30 April 2020
Advances key development milestones for the Trident Program
Further strengthens strategic alliance with Quest Diagnostics focused on the Trident Program for CRC screening
BRIDGEWATER, N.J. — April 30, 2020 — Clinical Genomics (“CG” or the “Company”), a provider of advanced cancer diagnostic solutions, including liquid biopsy tests, today announced key business updates related to Trident, the Company’s first-line Colorectal Cancer (“CRC”) screening blood test program, and its strategic alliance with Quest Diagnostics (NYSE: DGX) (“Quest”), the world’s leading provider of diagnostic information services.
Trident Program for CRC Screening
- Potential to develop a first-line CRC screening blood test.
- With data from 1,621 subjects, presented at United European Gastroenterology Week(1), the Trident Program has one of the largest validation data sets of any potential first-line blood test. These data demonstrate performance well within the range of sensitivity and specificity of current tests included in USPSTF guidelines for CRC screening(2).
- Engaged with the U.S. Food and Drug Administration (“FDA”) and the Centers for Medicare and Medicaid Services (“CMS”) to finalize clinical study design with the goal of securing U.S. Premarket Approval (“PMA”) and a National Coverage Determination (“NCD”).
Strategic Alliance with Quest Diagnostics
- Executed an amendment to its strategic alliance agreement with Quest, including an increased investment in the Company. The amendment serves to further leverage the combined capabilities of both organizations in support of Quest’s planned U.S. commercialization of the Trident Program.
- The alliance also expands the Company’s commercialization rights for the Trident Program and COLVERA® for CRC monitoring outside the United States, Mexico, United Kingdom, and India.
“These recent key advancements toward a pivotal study aimed at approval for commercialization will enable us to achieve our mission to save lives and reduce healthcare costs by providing easy-to-use and affordable tests for the detection and monitoring of colorectal cancer,” stated Betsy Hanna, Chief Executive Officer of Clinical Genomics.
“Quest’s national network of laboratories, 2,250 patient service centers and employer population health solutions can provide broad access to any first-line blood test for CRC screening,” concluded Hanna.
“Quest is committed to ensuring that patients and providers in the U.S. have broad access to innovative colorectal cancer diagnostic services,” said Kristie Dolan, General Manager, Oncology, Quest Diagnostics. “Our continued collaboration with Clinical Genomics aligns with this commitment by advancing diagnostic innovations that aid in early diagnosis, which is shown to improve patient outcomes.”
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 from screening to post-treatment monitoring. 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.
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 Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 46,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.
About Colorectal Cancer
Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer related deaths in the United States, with more than 140,000 people per year expected to be diagnosed with CRC and as many as 50,000 succumbing to the disease. For patients who survive, 30-50% will experience a recurrence, most within the first two to three years of primary treatment. On average, the lifetime risk of developing colorectal cancer is about one in 23 for men and women combined, however, this varies widely according to individual risk factors.
Future Matters and Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements that address expectations or projections about the future, including statements about product development, market position, expected expenditures and financial results, are forward-looking statements. Some of the forward-looking statements may be identified by words like “expects,” “anticipates,” “plans,” “intends,” “projects,” “indicates,” and similar expressions. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. These statements are not guarantees of future performance and involve a number of risks, uncertainties and assumptions. Accordingly, the Company’s actual results or performance may differ significantly, positively or negatively, from forward-looking statements made herein. Unanticipated events and circumstances are likely to occur. Factors that might cause such differences include, but are not limited to, anticipated funding proving to be unavailable; intense competition in the market resulting in lower than anticipated revenues or higher than anticipated costs; and general economic conditions, such as the rate of employment, inflation, interest rates and the condition of the capital markets. This list of factors is not exclusive. The Company undertakes no obligation to update any forward-looking statements.
Investor Relations for Clinical Genomics
Lisa M. Wilson In-Site Communications, Inc.
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