Pivotal study reports InSure® FIT™ offers superior sensitivity for colorectal cancer screening

InSure FIT more sensitive than OC FIT-CHEK and Hemoccult II SENSA for detecting advanced colorectal neoplasia


Bridgewater, NJ, February 1, 2018

Clinical Genomics, manufacturer of fecal immunochemical tests for colorectal cancer screening programs, announces that in a study of more than 1000 people screened for colorectal cancer, InSure FIT was significantly more sensitive than two leading fecal occult blood tests for detecting colorectal cancer.

Published in The American Journal of Gastroenterology*, the study compared three fecal occult blood tests: InSure FIT, OC FIT-CHEK, and Hemoccult II SENSA (a highly sensitive guaiac FOBT), in 1,006 asymptomatic patients, aged between 50 and 75 years, who also received a screening colonoscopy. The authors reported that “InSure FIT was statistically significantly more sensitive than both the OC FIT-CHECK and Hemoccult II SENSA.” Sensitivities for detecting advanced colorectal neoplasia was highest for InSure FIT at 26.3%, followed by OC FIT-CHEK at 15.1%, and Hemoccult II SENSA at 7.4%. Specificities were high for all three tests, ranging from 96.8% to 98.6%.

“We are pleased to see the publication of this pivotal study, which provides important evidence that not all FOBT’s are equal and that physicians should consider using highly sensitive and specific FITs, such as InSure FIT, in colorectal cancer screening programs” says Mark Boyle, President of Clinical Genomics IVD.

InSure FIT is an FDA 510(k) cleared and CLIA waived test that detects human hemoglobin from blood in stool, as an aid in the detection of lower gastrointestinal bleeding. A number of medical conditions may be associated with lower gastrointestinal bleeding, including colorectal cancer, iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, and adenomas.

InSure FIT has been preferred by both doctors and patients for more than 15 years due to its unique brush sampling design, offering unsurpassed accuracy and ease of use. A water sample is collected from the toilet bowl by simply brushing the surface of the stool to release any blood into the surrounding water, rather than having to collect a stool sample or smear feces, an unpleasant requirement normally associated with other at-home collection methods.

Clinical Genomics recently received FDA 510(k) clearance for its one-stool sampling format, InSure® ONE™, making it even easier for patients to complete the sample collection. InSure ONE is also now available.

Annual FIT is recommended by the American Cancer Society for screening programs for the early detection of adenomatous polyps, precursors to cancer, and colorectal cancer, in individuals of average risk starting at age 50 years. FIT, along with colonoscopy, is also recommended as ‘Tier 1’ preferred tests for colorectal cancer screening programs by the U.S. Multi-Society Task Force.

* Shapiro J.A., et.al. A comparison of fecal immunochemical and high-sensitivity guaiac tests for colorectal cancer screening Am. J. Gastroenterology advance online publication 10 October 2017: doi10.1038/ajg.2017.285 https://www.ncbi.nlm.nih.gov/pubmed/29016558

About Colorectal Cancer

Colorectal cancer is the second leading cause of cancer death in the United States, with more than 130,000 people per year expected to be diagnosed with the disease and as many as 49,000 who will die from it. According to the 2016 U.S. Preventative Service Task Force recommendations, screening for colorectal cancer in adults who at average risk, aged 50 to 75 years, reduces colorectal cancer mortality. Many people, however, are not screened according to guidelines, and studies show aversion to colonoscopy and other methods may factor into decisions not to screen. The disease is often highly treatable when caught in early stages.

About Clinical Genomics

Clinical Genomics is dedicated to improving patient outcomes through early detection of colorectal cancer. Clinical Genomics products span the full spectrum of colorectal cancer testing, including InSure® FIT™, a fecal immunochemical test for screening in healthy adults, to COLVERA™, a proprietary blood test identifying circulating tumor DNA in patients post-treatment for early detection of recurrence and residual disease. Clinical Genomics is committed to developing and delivering solutions that provide physicians and their patients with information to help guide earlier and better treatment decisions in cancer care management. Clinical Genomics continues to apply its proprietary innovation in molecular pathology to commercialize other diagnostic tools in other cancer types.