Expert Q&A: Labs Must Take a Greater Role in Guiding Clinicians About Abnormal Data
Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists
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At-Home Genetic Testing: The Good, The Bad, and The Ugly
Direct-to-consumer (DTC) genetic testing has risen in popularity in recent years—but is it all it’s cracked up to be?
Clinical Lab Education: The Role of Virtual Reality
How virtual reality technologies can support clinical laboratory education efforts and what leaders should know about implementation
Diagnostic danger in the lab: Time to reform how we process orders
Recent report examining 10,000 claims to understand the key drivers of medical malpractice suits found 52 percent involved lab-related errors.
Theranos & Its CEO Settle Stock Fraud Charges with SEC
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Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
From - Laboratory Industry Report
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements…
FDA Watch: Personalized Medicine Approvals Continue to Flow
From - Laboratory Industry Report
After a slow start to the year, new product business picked up significantly in the past four weeks. Here's a rundown…
Industry Buzz: ACLA Goes for Kill in PAMA Lab Fees Challenge Case
From - Laboratory Industry Report
Attorneys for the American Clinical Laboratory Association asked the federal court for summary judgment in its lawsuit challenging…
FDA Watch: Off-Label Marketing Rule Put Back on Ice & Extra Comment Time for CLIA Waiver Proposals
From - Laboratory Industry Report
For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing…
The Year in Dx VC Investment: Dx/Tools Outperforms Health Care & Liquid Biopsy/AI/ Informatics Outperforms Dx/Tools
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Genetic Profiling: Study Casts Doubt on Cost-Effectiveness of Leading Breast Cancer Recurrence Assay
From - Laboratory Industry Report
Among the many genetic profiling assays entering the commercial market, few have been more successful than Genomic Heath's Oncotype DX, which is now covered by most of …
FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway
From - Laboratory Industry Report
A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including…
LDTs: Top 10 New FDA Diagnostic Approvals of 2017
From - Laboratory Industry Report
The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo…