FDA Pilot Reduces Risks Linked to Lab-Developed Tests in Cancer Diagnostics
U.S. Food and Drug Administration
Program aims to facilitate consistent performance of in vitro diagnostic tests, better oncology drug selection, and improved patient care
Lab Developed Tests
Medical Community Urging Congress to Remove the VALID Act
Miriam Bergeret, MSc
The VALID Act would block patients from accessing essential diagnostic tests
Current Challenges Facing Lab Developed Tests
Pallavi Upadhyay, PhD
Though challenging, creating lab developed tests is crucial for molecular diagnostics labs
Accelerating Lateral Flow Assay Development
nanoComposix
Lateral flow assays are an inexpensive solution for preventative medicine
Clinical Labs in the Spotlight: Compliance Is More Important Than Ever
Kimberly Scott
Dr. Steffini Stalos discusses common business and regulatory challenges and provides advice to achieving compliance
Changes to FDA Oversight of Lab-Developed Tests
Kimberly Scott
The decision to revoke FDA oversight of LDTs is no longer clear after HHS removed its initial statement
Study Models Economic Impact of Proposed Law to Regulate High-Risk Diagnostic Tests
Massachusetts General Hospital
It's the first evidence-based analysis of how new proposed regulation of LDTs would affect health care costs
FDA Suggests Complete Overhaul of IVD Regulation
Kimberly Scott
Proposal of a single regulatory pathway for kits and LDTs spurs controversy