Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
From - Diagnostic Testing & Emerging Technologies
Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report…
From - Diagnostic Testing & Emerging Technologies
The case has been made repeatedly over the past few years regarding the need to increase physicians' genomics knowledge. Now, for the first time…
From - Diagnostic Testing & Emerging Technologies
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used…
From - Diagnostic Testing & Emerging Technologies
The application of pharmacogenomics (PGx) into routine, clinical care remains very limited, despite its potential to improve drug and…
From - Diagnostic Testing & Emerging Technologies
Patients at risk for tuberculosis (TB) infection should be assessed with newer tests, including interferon-gamma release assays (IGRAs) and molecular diagnostics, according to…
From - Diagnostic Testing & Emerging Technologies
A constant refrain within the diagnostics industry is a need for standardization. Rapidly developing technology and testing methods, the call for interoperability, and the vast amount of …