US approval for colon camera pill looks a Given second time round

All attempts to unseat endoscopy as the gold standard for detecting intestinal conditions such as cancer have met with ignominious failure. One company has managed to carve out a niche, though, in patients who are unable to undergo the procedure: Given Imaging.

The Israeli company has developed the PillCam, which as its name suggests is a tiny camera in a capsule swallowed whole by the patient. A version designed to image the oesophagus and another for the small intestine are already approved, but in the longer term the company’s future rests on a sister product, PillCam COLON. The FDA said no to the first-generation version, but an updated PillCam COLON looks set for US approval later this year.

Sufficient

A secondary analysis of a subset of data from PillCam COLON’s pivotal trial has indicated that the device can detect optical colonoscopy-confirmed adenomas with a sensitivity and specificity of 88% and 82% respectively for tumours at 6mm or larger, and with sensitivity and specificity of 92% and 95% respectively for those 10mm or bigger.

This is, of course, not as good as colonoscopy itself, which explains Given’s strategy of aiming for approval in patients who cannot be examined with that technique, such as those with inflammatory bowel disease or bleeding or who are at risk from sedation.

Analysts from Cantor Fitzgerald said they had a “high level of confidence that these results are sufficient for FDA approval for a diagnostic indication”. Around 5-10% of patients who require colonoscopy are found to be unsuitable for it. Analysts at Morningstar estimate that this population numbers more than 2 million in the US.

Instead of colonoscopy, these patients are currently imaged with CT scans. A second trial comparing CT colonography with PillCam COLON suggested that both technologies are effective, according to Given, but the PillCam “tends to detect more polyps”. If the device is approved by the FDA, Given should be able to point to these data to spur uptake.

Motherlode

The company does plan to seek approval for the general population, putting the technology in direct competition with colonoscopy – eventually. Calling an indication for general screening “the motherlode”, Morningstar analysts wrote: “The firm has indicated it would continue to pursue the screening label, but we are concerned that the current PillCam COLON may not be up to the task.” The company may have to develop a future iteration of PillCam COLON in order to win approval for the expanded indication.

The product could have a price advantage. The PillCam devices are thought to cost around $500 each, whereas it usually costs over $800 to perform a colonoscopy. Given’s product is also rather more pleasant for the patient: once the capsule is swallowed it transmits images to a detector worn by the patient as they go about a normal day.

The only other player in capsule endoscopy is the Japanese electronics giant Olympus, although its technology can only image the small intestine rather than the colon. Olympus has just 3% of the US capsule market. Given, by contrast, “has benefited from being the first mover in the area of capsule gastrointestinal imaging and continues to hold more than 80% share of the capsule GI diagnostic market”, according to Morningstar.

US approval of PillCam COLON in patients who cannot undergo colonoscopy would not add significantly to Given’s market share. Approval for screening, whether of this iteration of the device or the next, would. The company has achieved much over the last few years; it might yet hit that motherlode.

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com or follow @LizEPVantage on Twitter

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