Digital Pathology and AI: Now and in 2025
Experts Nathan Buchbinder and Julianna Ianni discuss digital pathology and AI trends in 2024—and what the next year may hold
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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
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?
FDA Watch: 23andMe Continues to Spearhead Direct-to-Consumer Marketing of LDT Genetic Tests
From - Laboratory Industry Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
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…
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…
