FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Clinical Diagnostics Insider
(formerly Diagnostic Testing and Emerging Technologies)
Keep up to date on new and emerging diagnostic tests, testing trends and opportunities, and disruptive technologies
Building a Home for Health Equity
The laboratory’s role in reaching underserved patient populations: an interview with Richard Levenson, Keisuke Nakagawa, and Michele Mitchell
Bringing the Lab to the Patients
Actions clinical laboratories can take to better reach underserved communities, raise the lab’s profile, and increase health equity for all
Removing Racial Inequalities in Lab Referrals
Clinical laboratory professionals must consider how race affects test referrals and what they can do to combat existing inequities
Diversity, Equity, and Inclusion: Beyond the Checklist
Working toward greater equity and access to careers in the clinical lab
Choosing and Using the Right Compliance Solution
Factors laboratories should consider when evaluating their compliance challenges, needs, and goals to select compliance solutions
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
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
Expert Q&A: Lessons Learned from a Total Laboratory Automation Project
Clinical Microbiology division head Jeff Fuller, FCCM, discusses his clinical laboratory’s recent automation transformation and offers tips to ensure success
CDC Releases Recommendations to Address Rising Syphilis Cases
Key updates from the CDC’s new lab recommendations for syphilis testing.
Diagnostics Pipeline: More AI-Reliant Platforms Being Approved by the FDA
Such assays rely more on imaging and computer power than tissue samples to make diagnoses.
Expert Q&A: Key Issues and Developments in Clinical Lab Automation
Laboratory leaders from Geisinger discuss key lab automation developments in their organization.
