Diagnostics & Imaging Week
PARIS — The Millennium Research Group (Toronto) predicts that capsule endoscopy will “be a highly competitive market in the years ahead.”
The presentation of new ingestible camera capsules during the United European Gastroenterology Week (UEGW) gathering here last week showed modest variations on lighting and wireless transmission features against the market-leading PillCam SB from Given Imaging (Yokneam, Israel), but collectively they demonstrated the potential for further development of these micro-electromechanical systems (MEMs).
Both Given and Olympus (Tokyo) are looking beyond micro-optics and micro-lighting to push the gastric diagnosis envelope further with what Nachum Shamir, CEO of Given, called “a more active capsule.”
He told Diagnostics & Imaging Week that R&D efforts at Given include bidirectional signaling between the capsule and the workstation to control variable frame capture rates, telling the camera to work faster when the capsule is moving quickly, and slower when it slows down or is stopped in the digestive tract for a period.
He said magnetic fields projected around a patient could be used for greater control of the capsule’s direction and mobility during its one-way journey.
Moving beyond detection to treatment, Given is developing prototypes for an intelligent pill where radio signals could trigger the release of on-board pharmaceuticals.
Finally, capsules can be equipped with biosensors sensitive to specific cellular activity. The camera could detect and locate these “beacons” for later exploration and treatment with endoscopy. The capsule also may be a vehicle for a pharmaceutical intervention.
In late 2006, Given was named project coordinator for a European Union-funded program titled “Nano-based capsule-Endoscopy with Molecular Imaging and Optical biopsy” (NEMO).
The NEMO project consortium includes Zarlink Semiconductor (Ottawa, Ontario), Fraunhofer Institute for Biomedical Engineering (St. Ingbert, Germany), Israelitic Hospital and Indivumed (Hamburg, Germany), Imperial College of Science, Technology and Medicine (London), ITC Research Institute (Trento, Italy) and the Hebrew University of Jerusalem.
NEMO is estimated to run €4.7 million ($7 million), with the European Commission funding €2.8 million ($4.2 million).
NEMO has the goal of increasing patient compliance with currently recommended screening guidelines by developing an advanced cancer screening system that is patient-friendly, highly sensitive and specific for early detection of cancer.
NEMO also is a nexus for MEM development in Europe, converging of optical technologies with nano-technologies, biosensors and maneuvering technologies to create a unique PillCam capsule endoscope capable of secretion analysis and the detection of marked and deep tissue disorders.
The consortium suggests the combination of the image and molecular analysis to mark a tumor may provide a novel and effective medical device for mass screening for gastrointestinal cancers.
In other news from the conference:
A point-of-care test for inflammation of the digestive tract will be launched by Calpro (Lysaker, Norway) in early 2008.
Arne Roseth, a company founder and practicing gastroenterologist, said the rapid test was approved by the FDA in June 2006, and he is awaiting a reimbursement ruling for early November that will trigger product launch.
Roseth told D&IW that he expects reimbursement levels to be set for $45 for Medicare, $60 for private insurers.
The assay determines levels of calprotectin in a stool sample. There is a strong history of studies demonstrating the reliability of calprotectin as a biomarker of gastrointestinal inflammation and as a differential diagnostic for inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS).
The benefit of a “quick-and-dirty” test is providing a physician with both qualitative and quantitative readings on calprotectin to determine if the patient requires further endoscopic examination.
In addition to disease detection, the rapid test can be used to follow a patient through drug therapy to determine if the mucosal lining is healing. Finally, the test can determine if a patient is likely to experience a relapse by tracking increasing levels of calprotectin.
The test will be sold for $25, Roseth said, representing a substantial savings if unnecessary procedures are avoided. He noted that a histology fee can be $189, and the average cost of an endoscopic procedure is $1,650.
Roseth said Calpro generated $2 million in sales this year, “and we are not losing money.”
Calpro promoted the product during the UEGW conference with the release of an abstract from Aker University Hospital Trust (Oslo, Norway) that concluded the point-of-care device correlates 95% with traditional enzyme-linked immunosorbent assay tests used by clinical laboratories.
A secondary focus for the study was determining performance in the general practice setting and its usefulness for monitoring disease activity.