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
Diagnostic Testing and Emerging Technologies
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
Pandemics: Prediction, Prevention, and Response
Recent efforts to forecast the next infectious disease outbreak and steps labs can take to ensure they’re prepared.
Sepsis: Diagnosis on a Deadline
New molecular tests and diagnostic support technologies can help labs detect sepsis earlier, faster, and with greater accuracy
Celebrity Power to Drive Testing Extends Beyond ‘Angelina Jolie Effect’
From - Diagnostic Testing & Emerging Technologies
The power of celebrity impacts health decisions and drives testing decisions beyond the "Angelina Jolie effect." A study published in the…
Decoding Quality Terminology
There is a lot of talk about quality these days, but there is often confusion around quality terminology
Lean Six Sigma is Not Quality
By Jennifer Dawson, MHA, LSSBB, DLM(ASCP) bio
Now before the entire industry lynches me for the sacrilege of the title of this article, let me explain what I mean. I have known Lean Six Sigma skeptics and outright haters and trust me…
Protein Patterns Investigated for Markers of Early Ovarian Cancer
From - Diagnostic Testing & Emerging Technologies
The combination of liquid chromatography and tandem mass spectrometry enabled the discovery of four biomarkers holding promise to become…
By the Numbers: Lab Injury and Exposure Data
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Finding information about the number of Laboratory Acquired Infections (LAIs) and other laboratory injuries in the United States is difficult…
Companion Diagnostics Driving New Model for Pharma-Dx Partnerships
US oncology patients are missing out on targeted therapies due to a combination of testing "quality gaps" and slow test diffusion