PARIS — Physicians over the last three years have quickly adopted a pill-sized capsule equipped with a micro-video camera as an alternative to traditional endoscopy for the small bowel and built a $100 million market for Given Imaging (Yokneam, Israel).
Now the company is doubling its bet, introducing a double-ended capsule carrying two cameras.
It is a deceptively simple product change that could bring a jackpot-sized payoff for Given Imaging if physicians adopt this procedure for its targeted application — screenings for colorectal cancer (CRC).
“Entering the colonoscopy market suddenly makes the small-bowel procedure seem like a niche market,” said J.P. Galmich, MD, of the Centre Hospitalier Universitaire de Nantes at a press conference during United European Gastroenterology Week (UEGW) here last week, where Given Imaging announced preliminary results from an eight-center clinical study comparing PillCam Colon with traditional colonoscopies.
Back in the small bowel, the single-view PillCam SB, as well as the new competing EndoCapsule from Olympus (Tokyo), might point up or down as it enters the tract, but in neither case does it reduce the effectiveness of the visualization of colon mucosa in that narrow space.
As the camera continues its journey and passes to the colon, the capsule is tumbling in this larger space, and though it continues to capture images, it can not deliver a complete view with its single perspective.
The double-ended PillCam Colon capsule, 5 mm longer than the small-bowel model, tumbles through the relatively large space of the colon, capturing images at two frames per second for each camera with opposing perspectives, effectively doubling the amount of tissue seen by the physician.
The question is whether this is good enough.
The results presented at UEGW from a study of 166 patients with known or suspected colonic disease show the PillCam Colon returned a yield of 72% sensitivity and 80% specificity for detecting polyps, cancers and other pathologies in the colon compared to traditional colonoscopy.
A three-in-four chance of spotting a problem ranks the Given Imaging technique as a more viable alternative than current screening practices for fecal occult blood test, fecal DNA and a double barium enema, though it proved less sensitive than a virtual colonoscopy with a computerized axial tomography scan.
Jacques Deviere, MD, chair of gastroenterology and hepatology at Erasme University Hospital (Brussels, Belgium) and president of the European Society of Gastrointestinal Endoscopy, reported at a UEGW press conference that the prospective study so far shows no adverse events related to the capsule and said investigators concluded that PillCam Colon “could eventually be used for polyp detection and increase compliance for CRC screening.”
He said the study at university hospitals in Spain, Italy, Belgium, France, Germany and the UK is the largest prospective capsule endoscopy study conducted to date, with a target of 329 enrolled patients.
Each patient that ingested the PillCam Colon video capsule also underwent a colonoscopy once the capsule was excreted. Independent physicians performed the exams and were blinded to each other’s results. Significant findings were defined as at least one polyp measuring 6 mm or three or more polyps of any size.
A colonoscopy continues to be the “gold standard” for screening, but the expense and the fact that most adults worldwide are very reluctant to undergo this invasive and uncomfortable procedure is where Given Imaging finds an opportunity.
National Cancer Institute (Bethesda, Maryland) studies estimate compliance with regular CRC screenings is less than 10% of persons in the U.S. over the age of 50.
This older population, steadily growing in every country of the Western hemisphere, is at risk for CRC, the second-leading killer of men after lung cancer, and also among women after breast cancer.
Another sales advantage for Given Imaging as it sets out to create a new market for capsule camera endoscopy is that CRC develops over many years and an individual needs to undergo a test ever few years to aid early detection. The earlier the disease is detected, the higher the chance a person will live five years after treatment, the critical threshold for measuring cancer survival.
The Centers for Medicare & Medicaid Services (Baltimore) reported the number of colonoscopies among patients increased 42% from 2000 until 2002 to 3.1 million per year following widespread media promotion of the risks of CRC. Though clinics extended services to Saturdays to meet demand, patients still wait several months.
“It’s fine to say everyone should have a colonoscopy,” John Bond, MD, chief of gastroenterology at the Veterans Affairs Medical Center in Minneapolis, told the New York Times, ‘”But we are talking about 70 million people. It is unclear whether that is even feasible in the U.S.’”
Where direct costs for a colonoscopy are $1,500 in the U.S. and just under €1,000 in the big five markets of western Europe, the PillCam procedure runs about €600 ($900). A patient undergoes the same diet and laxative preparation for both procedures.
The patient is not sedated for the pill camera, and in fact can go about a normal routine during the approximately 10 hours required for the pill to exit the body.
A significant difference between a colonoscopy and the capsule camera is that images with an endoscope are taken in a digestive tract inflated with air during the procedure, resulting in astonishingly sharp color images.
The pill camera needs a liquid to travel through the digestive tract, and the more clear the liquid, the better the images. While typically more blurred and softer than the vivid colonoscopy images, studies show the pill camera is effective in producing images for visual diagnosis and disease detection.
“There is no sedation of the patient, no tubes, no inflation of the tract and, this is key, no exposure to radiation,” said Dr. Stanislas Chaussade, MD, head of gastroenterology at Hopital Cochin (Paris). “The PillCam Colon shows great promise to improve patient compliance to CRC screening.”
The unknown factor in calculating the revenue potential for Given Imaging is the impact of emerging biotechnologies for CRC screenings. Point-of-care disposable assays that use either DNA biomarkers or protein-based analysis have shown strong sensitivity for detecting cancers and specificity for CRC.
Currently Given Imaging’s pill camera for the colon is priced against a traditional colonoscopy, but could the emergence of a reliable chemical test upset this valuation?
Galmich told Medical Device Daily, “It is highly unlikely such biochemical tests, even disposable, would be offered at disposable prices.”
He said these tests return a high level of false-positives, which brings the physician back to the need to visually examine the mucosa to confirm a diagnosis.
Here the camera capsule provides results better than any other alternative to colonoscopy and, “significantly the procedure could reduce as much as 75% the number of colonoscopies needed among a population,” he said.
Deviere added, “Having the procedure while you are at home can be very attractive for people. If you have ever shared a toilet every five minutes in a gastroenterologist’s office waiting for a colonoscopy, you will appreciate this fact.”