Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
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The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
From - Diagnostic Testing & Emerging Technologies
Antigen typing based on whole-genome sequencing (WGS) can enable more precise matching of blood transfusions, according to a study published online May 17 in…
From - Diagnostic Testing & Emerging Technologies
The health care technology company Concert Genetics (formerly NextGxDx; Nashville, Tenn.) recently released its third edition of…
By Sean McSweeney bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…
From - Diagnostic Testing & Emerging Technologies
Despite existing recommendations, blood culture is overused in patients with suspected, uncomplicated cellulitis, according to a research letter published…
From - Diagnostic Testing & Emerging Technologies
As might be expected, there has been rapid growth in genetic test availability and spending on these tests since 2014. But, comprehensive new collaborative analysis conducted by…
From - Diagnostic Testing & Emerging Technologies
Expanded next-generation sequencing-based carrier screening improves detection of rare and novel pathogenic variants even in…