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
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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
Discordant Results of Next Gen Tumor Profiling Raise Concerns
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Theranos Announces Settlement Agreements with CMS and Arizona Attorney General
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FDA Reports “Significant Progress” in Diagnostics Development
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Reports Indicate Faster FDA Approval Processes
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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…
Test Kits Included in Class 1 Devices Exempt from 510k Filing
From - National Intelligence Report
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks that…
FDA Grants Approval for 23andMe DTC Genetic Test
From - National Intelligence Report
23andMe and the U.S. Food and Drug Administration (FDA) announced last week that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for…
Draft Legislation Proposes New Category for LDTs
From - National Intelligence Report
House of Representatives members Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) are looking for feedback on a discussion draft of legislation called the…
CMS, OIG Reps Address PAMA, Fraud Enforcement at ACLA Annual Meeting
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OIG and DOJ Provide Tips for Determining Effectiveness of Compliance Programs
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