Virtual Colonoscopy Receives Highest Grade in the New U.S. Preventive Services Task Force Recommendation for Colorectal Cancer Screening

MONROE TOWNSHIP, N.J., Aug. 5, 2016 /PRNewswire/ -- Bracco Diagnostics Inc. (BDI), the U.S. subsidiary of Bracco Imaging S.p.A., a global leading company in the diagnostic imaging business, announced today that The U.S. Preventative Services Task Force (USPSTF) issued a new recommendation to improve the rate of colorectal cancer screening (CRC). Computed tomography colonography (CTC), also known as Virtual Colonoscopy (VC), received an "A" rating as an alternative screening tool to colonoscopy in detecting colon cancer. The USPSTF recommendation was published in the June 21 online edition of the Journal of the American Medical Association. Bracco, a leader in CTC imaging innovation, has been providing two products that are essential components of CTC screenings since 2002.

"Bracco is pleased that the USPSTF has recognized the importance of CTC as a colorectal cancer screening option," said Alberto Spinazzi, MD, BDI Senior Vice President, Global Medical and Regulatory Affairs. "Colorectal cancer, one of the deadliest cancers, has a 90 percent cure rate when detected early. Having CTC recognized as a valid screening tool for the population of adults aged 50-75 years will be a major step forward in accelerating coverage and getting more people screened, thereby increasing early detection and ultimately saving lives."   

The USPSTF defines an "A" rating as a high certainty that the benefit is substantial. This may be a significant step in expanding Medicare coverage policies to cover CTC not only as a diagnostic test but also as a screening test.

"The highest 'A' rating by the USPSTF for colorectal cancer screening includes CTC as a valid direct visualization test," said Judy Yee, MD, FACR, Professor and Vice Chair of Radiology and Biomedical Imaging, UCSF and Chief of Radiology, SF VA Medical Center. "This is essential for allowing more rapid widespread dissemination of this life-saving tool. Although colorectal cancer is preventable in the majority of individuals, only about 50 percent of people who require screening for colorectal cancer undergo testing. CTC offers a less invasive method to screen for colorectal cancer, and as the USPSTF agreed, the best test is one that patients will actually use."

Bracco provides integral products that provide comfort and clarity during CTC procedures: PROTOCO₂L TOUCH^®, the only system for automated insufflation of carbon dioxide (CO₂) in the U.S, and Tagitol^™ V (Barium Sulfate Suspension 40% w/v, 30% w/w), a stool marker, or "fecal tagging" agent.

PROTOCO₂L TOUCH Colon Insufflator is used during CT Colonography exams to obtain optimal colonic distension. The device utilizes automated insufflation of CO_2, which is more rapidly absorbed than room air resulting in less post-procedural discomfort. It's intuitive and user friendly design streamlines insufflation while providing clinicians with real-time results.

Tagitol V Stool Tagging Agent is a low volume radiopaque agent used to improve differentiation of soft tissue intraluminal lesions and retained stool ("fecal tagging"). It provides convenience and simplicity for both clinicians and patients as it comes in three small low-volume 20mL unit doses, has a pleasant apple flavor which is easy to swallow, and can be easily stored.

Spinazzi concludes, "Before USPSTF, CTC had been already recommended by the American Cancer Society, the U.S. Multi-Society Task Force, and the American College of Radiology, as a valid test for CRC screening, involving extremely low doses of radiation and requiring no sedation. The adoption of CTC as a CRC screening option enables Bracco to help radiology departments enhance their workflow efficiencies while optimizing the CTC experience for their patients."

Indications and Usage

PROTOCO₂L TOUCH
The PROTOCO₂L TOUCH Colon Insufflator provides a software controlled insufflation of carbon dioxide during CT Colonoscopy (CTC).  Carbon dioxide is more rapidly absorbed than room air and helps minimize the patient's post-procedure bloating and cramping. The PROTOCO₂L TOUCH insufflator helps reduce staff time during the colon insufflation process and enhances productivity. Automated insufflation helps ensure adequate and consistent distension in a patient- and operator-independent manner. It also features a specially designed small tip for patient comfort, as well as safety features to help protect against over-insufflation.

IMPORTANT SAFETY INFORMATION:
The PROTOCO₂L TOUCH Colon Insufflator administers and regulates carbon dioxide as a distention media to the colon during CTC or Virtual Colonoscopy.

The PROTOCO₂L TOUCH Colon Insufflator should be used only when colon insufflation is indicated, and should therefore not be used for any other treatment.  It should only be used under the direct guidance of a physician experienced in colon insufflation.

Instructions for Use may be obtained by contacting Bracco Diagnostics Professional Services Department at 800-257-5181, option 2.

Tagitol V
Tagitol V is a low-volume radiopaque marker that blends into stool as it forms. With just a 20mL dose with breakfast, lunch and dinner the day prior to the exam, Tagitol V provides immediate, visible identification of retained feces via comparative density analysis, simplifying the distinction between tagged feces and colonic abnormality.

IMPORTANT SAFETY INFORMATION:
Tagitol V is for use in opacifying residual stool in the colon during CTC. This product should not be used in patients with known or suspected gastric and intestinal perforation, or hypersensitivity to barium sulfate or any component of this barium sulfate formulation. Rarely, severe and occasionally fatal allergic reactions have been reported following administration of barium sulfate contrast agents.

Please see full Prescribing Information for Tagitol V at http://imaging.bracco.com/us-en/products-and-solutions/ct-colonography/tagitol-v/prescribing-information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information about Bracco's products, and for full prescribing information, please visit http://imaging.bracco.com/us-en. If you have any questions or require additional information about any Bracco product, please contact Bracco Professional Services at 1-800-257-5181, option 2. 

For questions regarding coding and reimbursement, you can contact our reimbursement hotline at: 1-800-349-1388 or email: [email protected]

PROTOCO₂L TOUCH is manufactured for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 08831. Tagitol is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc.

PROTOCO₂L TOUCH is a registered trademark of E-Z-EM, Inc. Tagitol is a trademark of E-Z-EM, Inc.

About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world's leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.

Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.

The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.

Operational investments have been made in order to achieve top quality, compliant and sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.

Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and USA. To learn more about Bracco Imaging, visit www.braccoimaging.com.

Press Contact:
Kimberly Gerweck
Bracco Diagnostics Inc.
609.514.2249
[email protected]

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SOURCE Bracco Diagnostics Inc.

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