The standard of care in oncology has been genomic profiling of tumor tissue biopsies for the treatment and management of disease, which can prove to be quite challenging in terms of cost, invasiveness of procedure, and potential risk for the patient. As the number of available drugs in oncology continues to increase, so too does the demand for technologies and testing applications that can identify genomic alterations targetable by these new therapies. Liquid biopsies that use a blood draw from the diseased patient may offset the many disadvantages of the invasive procedure. However, as with any new technology or finding in the clinical field, the clinical utility of an analytical test such as that of the liquid biopsy has to be established. Here, we review the clinical testing space for liquid biopsy offerings and elucidate the technical and regulatory considerations to develop such an assay, using our recently validated PlasmaMonitor test.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360476PMC
http://dx.doi.org/10.1177/1177271919826545DOI Listing

Publication Analysis

Top Keywords

liquid biopsy
12
technical regulatory
8
regulatory considerations
8
liquid
4
considerations liquid
4
biopsy clinic
4
clinic validation
4
validation jax
4
jax plasmamonitor
4
plasmamonitor assay
4

Similar Publications

Circulating tumor cells (CTCs) play a pivotal role in cancer metastasis and hold considerable potential for clinical diagnosis, therapeutic monitoring, and prognostic evaluation. Nevertheless, the limited quantity of CTCs in liquid biopsy samples poses challenges for comprehensive downstream analysis. In vitro culture of CTCs can effectively address the issue of insufficient CTC numbers.

View Article and Find Full Text PDF

Background: Age-related macular degeneration (AMD) is a significant factor causing blindness in adults. However, the clinical diagnosis of AMD is relatively challenging, due to the shortcomings of the existing clinical examination methods and the latent period of retinal damage before macular degeneration becomes apparent. This study aims to explore the potential of extracellular vesicles (EVs) protein chips for early diagnosis of AMD using patients' plasma samples.

View Article and Find Full Text PDF

Immunophenotypic analysis on circulating T cells for early diagnosis of lung cancer.

Biomark Res

December 2024

Department of Microbiology and Immunology, Chonnam National University Medical School, Hwasunup, Jeollanamdo, 58128, Republic of Korea.

The immune system continuously interacts with tumors, possibly leading to systemic alterations in circulating immune cells. However, the potential of these cancer-associated changes for diagnostic purposes remains poorly explored. To investigate this, we conducted a comprehensive flow cytometric analysis of 452 peripheral blood mononuclear cell (PBMC) samples from 206 non-small-cell lung cancer (NSCLC) patients, 100 small-cell lung cancer (SCLC) patients, 94 healthy individuals, and 52 benign lung disease (BLD) patients.

View Article and Find Full Text PDF

Detection of a novel DNA methylation marker panel for esophageal cancer diagnosis using circulating tumor DNA.

BMC Cancer

December 2024

Department of Molecular Pathology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, No 127, Dongming Road, Zhengzhou, 450008, Henan, China.

Background: Esophageal cancer (ECa) is one of the most deadly cancers, with increasing incidence worldwide and poor prognosis. While endoscopy is recommended for the detection of ECa in high-risk individuals, it is not suitable for large-scale screening due to its invasiveness and inconvenience.

Methods: In this study, a novel gene methylation panel was developed for a blood-based test, and its diagnostic efficacy was evaluated using a cohort of 304 participants (203 cases, 101 controls).

View Article and Find Full Text PDF

Novel biomarkers are needed to better identify-and distinguish-heart failure with preserved ejection fraction (HFpEF) from other clinical phenotypes. The goal of our study was to identify epigenetic-sensitive biomarkers useful to a more accurate diagnosis of HFpEF. We performed a network-oriented genome-wide DNA methylation study of circulating CD4 T lymphocytes isolated from peripheral blood using reduced representation bisulfite sequencing (RRBS) in two cohorts (i.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!