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
FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
From - Laboratory Industry Report
On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to…
Investment Trends: Dx/Tools Venture Capital Keeps Flowing Despite Decline in Early-Stage Investment
From - Laboratory Industry Report
Continuing a four-year trend, total U.S. venture capital investment in health care surged in 2018, reaching a new all-time high of…
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
From - Laboratory Industry Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
Earnings Report: Top Payers Announce Q3 Earnings
From - Laboratory Industry Report
The country's five largest commercial payers posted strong results for the third quarter of fiscal year 2018…
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
From - Laboratory Industry Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
6 Steps to Data-Driven Transformation
By Nir Kaldero bio
We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the…
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
From - Laboratory Industry Report
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use…
Medicare Reimbursement: Part B Lab Payments in Final Year before PAMA
From - Laboratory Industry Report
Part B payments for lab tests in 2017, the final year under the old reimbursement rules, totaled $7.1 billion, up slightly from…
FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry
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Artificial Intelligence: An Automated New World for Labs & Pathology
From - Laboratory Industry Report
Artificial intelligence (AI) and machine learning are making significant inroads in the diagnostics realm. Here are four ways…