Clinical Genomics and Quest Diagnostics Extend Collaboration to Provide InSure® ONE™, a Fecal Immunochemical Test for Colorectal Cancer Screening Programs

Bridgewater, NJ – Thursday, November 1, 2018

Clinical Genomics, a leading innovator of tests for colorectal cancer, and Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced a 5-year extension to their U.S. supply agreement for the InSure® ONE™ fecal immunochemical test (FIT). This agreement builds upon a long standing collaboration to provide InSure FIT and the new InSure ONE FIT for colorectal cancer screening programs.

Clinical Genomics manufactures FIT tests, including InSure ONE, which Quest provides to physicians and organized provider groups across the United States. These provider groups include specialized programs to improve screening adherence rates for Accountable Care Organizations (ACOs) and other organizations focused on improving quality metrics under value-based care models. Quest is also an investor in the company. Under the agreement, Quest will continue to offer broad access to both the Insure FIT and Insure ONE FIT products in the U.S.

“We are pleased to continue this important partnership with Quest Diagnostics ensuring that screening programs have broad access to InSure ONE, an easy to use FIT that may lead to improved patient compliance,” says Betsy Hanna, Chief Commercial Officer, Clinical Genomics.

“Barriers to screening often delay or prevent early diagnosis,” said Kristie Dolan, General Manager, Oncology, Quest Diagnostics. “Insure ONE FIT helps overcome several of these screening barriers to prompt earlier screening. Our collaboration with Clinical Genomics will ensure that patients and providers in the U.S. continue to have broad access to the innovative Insure FIT and the new InSure ONE FIT.”

InSure ONE is an FDA 510(k) cleared FIT for detecting 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.

Unlike other FIT’s, InSure ONE is the only test that is performed using toilet water collected from a single bowel movement. InSure ONE employs a patented brush sampling method which has been preferred by many doctors and patients for more than 15 years. A water sample is collected from the toilet bowel 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.

Annual FIT is recommended by the American Cancer Society (ACS) for screening programs to detect the early signs of adenomatous polyps, precursors to cancer, and colorectal cancer. Recently, the ACS updated its recommendations lowering the screening age from 50 to 45 years. FIT, along with colonoscopy, is also recommended as a ‘Tier 1’ preferred test for colorectal cancer screening programs by the U.S. Multi-Society Task Force (MSTF). When considering large, organized colorectal cancer screening programs, the U.S. MSTF also recognizes that given the annual nature of FIT and the performance characteristics of this assay in identifying blood in the stool, FIT is “more effective and less costly” than the use every 3 years of FIT-fecal DNA, approved by FDA specifically for use in colorectal cancer screening.1

Colorectal cancer is the second leading cause of cancer death in the United States, with more than 140,000 people per year expected to be diagnosed with the disease and an estimated 50,000 who will die from it. According to U.S. Preventative Service Task Force recommendations, screening for colorectal cancer in adults who are 50 to 75 years old and at average risk 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.
1. Rex DK, U.S. MSTF Consensus Guideline, Gastroenterology 2017; 153:307-323

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 used to detect lower GI bleeding for screening in healthy adults, InSure® ONE™, a one sample FIT used to detect lower GI bleeding, and COLVERA™, a proprietary liquid biopsy blood test identifying circulating tumor DNA for detection of residual disease and early detection of recurrence in post-treatment patients. 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.

About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 45,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.


Kim Gorode, Quest Diagnostics (Media): 973-520-2800
Shawn Bevec, Quest Diagnostics (Investors): 973-520-2900
Betsy Hanna, Clinical Genomics (Media): 908-300-8673 (ext. 316)