News & Resources
Why You Should Choose a CRO with ISO 13485 Certification for Your Diagnostic Device Development
Introduction The field of diagnostic devices is complex, highly regulated, and fundamentally vital to public health. When designing, developing, and commercializing a new diagnostic product the stakes are high. Partnering with a CRO that holds an ISO...
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,...
New Day Diagnostics LLC Reinforces Commitment to Early Cancer Intervention with its Intention to Acquire the Assets of Epigenomics AG
New Day Diagnostics LLC is set to revolutionize cancer diagnostics through a strategic asset purchase agreement with Epigenomics AG. This move enhances their mission to provide cost-effective early detection products, with a focus on Epi proColon, a groundbreaking colorectal cancer screening tool. CEO Eric Mayer sees vast potential in the methylated DNA biomarker, and the acquisition aims to accelerate its commercialization. Jens Ravens of Epigenomics expressed confidence in the synergy between the companies, highlighting the promise of accessible blood-based cancer diagnostics. New Day Diagnostics remains dedicated to making healthcare more accessible and convenient, using the Epigenomics assets to further innovate in the diagnostic testing space.
Unveiling the Gut Microbiome: Exploring the Connection Between Gut Health, Inflammatory Bowel Disease, and Colorectal Cancer
Introduction The gastrointestinal (GI) tract plays a vital role in the ability to digest and absorb nutrients from food. The GI tract is inhabited by a diverse community of microorganisms that provide nutrients and protection while breaking down hard to digest foods....
Building a Vertically Integrated Diagnostics Powerhouse: EDP Biotech Corp. and New Day Diagnostics, LLC Announce Asset Merger
KNOXVILLE, Tenn. & BOCA RATON, Fla.--(BUSINESS WIRE)--EDP Biotech Corp. (EDP Biotech) and New Day Diagnostics, LLC (New Day Diagnostics) are pleased to announce their combination, forming a vertically integrated force in the expedited development and...
Inside the World of Diagnostic Research: A Beginner’s Guide to Clinical Trials
Clinical trials are research studies that involve testing new treatments, therapies, and interventions on volunteering participants to determine the effect on human health. They play a crucial role in medical advancements as they help to bring these new drugs,...
Gut Instincts: Understanding the Role of Your Microbiome in Mental Health
Gut Instincts: Understanding the Role of Your Gut Microbiome in Mental Health Gut health and mental health go hand in hand, according to recent research. These studies have suggested that the trillions of bacteria that live in our gut, collectively known as the gut...
8 Ways CROs Support Regulatory Compliance
Discover the vital role of regulatory compliance in clinical investigations for diagnostics. Learn how adherence to regulations ensures patient safety, diagnostic efficacy, and market access, driving advancements in healthcare. Explore the challenges, benefits, and future perspectives of navigating regulatory compliance in the ever-evolving diagnostic landscape. Click here to unlock the key to safe, effective, and innovative diagnostics.
ColoPlex Biomarker Data Published in Journal of Clinical Oncology
Abstract. Background: Colorectal cancer (CRC) is the third most common cancer worldwide motivating national screening strategies utilizing fecal immunochemical tests (FIT). Blood-based biomarkers could be an alternative method to increase compliance in population-based screening programs for early detection of CRC. We aimed to identify new blood-based biomarkers that could be potential candidates for use in colorectal cancer screening.