Clinical Genomics and Quest Diagnostics announce FDA 510(K) clearance of InSure® ONE™

At-home collection, one-day fecal immunochemical test that meets American Cancer Society guidelines and HEDIS quality measures for lower gastrointestinal bleeding screening programs

A number of medical conditions may be associated with lower gastrointestinal bleeding, including colorectal cancer

BRIDGEWATER, N.J. and SECAUCUS, N.J., Nov. 13, 2017 (GLOBE NEWSWIRE) — Clinical Genomics, a private company and Quest Diagnostics (NYSE:DGX), the world’s leading provider of diagnostic information services, today announced FDA clearance of InSure® ONE™, a convenient  at-home collection, fecal immunochemical test (or FIT) intended to detect blood in stool, that may improve compliance for screening programs.

Clinical Genomics manufactures InSure FIT tests, including InSure ONE, which Quest provides to physicians and organized provider groups, including through specialized programs with Accountable Care Organizations (ACOs), across the United States. InSure ONE is expected to be commercially available in early 2018.

InSure ONE detects human hemoglobin from blood in fecal samples to 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 One requires sample collection from one bowel movement by the patient, versus the two samples required by InSure FIT, its predicate test. Unlike other FITs, InSure ONE only requires a sample of water from the toilet bowl. The toilet bowl water is collected after brushing the surface of the stool to release any blood into the surrounding water.

Annual FIT is guideline-recommended 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. However, despite the availability of FIT and other screening options, low patient participation rates continue to be a major challenge for screening programs.

“InSure ONE was specifically designed with the user in mind,” said Mark Boyle, President of Clinical Genomics IVD. “A test that is easier for the patient to use is far more likely to be employed, which in turn may enhance screening rates and earlier detection of medical issues when they are more likely to be successfully treated.”

“InSure ONE is a significant step forward for the InSure product line and FIT testing in general because it addresses several factors that may inhibit screening,” said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. “As a leader in oncology diagnostic services, we look forward to facilitating access to this new, more convenient product. It will be a particularly valuable asset in our consultative solution for ACOs, through which we provide supportive services to enhance screening rates so ACOs are more likely to meet quality metrics and associated value-based reimbursement.”

Quest Diagnostics provides several capabilities to address gaps in care and enhance the patient experience, including patient outreach programs, to encourage colorectal cancer screening using the InSure product line. Organized provider groups, including ACOs, whose targeted populations fulfill screening guidelines and associated quality scores may be more likely to achieve positive medical outcomes and increased incentive based economics under value-based care.

FIT, along with colonoscopy, was recently recommended as ‘Tier 1’ preferred tests for colorectal cancer screening programs by the U.S. Multi-Society Task Force. This panel of expert gastroenterologists representing the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy, considers “FIT an essential element of colorectal cancer screening armamentarium for all practitioners”. According to the U.S. MSTF recommendations, FIT is a non-invasive, and low cost test that has been shown to be highly effective when repeated annually. Annual testing by FIT is also recommended by the American Cancer Society.

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.

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 43,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.  For more information, please visit or call 1.866.MY.QUEST.

50th Anniversary: In 2017, Quest Diagnostics celebrates 50 years of life-changing results. To learn about our legacy of accomplishments and quest to improve healthcare in the future, visit

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 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.

Forward-Looking Statement
The statements in this press release which are not historical facts may be forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date that they are made and which reflect management’s current estimates, projections, expectations or beliefs and which involve risks and uncertainties that could cause actual results and outcomes to be materially different. Risks and uncertainties that may affect the future results of the company include, but are not limited to, adverse results from pending or future government investigations, lawsuits or private actions, the competitive environment, changes in government regulations, changing relationships with customers, payers, suppliers or strategic partners and other factors discussed in the company’s most recently filed Annual Report on Form 10-K and in any other of the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, including those discussed in the “Business”, “Risk Factors”, “Cautionary Factors that May Affect Future Results” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of those reports.



Kim Gorode, Quest Diagnostics (Media): 973-520-2800
Shawn Bevec, Quest Diagnostics (Investors): 973-520-2900


Mark Boyle, Clinical Genomics (Media): 908-300-8673 (ext. 300)