FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
Author Information
Ron Shinkman
Ron Shinkman is a veteran journalist and editor with more than 20 years of experience in the healthcare business realm. He served as Los Angeles bureau chief of Modern Healthcare and also wrote for the Los Angeles and Orange County Business Journals.
Posts by the Author
Dx Deals: Labs Exploring Cryptocurrency Share Their Plans
Know Labs and ProPhase Laboratories discussed plans that in part involve digital currencies
Diagnostics Pipeline: SimplyTest, Becton Dickinson Expand HPV Testing Capabilities
SimplyTest’s saliva-based HPV tests will be marketed to dentists and functional medicine practices
Quest Says It Will Release a More Powerful Alzheimer’s Test in 2026
The assay detects the presence of three different proteins and is slightly more accurate than a test Quest released earlier this year
New Tests Could Make Detecting Lyme Disease Speedier and More Accurate
Current assays often miss diagnoses in the early stages of the disease, delaying treatment
FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
Dx Deals: Labcorp and Roche Enter into Pacts to Distribute Alzheimer’s Tests, Digitize Slides
The technology developed by Roche in recent years seems a good fit for Labcorp’s testing services
Diagnostic Pipeline: Labcorp Uses Chewing Gum Samples to Identify Bone Marrow Donors
The initiative is in conjunction with The Gift of Life registry and Doublemint Gum
Dx Deals: Sonic Healthcare Buys East Coast Lab in First Such US Acquisition Since 2021
Australian firm has grown its overseas operations dramatically in the past decade, except in America
FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
