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...
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,...
New Day Diagnostics LLC Reinforces Commitment to Early Cancer Intervention with Its intention to Acquire the Assets of Epigenomics AG
KNOXVILLE, Tenn.--(BUSINESS WIRE)--New Day Diagnostics LLC is pleased to announce that it has entered into an asset purchase agreement with Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), a molecular diagnostics company focused on blood testing for the...
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.
NAVIGATING REGULATORY APPROVAL WITH A CRO IN IVD DEVELOPMENT
The development and commercialization of medical devices, including diagnostics, require a significant investment of time, resources, and expertise. To navigate the complex regulatory approval process and bring a device to market, many medical device companies partner with contract research organizations (CROs). In this article, we will explore the role of CROs in the diagnostics industry, the benefits of working with a CRO, and the different services that CROs provide to help companies bring their diagnostic devices to market.
EDP Biotech Announces New Hire Sam Libby to Lead Rapid Company Growth and Expansion Opportunities
Sam Libby joins EDP Biotech Corporation as Head of Mergers & Acquisitions and Corporate Development to expand investments and create new corporate relationship opportunities as the company grows. KNOXVILLE, Tenn., January 12, 2023--(BUSINESS WIRE)--EDP...