Regulation and standards

How liquid biopsy and next-generation sequencing fit into the pathology lab of the future

How can pathologists explore the uncharted territory of diagnostic error disclosure?

Anthony Whetton, Director of the Stoller Biomarker Discovery Centre, Manchester, UK

Michael Laposata, co-author of the IoM report, speaks out…

We can argue about how many diagnostic errors happen each year, but we can’t deny that there are too many of them. And when one of those errors is ours, denial is especially inappropriate – but how many of us feel comfortable about a confessional with the patient? In the first installment of a two-part feature, we examine the difficulties around disclosure and communication of diagnostic errors.

FDA issues first-ever approval for liquid biopsy companion diagnostic

What labs need to know about the importance of ISO 15189 accreditation.

New regulations in the US set to change the way LDTs are developed – and could stifle innovation

What is "The Individual Quality Control Plan (IQCP)" and should test sites adopt it?

The secretive diagnostic startup has been making headlines – but not always for the right reasons…