Insights & Publications

Insights

Point of Care Testing: A Blessing or a Burden?

Point-of-care testing (POCT) refers to medical diagnostic testing that is performed near the patient, often at the bedside, rather than in a centralized laboratory. This type of testing provides rapid results, allowing healthcare providers to make immediate treatment decisions. POCT devices are typically portable, easy to use, and require minimal training. They are suitable for…

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TriCore’s Mobile Testing Program Ties to its Mission

Monique Dodd, PharmD, PhC, MLS(ASCP)CM, TriCore’s Manager, Enterprise Clinical Solutions and Karissa Culbreath, PhD, D(ABMM) TriCore’s Chief Medical Director, Infectious Disease, were interviewed for this article.   The barriers to accessing healthcare is a major contributor to poor health outcomes and increased healthcare costs in the U.S. TriCore’s footprint across New Mexico has enabled improved…

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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…

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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….

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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…

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