Insights & Publications
Insights
The Basics of the FDA’s Proposed Rules for Laboratory Developed Tests
Overview David G. Grenache, PhD D(ABCC), TriCore’s Chief Scientific Officer, and Melissa M. Budelier, PhD D(ABCC), TriCore’s Medical Director of Clinical Chemistry and Toxicology, were interviewed for this article. On September 29, 2023, the Federal Drug Administration (FDA) proposed rules to regulate laboratory developed tests (LDT). These rules could significantly affect patient care and labs…
New Areas of Discovery and Collaboration
Since its inception, TriCore’s Research Institute has experienced steady and continuous growth, emphasizing research in the field of infectious diseases. During the pandemic, the focus was on COVID Emergency Use Authorizations, which were crucial. The Institute is now diversifying to encompass more intricate studies, such as more complex COVID 510(k) submissions and other respiratory viruses….
TRI Partners with Sponsors for 510(k) Submissions
A 510(k) submission is a premarket submission made to the U.S. Food and Drug Administration (FDA) for the purpose of obtaining clearance to market a medical device or instrument in the United States. An in-vitro diagnostic (IVD) medical device manufacturer may need to submit a 510(k) application if it intends to introduce a new IVD…
TriCore Research Institute: A Reliable Partner in Innovation
In the dynamic landscape of medical research and technological advancements, TriCore Research Institute (TRI) has partnered with organizations to make scientific advances in medicine Infectious Disease Research Studies The year 2020 marked a watershed moment for TriCore Research Institute (TRI). The outbreak of the SARS-CoV-2 pandemic underscored the importance of agility and continuity in research…
Right Sample, Right Test, Right Remnant: The Remnant Equation
In the ever-evolving field of clinical research, the utilization of residual clinical samples has emerged as a valuable resource. These biological samples, which are collected during routine medical procedures, hold tremendous potential for advancing scientific knowledge and improving patient care. In this blog post, we will explore the significance of residual clinical samples and their…
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