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
New Project Aims to Provide Legal Guidance Needed to Do Business in Genomics
From - National Intelligence Report
Technology changes faster than the laws designed to regulate it. Thus, while DNA testing has changed medicine and fueled growth in…
FDA Watch: Agency Okays Marketing of Zika Test for First Time
From - National Intelligence Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different…
DOJ Explains What It Wants from a Compliance Program
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Case of the Month: Physicians Come Under Fire for Taking Blood Processing Fee Kickbacks from HDL
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New OIG Report Confirms that Labs Are Still on the Enforcement Radar
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Medicare Coverage: NGS Testing of Early-Stage Cancer Patients Is Back in Play
From - National Intelligence Report
The reimbursement outlook for those who provide next generation sequencing (NGS) testing to early-stage cancer of Medicare patients with…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - National Intelligence Report
Case: One of the biggest Medicaid diagnostics fraud schemes in recent memory has resulted in multiple convictions, including&…
Changes in hazardous waste management: the Generator Improvement Rule
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
If you haven't heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the…
Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
From - National Intelligence Report
As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval…