Capital Digestive Care Launches AI-Driven LGI-Flag Algorithm For Predicting Lower Gastrointestinal Disorders Including Colorectal Cancer In The United States

• Capital Digestive Care will help enable widespread patient access to this groundbreaking predictive tool to help identify lower GI disorders earlier and improve outcomes
• Available through the Roche navify^® Algorithm Suite, LGI-Flag uses demographic information and historical CBC test results to flag individuals at risk for lower GI disorders that warrant further investigation
• U.S. launch timed to Colorectal Cancer Awareness Month, underscoring significant need to increase screening rates for this deadly disease

Silver Spring Md /PRNewswire/ - Capital Digestive Care, the largest private gastroenterology (GI) practice in the Mid-Atlantic region, today announced that it is launching LGI-Flag in the United States. Available through the Roche navify Algorithm Suite, LGI-Flag is a groundbreaking AI-driven algorithm used to flag individuals at risk for lower GI disorders that warrant further evaluation. With this launch, the Capital Digestive Care Laboratory – the first GI specialty practice recognized as a Roche Diagnostics Center of Excellence – will now use LGI-Flag to screen eligible patients using electronic health record (EHR) and clinical data repositories, contact those identified as being at risk for colorectal cancer and/or other lower GI disorders, and schedule appropriate follow up (e.g., a colonoscopy).

"Capital Digestive Care is committed to enabling the digital transformation of healthcare, in order to provide a more personalized, convenient and predictive continuum-of-care for patients," said Michael Weinstein, M.D., CEO of Capital Digestive Care. "Our innovative laboratory, along with our end-to-end continuum-of-care model, makes us an ideal organization to bring this highly sensitive and well-validated tool to provide more precise and predictive care to patients. Now, we have a means to more precisely identify those at high risk of lower GI disorders, including colorectal cancer so they may avoid the devastating effects of the disease through increased screening and earlier detection and treatment."

LGI-Flag uses demographic information and historical CBC (complete blood count) test results to flag individuals with CBC patterns that may be associated with an increased risk for lower GI disorders, including but not limited to irritable bowel syndrome (IBS), inflammatory bowel diseases (IBD), and colorectal cancer – the third leading cause of cancer-related deaths in both men and women in the United States.¹

Increasing colorectal cancer screening rates has been a priority in the United States for some time, as outcomes improve significantly when asymptomatic polyps and other early-stage cancers are detected and treated early. The U.S. Preventive Services Task Force (USPSTF) colorectal screening guidelines recommend a colonoscopy every 10 years for adults between the ages of 45 and 75 who are considered to be at low to average risk. In addition, the guidelines recommend a non-invasive stool-based screening test, such as the guaiac-based fecal occult blood test (HSgFOBT) or fecal immunochemical test (FIT) (which are recommended annually) and Stool DNA-FIT (which is recommended every 1-3 years).² However, approximately 32% of age-eligible U.S. adults do not follow the current colorectal cancer screening guidelines³ and only approximately 37% of cases are diagnosed at an early stage.⁴

LGI-Flag can be used on its own to identify patients at increased risk, or with a non-invasive stool-based screening test to provide additional information about an individual's risk and whether they require further evaluation versus a stool-based screening test alone.

"We're excited that through Capital Digestive Care, LGI-Flag will now be offered to a large number of patients in the U.S. to help improve care for people with wide-ranging lower GI disorders and support the critical mission to increase colorectal cancer screening rates," said Moritz Hartmann, Global Head of Roche Information Solutions. "This helps advance that mission by offering a highly effective and clinically validated machine-learning-based algorithm to identify those at increased risk of a wide array of lower GI disorders, including colorectal cancer."

About LGI-Flag
LGI-Flag, developed by Medial EarlySign and available via the navify Algorithm Suite from Roche, is an evidence-based way to identify patients who are at risk for colorectal cancer and other lower GI disorders. The tool requires only a patient's existing CBC results, along with the individual's birth year and gender, to calculate a risk score and flag those in need of follow-up screening.

A prospective real-world study published in the New England Journal of Medicine in 2022 identified patients overdue for colorectal cancer screening and used LGI-Flag to flag those at highest risk for abnormal results.⁵ Patients were then informed of their risk and offered to schedule a colonoscopy to complete their screening. Of those flagged patients, approximately 70% had a significant finding. Overall, colorectal cancer was found in 8% of flagged patients who underwent a colonoscopy and had their results documented, 22% were found to have advanced adenomas (a classification of colon polyps that have a higher likelihood of developing into malignant polyps), and 29% were found to have adenomas/polyps.

"We're proud to now offer LGI-Flag to our large and diverse body of patients to help improve health outcomes without increasing patient burden," said Laura Vivian, Executive Director of Capital Digestive Care Laboratory. "This launch builds upon our existing relationship with Roche Diagnostics and will further advance our ability to seamlessly deliver more personalized and actionable insights to revolutionize care for the patients we serve."

About Capital Digestive Care
Founded in 2009, Capital Digestive Care is the largest private gastroenterology practice in the Mid-Atlantic. Recent partnerships with Gastrointestinal & Liver Specialists of Tidewater and Gastroenterology, Ltd. in Southeastern Virginia have expanded its network to more than 160 physicians and advanced care practitioners who treat a wide range of conditions—from the common complaint of heartburn to the complex management of Crohn's Disease—and offer critical services for the prevention of colon cancer for more than 200,000 patients annually.

With business operations located in Silver Spring, MD, Capital Digestive Care's integrated care model connects its doctors to more than 25 office locations and outpatient surgery centers as well as specialized laboratory services and the largest clinical research program of its kind in the region. For more information, please visit www.capitaldigestivecare.com.