‘Full Speed Ahead’ with Test Results? Not So Fast
Lab scientists using testing equipment too quickly brings up training concerns in discussions at recent ADLM conference
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
Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible
Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening
Removing Restrictions to Germline Testing
With the global cancer burden growing, is a universal germline genomic testing approach the key to more effectively combating the disease?
Anatomy of a Fall
Examining what led to record low BB/TM ABPath certification examination pass rates in 2022
Lab Company Takes Rare Step to Promote Heart Disease Test
Publishing peer-reviewed studies to tout the economic benefits of medical devices is fairly commonplace, but rare for a laboratory company
MCED: A New Screening Paradigm?
Multicancer early detection tests—and their promise of comprehensive, minimally invasive screening—are catching the eye of labs and lawmakers
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
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
