FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
Subscribe today for access to
Articles and Reports
Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
Breach Notification Violation Ends in $475,000 Settlement
...
This content is for Paid Members only.
Register
Register
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…
Coalition Promotes cfDNA-based Noninvasive Prenatal Testing
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Discussion Paper Synthesizes Stakeholder Feedback on LDT Regulation
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
LCDs Demonstrate Evolving Coverage of Molecular Diagnostics
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
FDA Synthesizes Feedback on LDTs in New Discussion Paper
From - National Intelligence Report
Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a…
OIG Updates Threshold for Nominal Value Gifts
From - National Intelligence Report
Just as the civil monetary penalties have gotten an update to adjust for inflation so too have the thresholds for…
DOJ Surveys False Claims Victories for 2016
From - National Intelligence Report
As we closed out the calendar year, the U.S. Department of Justice (DOJ) reflected on its successes for the fiscal year 2016 (FY 2016) which ended…
Labs Beware: New Rules Impose Harsher Civil Monetary Penalties
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here
Semiannual OIG Report to Congress Outlines Challenges as Well as Successes
...
This content is for Paid Members only.
Register
Register
Already a member? Log in here