approval. In addition to colon applications, the company has performed clinical studies of the device for the detection of cancer in the esophagus.