FDA sets meeting to review CT colonography

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A virtual who's who of CT colonography (CTC) is en route to the Washington, DC, area for a September 9 joint committee meeting of the U.S. Food and Drug Administration (FDA) that will discuss the fate of CTC screening for asymptomatic individuals.

Monday's joint meeting in Silver Spring, MD, involves the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee. Participants will review the use of CTC (also known as virtual colonoscopy) in colorectal cancer screening of asymptomatic individuals and will discuss current evidence on the procedure's risks and benefits. Speakers will focus on new techniques and evidence, radiation risks, and the use of CTC compared to other screening tests, among other topics.

Virtual colonoscopy screening continues to await Medicare reimbursement, though several private payors cover it. A move to secure reimbursement was stymied on the federal level by a 2009 decision from the U.S. Centers for Medicare and Medicaid Services (CMS), which declined to approve reimbursement.

In explaining its decision, CMS cited the need for additional evidence on radiation risks, extracolonic findings, and proof of the technique's efficacy in seniors. Virtual colonoscopy advocates, who now say they have provided everything necessary to satisfy the demand for additional evidence, are once again pressing for federal approval of the exam and reimbursement.

"There has been clear validation of screening CTC performance for the detection of polyps and cancers and additional performance data has been published," Dr. Judy Yee wrote in an email to AuntMinnie.com. "Hopefully the FDA will see that the benefit of screening CTC in reducing the number of cases of colorectal cancer largely outweighs any theoretic radiation risk."

Yee is professor and vice chair of radiology and biomedical imaging at the University of California, San Francisco; chief of radiology at the San Francisco Veterans Affairs Medical Center; and a member of the American College of Radiology's Colon Cancer Committee.

Controversy in 2010

But given that CMS controls Medicare reimbursement and the FDA doesn't, why is the agency holding the meeting? It's not clear from premeeting materials issued by the FDA, but it's possible that the meeting is related to a controversy that erupted in 2010, in which some FDA scientists claimed that their concerns over radiation exposure in VC procedures were glossed over in favor of imaging manufacturers who sought regulatory clearance for their products.

What the FDA did say is that participants on Monday will offer advice that will help the FDA consider evolving research on virtual colonoscopy, as well as inform the FDA's continuing regulation of the devices used to perform it.

Discussion questions will cover the potential benefits (including test performance characteristics and VC's impact on total number of patients screened) and safety issues (including radiation risk and extracolonic findings) of screening asymptomatic individuals with virtual colonoscopy.

Panelists will also be asked to offer their views of the technology in light of available evidence, and members of the public are invited to attend an open public hearing from 1:45 p.m. to 2:45 p.m. The meeting will be held at White Oak Conference Center, 10903 New Hampshire Ave., in Silver Spring, MD.

Attendees will include Yee; Dr. Peter Lurie, acting associate commissioner of the FDA; Dr. Perry Pickhardt from the University of Wisconsin; Dr. Abraham Dachman from the University of Chicago; Dr. Amy Berrington de Gonzáles from the U.S. National Cancer Institute; and Dr. Ronald Summers, PhD, from the U.S. National Institutes of Health.

More information is available on the FDA's website. The meeting will also be webcast live on Monday.

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