Overlooked Clinical Biomarkers Play Important Role in Determining and Predicting COVID-19 Disease Severity
In an exclusive interview, pathologist Frederick (Fritz) Kiechle, MD, PhD, reviews biomarker changes and related clinical laboratory testing at different disease stages of COVID-19.
HHS Invokes Defense Production Act to Speed SARS-CoV-2 Antigen Test Production
Details fall into place for invoking the Defense Production Act for SARS-CoV-2 antigen test production.
Contact Tracing Could be Augmented by Tracking Variants of SARS-CoV-2 Says Dartmouth Researcher
Joel Lefferts, PhD, of the Geisel School of Medicine at Dartmouth and Clinical Genomics and Advanced Technology (CGAT) at Dartmouth-Hitchcock Medical Center (DHMC), explains how SARS-CoV-2 virus genome sequencing and tracking the variants will complement contact tracing.
CDC Provides Updated Interim Guidance for Rapid Antigen Testing for SARS-CoV-2
CDC continues to change SARS-CoV-2 diagnostic testing guidance.
CMS Releases New and Modified CLIA Requirements and Penalties for Noncompliance
Points of interest from CMS-3401-IFC and CLIA requirements modified in August 2020.
New Open Source Saliva-Based SARS-CoV-2 Diagnostic Test Intends to Reduce Lab Supply Chain Stress
What the open source protocol means to COVID-19 testing laboratories.
HHS Finds that FDA Does Not Have the Authority to Regulate Laboratory Developed Tests
New guidance for those seeking approval or clearance of, or an EUA for, an LDT, and for those opting to use LDTs in their laboratories without FDA premarket review or authorization.
FDA Issues Four New Warning Letters for Adulterated and Misbranded COVID-19 Tests
The four companies implicated in recent FDA warning letters over unauthorized COVID-19 tests. What did these tests have in common?
Ohio Governor’s False Positive COVID-19 Result Impacts Public Perception of SARS-CoV-2 Antigen Testing
What happened with Ohio Gov. Mike DeWine’s coronavirus test.
Dartmouth Researcher Discusses Implications SARS-CoV-2 Mutations will Have on Testing by Clinical Laboratories
In an exclusive interview, Dr. Joel Lefferts, a genomics specialist at Dartmouth’s Geisel School of Medicine, discusses coronavirus research around sequencing a small subset of the SARS-CoV-2 virus.