FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
Already a member? Log in here
CLIA-nir
Subscribe today for access to
Articles and Reports
New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
Already a member? Log in here
How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
Already a member? Log in here
Theranos Settles with CMS and Arizona Attorney General
From – National Intelligence Report
After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to…
Already a member? Log in here
Labs Stop VA from Allowing APRNs to Perform Lab Tests
From – National Intelligence Report
The laboratory sector has successfully fought a Department of Veterans Affairs (VA) rule that would have allowed advance practice registered nurses (APRNs) to “perform and supervise” lab testing. Numerous organizations, including…
Already a member? Log in here
CMS Grants International CLIA Certificate to ImmunID for Laboratory in France
...
Already a member? Log in here
CLIA Certificate Granted for Laboratory in France
From – National Intelligence Report
As recently reported in Laboratory Industry Report (see “Inside the Laboratory Industry,” Laboratory Industry Report, p. 4, 3/17/16), the diagnostics industry is going…
Already a member? Log in here
Government Scrutiny of Theranos Increases
...
Already a member? Log in here
CMS Releases New CLIA-Waived Tests, Billing Codes
...
Already a member? Log in here
ACMG and AMA Coalition Make LDT Oversight Recommendations to Congress
...
Already a member? Log in here
FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
...
Already a member? Log in here
More FDA Workshops Focus on NGS Technology
...
Already a member? Log in here