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 Confirms that LOINC Coding of IVD Tests Is Voluntary
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Industry Buzz: Criminal Charges May Spell the End for Theranos
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FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
From - Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
Industry Buzz: LabCorp and Quest Swept Up in Insurance Contract Partner Swap
From - Laboratory Industry Report
Can you imagine Scarlett and Rhett swapping partners with Romeo and Juliet? Something like the laboratory industry equivalent of that scenario took place on…
Top of the News: ANDE Rapid DNA Platform First to Win FBI Approval
From - Laboratory Industry Report
"Great news! The FBI just called."
–Extremely rare phrase almost never uttered except sarcastically…
Market Trends: Genetic Testing Becoming a Hot New Employee Benefit
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FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
Market Report: 2018 Shaping Up as Record Year for Healthcare Industry Mergers & Acquisitions
From - Laboratory Industry Report
While healthcare industry merger and acquisition activity has been on the rise for several years, the early returns suggest that 2018 will be the biggest…
FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
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…