The advantages and real-life examples of molecular tests
Many laboratories around the world have adopted expanded diagnostic testing capabilities to address the coronavirus pandemic and are now seeking ways to expand testing with additional workflows for infectious disease syndromic panels, pharmacogenomic analysis, oncology testing, and more.
Access two papers authored by the Arizona State University College of Health Solutions:
Paper 1: An introduction to diagnostic testing in laboratories
- Learn about different diagnostic assays and why they are important for laboratories in clinical, hospital, academic, and specialized settings
- Describes potential areas for growth in the use of LDTs, potential benefits, as well as what a laboratory must do to implement one
- Defines the FDA approved IVD, potential benefits, as well as the role of IVDs in the U.S. healthcare system
- Discusses regulations that must be understood by laboratories that offer LDTs, as well as manufacturers of IVDs
Paper 2: Preparing for and implementing a laboratory-developed test
- Describes how a laboratory can prepare to design and implement a laboratory-developed test (LDT)
- Outlines the typical steps of LDT implementation and identify key questions that must be addressed at each stage of the process
About Arizona State University College of Health Solutions
Recognized by U.S. News & World Report as the country’s most innovative school, Arizona State University (ASU) is where students and faculty work together to advance research, strategic partnerships, entrepreneurship, and economic development.
The ASU College of Health Solutions is dedicated to translating scientific health research and discovery into practical interventions. The Master’s Degree in Biomedical Diagnostics is designed to address the role of diagnostics in clinical and research decision making. With the only program of its kind in the world, ASU is dedicated to maintaining its position as the academic and intellectual center of the diagnostics industry.
