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Understanding CLIA and Its Crucial Role in Diagnostic Development
Clinical Laboratory Improvement Amendments (CLIA) is a set of regulations established by the United States government to ensure the quality, accuracy, and reliability of clinical laboratory testing. These regulations are vital for diagnostic development, as they...
Existing FDA-approved blood test for colorectal cancer screening, ColoHealth™, formerly known as Epi proColon.
Existing FDA-approved blood test for colorectal cancer screening, ColoHealth™, formerly known as Epi proColon. ColoHealth™ has been on the market since 2016 as the first and only FDA-approved blood test for colorectal cancer screening. Recently rebranded by New Day...
Development of an algorithm combining blood-based biomarkers, fecal immunochemical test, and age for population-based colorectal cancer screening
Mathias M. Petersen, Jakob Kleif, Jason Liggett, Morten Rasmussen, Lars N. Jørgensen, Jesper Vilandt, Jakob B. Seidelin, Carla M.T. Beertsen, Annemieke C. Heijboer, Claudia Jaensch, Peter Bondeven, Kåre A. Gotschalck, Uffe Schou Løve, Susan H. Gawel, Berit Andersen,...
OPEN OPPORTUNITIES
HUMAN RESOURCES AND OPERATIONS MANAGER – Knoxville, TN (On-site Only) About the Job Reporting to the Chief Operating Officer, the Human Resources and Operations Manager at New Day Diagnostics. plays a pivotal role in managing the daily operations and administrative...
Colorectal Cancer Awareness Month: New test for prevention and early detection
As Colorectal Cancer Awareness Month 2024 comes to a close, Further Together host Michael Holtz, a 12-year survivor of stage IIIB colorectal cancer, talks to Eric Mayer and Jessica Etheridge, CEO and director of marketing and branding, respectively, for...
Living East TN-New Day Diagnostics with New Screening Tool for National Colorectal Cancer Awareness Month
From Living East Tennessee KNOXVILLE, Tenn. (WATE) — March is National Colorectal Cancer Awareness Month and one group is bringing awareness to the significant development of a blood-test for colorectal cancer. This test is the first of its kind and will offer...
New Year brings exciting opportunities for New Day Diagnostics
From: Teknovation Author: Tom Ballard The long-term vision involves everything from R&D to commercialization with testing at the heart of the services the company will provide. The new year brings exciting new opportunities for New Day Diagnostics...
The Role of ISO 13485:2016-Certified QMS in the Lifecycle of a Diagnostic Device
Introduction The development and commercialization of diagnostic devices are a complex endeavor that involves a multitude of steps, from the initial conceptualization to market launch and post-market surveillance. Given the critical role diagnostic devices play in...
New Day Diagnostics Announces Approval of Purchase Agreement by Epigenomics’ AG Extraordinary General Meeting
KNOXVILLE, Tenn., September 14, 2023--New Day Diagnostics is pleased to announce that the Extraordinary General Meeting of Epigenomics AG (Frankfurt General Standard: ECX1), a molecular diagnostics company focused on blood testing for the early detection of cancer,...
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