Becker's ASC Review

65 GASTROENTEROLOGY FDA grants Check-Cap investigational device exemption for its prep-free CRC screening test By Eric Oliver T he FDA granted Check-Cap's C-Scan an investigational device exemption March 15 that will allow the test to launch a clinical study in the U.S. The C-Scan test is a capsule-based screening technology used to detect polyps before they turn into cancer. The test uses an ultralow-dose X-ray capsule and a proprietary software system to generate a map of the inner lining of the colon as it travels through the gastrointestinal tract. The test requires no bowel preparation and is noninvasive. The test, however, is not a colo- noscopy replacement and all positive C-Scan tests should be followed by a colonoscopy. Check-Cap will launch a U.S.-based trial later this year to evalu- ate test performance in average-risk individuals. Alex Ovadia, CEO of Check-Cap, said, "We believe that this highlights the FDA's recognition of C-Scan as an alternative method to address the significant unmet need for patient- friendly CRC screening, in particular since it enables the detec- tion of CRC polyps before they may turn into cancer." News of the approval boosted the company's stock price from around $1.50 to $4.04 at market open March 15. n One GI expands into Kentucky and Indiana By Patsy Newitt M emphis, Tenn.-based One GI acquired Gastroenterolo- gy Health Partners, a group with practices in Louisville, Ky., and Southern Indiana, the company announced April 22 Founded in 2012, GHP represents a merger of three GI groups. It's the largest independent GI practice in Kentucky, comprising 16 physicians and 12 advanced practice providers. With this acquisition, One GI now boasts a portfolio of practices throughout Tennessee, Mississippi, Ohio, Kentucky and Indiana. Founded in April 2020, the company is quickly growing — it acquired two providers earlier this year. One GI is a GI management services organization that partners with GI practices to provide capital and management services. n Colorectal cancer, private equity & more: GI trends in 2021 By Eric Oliver T he year started strong for gastroenterology with several topics defining the specialty's first quarter. Key developments in the specialty: 1. Colorectal cancer developments take center stage. As the U.S. recognized March as National Colorectal Awareness Month, several developments on the disease have taken the main stage: • e American College of Gastroenterology updated its 2009 guidelines around CRC screening, making 21 recom- mendations. ACG emphasized the importance of screen- ing, alternative testing, and potentially lowering the age to start CRC screening. • A study published in Clinical and Experimental Gastro- enterology examined CMS' colonoscopy quality measure, finding it may be inaccurate. • A study published in Clinical Gastroenterology and Hepatol- ogy identified the first risk factors behind early-onset CRC screening. • e COVID-19 pandemic may cause more than 10,000 people to die over the next decade due to delayed care. 2. Private equity starts strong. e new year has coincided with a rapid increase in PE investment in the gastroenterol- ogy space. ere have been nine deals so far, but the biggest rumors have been around the potential sale of Miami-based Gastro Health. Audax is expected to sell the first platform in the space this year. 3. Blood-based tests take a beating. Despite earning FDA approval, Epigenomics's Epi proColon, a blood-based screening test, continues to face hurdles. In January, CMS said it would not reimburse for the test, and ACG supported that decision in its recent guideline update. 4. Other emerging trends. Several other developments oc- curred recently: • e American Gastroenterological Association updated its clinical practice guideline on treating refractory Helico- bacter pylori. • e FDA approved AbbVie's biologic therapy Humira to treat moderate to severe ulcerative colitis in pediatric patients. • A study published in JAMA Network Open found that au- tomated text message reminders did not increase colonos- copy attendance or bowel preparation quality. • CRH Medical reached a deal to be acquired by Well Health for $369.2 million. n

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