Future of digital assays to resolve clinical heterogeneity of single extracellular vesicles

RTT Morales, J Ko - ACS nano, 2022 - ACS Publications
Extracellular vesicles (EVs) are complex lipid membrane vehicles with variable expressions
of molecular cargo, composed of diverse subpopulations that participate in the intercellular …

Regulation of laboratory-developed tests: a clinical laboratory perspective

JR Genzen - American Journal of Clinical Pathology, 2019 - academic.oup.com
Objectives To provide a clinical laboratory perspective on the Verifying Accurate Leading-
edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if …

Somatic genomic testing in patients with metastatic or advanced cancer: ASCO provisional clinical opinion

D Chakravarty, A Johnson, J Sklar… - Journal of Clinical …, 2022 - ascopubs.org
PURPOSE An ASCO provisional clinical opinion offers timely clinical direction to ASCO's
membership following publication or presentation of potentially practice-changing data from …

Liquid chromatography–tandem mass spectrometry in newborn screening laboratories

MH Gelb, K Basheeruddin, A Burlina, HJ Chen… - International Journal of …, 2022 - mdpi.com
Tandem mass spectrometry (MS/MS) is the most universal platform currently available for
the analysis of enzymatic activities and biomarkers in dried blood spots (DBS) for …

How current assay approval policies are leading to unintended imprecision medicine

R Salgado, AM Bellizzi, D Rimm, JMS Bartlett… - The Lancet …, 2020 - thelancet.com
Pathologists are responsible for selecting the assays for the optimal identification of patients
for targeted therapy. The current paradigm of regulatory assay approval is that when a …

[HTML][HTML] A regulatory science initiative to harmonize and standardize digital pathology and machine learning processes to speed up clinical innovation to patients

HD Marble, R Huang, SN Dudgeon, A Lowe… - Journal of Pathology …, 2020 - Elsevier
Unlocking the full potential of pathology data by gaining computational access to histological
pixel data and metadata (digital pathology) is one of the key promises of computational …

The significance of external quality assessment schemes for molecular testing in clinical laboratories

N Laudus, L Nijs, I Nauwelaers, EMC Dequeker - Cancers, 2022 - mdpi.com
Simple Summary Patients and clinicians often rely on the outcome of laboratory tests, but
can we really trust these test results? Good quality management is key for laboratories to …

Implementing precision medicine programs and clinical trials in the community-based oncology practice: barriers and best practices

JL Ersek, LJ Black, MA Thompson… - American Society of …, 2018 - ascopubs.org
There has been a rapid uptick in the pace of oncology precision medicine advancements
over the past several decades as a result of increasingly sophisticated technology and the …

Proficiency testing of standardized samples shows very high interlaboratory agreement for clinical next-generation sequencing–based oncology assays

JD Merker, K Devereaux, AJ Iafrate… - … of pathology & …, 2019 - meridian.allenpress.com
Context.—Next-generation sequencing–based assays are being increasingly used in the
clinical setting for the detection of somatic variants in solid tumors, but limited data are …

[HTML][HTML] Zinc finger protein 180 induces an apoptotic phenotype by activating METTL14 transcriptional activity in colorectal cancer

L Xu, XJ Chen, Q Yan, XT Lei, HL Liu… - Oncology …, 2024 - spandidos-publications.com
Abstract Zinc finger protein 180 (ZNF180) is a multifunctional protein that interacts with
nucleic acids and regulates various cellular processes; however, the function of ZNF180 in …