Revisiting the technical validation of tumour biomarker assays: how to open a Pandora's box

New tools and approaches to newborn screening: ready to open Pandora's box?

The landscape of newborn screening (NBS) is changing as new tools are developed. We must acknowledge that NBS is a very important and extraordinarily positive initiative especially for rare and serious inherited disorders; however, lessons learned from current NBS should guide the future of NBS as we enter the era of "omics" that will expand NBS for many other genetic disorders. In this article...

Blood pressure-measuring devices: time to open Pandora's box and regulate.

Rose and colleagues 1 found that the DINAMAP models 1846-SX and 1846-SX/P (Critikon Corp) systematically skip 14 values of systolic blood pressure, of which some (140 and 160 mm Hg) are critical in the diagnosis and treatment of hypertension. The findings of Rose and colleagues1 come as no surprise. The DINAMAP 8100 failed to pass validation.2 Furthermore, to protect their intellectual and comm...

Rapid SARS-CoV-2 RT-LAMP assay setup using gene construct design approach

Background and Objective: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is still an ongoing challenge in health system worldwide. Molecular detection methods including reverse transcription loop-mediated isothermal amplification (RT-LAMP) can help cutting off the transmission chain of the virus. In this study, prompt setting up of the RT-LAMP assays were investigated using ge...

Opening Pandora's box: How technologies of communication and cognition may be shifting towards a 'psycho-civilized society'

Evaluation of Candidate Biomarkers of Type 1 Diabetes via the Core for Assay Validation

Recognizing an increasing need for biomarkers that predict clinical outcomes in type 1 diabetes (T1D), JDRF, a major funding organization for T1D research, recently instituted the Core for Assay Validation (CAV) to accelerate the translation of promising assays from discovery to clinical implementation via a process of coordinated evaluation of biomarkers. In this model, the CAV facilitates the...