scholarly journals Towards Routine Implementation of Liquid Biopsies in Cancer Management: It Is Always Too Early, until Suddenly It Is Too Late

Diagnostics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 103
Author(s):  
Maarten J. IJzerman ◽  
Jasper de Boer ◽  
Arun Azad ◽  
Koen Degeling ◽  
Joel Geoghegan ◽  
...  
Keyword(s):  
Clinical Utility ◽  
Clinical Laboratory ◽  
Genomic Analysis ◽  
Current Evidence ◽  
Liquid Biopsies ◽  
Blood Draw ◽  
Minimum Quality Standards ◽  
Cancer Management ◽  
Alternative Funding ◽  
And Performance

Blood-based liquid biopsies are considered a new and promising diagnostic and monitoring tool for cancer. As liquid biopsies only require a blood draw, they are non-invasive, potentially more rapid and assumed to be a less costly alternative to genomic analysis of tissue biopsies. A multi-disciplinary workshop (n = 98 registrations) was organized to discuss routine implementation of liquid biopsies in cancer management. Real-time polls were used to engage with experts’ about the current evidence of clinical utility and the barriers to implementation of liquid biopsies. Clinical, laboratory and health economics presentations were given to illustrate the opportunities and current levels of evidence, followed by three moderated break-out sessions to discuss applications. The workshop concluded that tumor-informed assays using next-generation sequencing (NGS) or PCR-based genotyping assays will most likely provide better clinical utility than tumor-agnostic assays, yet at a higher cost. For routine application, it will be essential to determine clinical utility, to define the minimum quality standards and performance of testing platforms and to ensure their use is integrated into current clinical workflows including how they complement tissue biopsies and imaging. Early health economic models may help identifying the most viable application of liquid biopsies. Alternative funding models for the translation of complex molecular diagnostics, such as liquid biopsies, may also be explored if clinical utility has been demonstrated and when their use is recommended in multi-disciplinary consensus guidelines.

scholarly journals Technical and Regulatory Considerations for Taking Liquid Biopsy to the Clinic: Validation of the JAX PlasmaMonitorTM Assay

2019 ◽  
Vol 14 ◽  
pp. 117727191982654 ◽  
Author(s):  
Bridgette A Sisson ◽  
Jasmina Uvalic ◽  
Kevin Kelly ◽  
Pavalan Selvam ◽  
Andrew N Hesse ◽  
...  
Keyword(s):  
Liquid Biopsy ◽  
Clinical Utility ◽  
Tumor Tissue ◽  
New Technology ◽  
Invasive Procedure ◽  
Standard Of Care ◽  
Liquid Biopsies ◽  
Blood Draw ◽  
Analytical Test ◽  
The Many

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 PlasmaMonitorTM test.

scholarly journals Clinical Utility of Liquid Biopsy-Based Actionable Mutations Detected via ddPCR

Biomedicines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 906
Author(s):  
Irina Palacín-Aliana ◽  
Noemí García-Romero ◽  
Adrià Asensi-Puig ◽  
Josefa Carrión-Navarro ◽  
Víctor González-Rumayor ◽  
...  
Keyword(s):  
Liquid Biopsy ◽  
Clinical Utility ◽  
Cancer Genetics ◽  
High Sensitivity ◽  
Digital Pcr ◽  
Liquid Biopsies ◽  
Cancer Subtypes ◽  
Cancer Management ◽  
Main Challenge ◽  
Therapeutic Decisions

Cancer is one of the leading causes of death worldwide and remains a major public health challenge. The introduction of more sensitive and powerful technologies has permitted the appearance of new tumor-specific molecular aberrations with a significant cancer management improvement. Therefore, molecular pathology profiling has become fundamental not only to guide tumor diagnosis and prognosis but also to assist with therapeutic decisions in daily practice. Although tumor biopsies continue to be mandatory in cancer diagnosis and classification, several studies have demonstrated that liquid biopsies could be used as a potential tool for the detection of cancer-specific biomarkers. One of the main advantages is that circulating free DNA (cfDNA) provides information about intra-tumoral heterogeneity, reflecting dynamic changes in tumor burden. This minimally invasive tool has become an accurate and reliable instrument for monitoring cancer genetics. However, implementing liquid biopsies across the clinical practice is still ongoing. The main challenge is to detect genomic alterations at low allele fractions. Droplet digital PCR (ddPCR) is a powerful approach that can overcome this issue due to its high sensitivity and specificity. Here we explore the real-world clinical utility of the liquid biopsy ddPCR assays in the most diagnosed cancer subtypes.

Clinical verification of circulating tumor RNA (ctRNA) as novel pretreatment predictor and tool for quantitative monitoring of treatment response in metastatic colorectal cancer (mCRC): A biomarker study of the DEEPER trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS3621-TPS3621
Author(s):  
Yu Sunakawa ◽  
Joshua L. Usher ◽  
Yolanda S Jaimes ◽  
Akihito Tsuji ◽  
Manabu Shiozawa ◽  
...  
Keyword(s):  
Clinical Utility ◽  
Genomic Analysis ◽  
Comparative Trial ◽  
Maintenance Phase ◽  
Circulating Tumor Dna ◽  
Genetic Alterations ◽  
Gene Expressions ◽  
Liquid Biopsies ◽  
Tissue Samples ◽  
Exact Test

TPS3621 Background: A randomized phase II trial, DEEPER (JACCRO CC-13) [NCT02515734], is on-going to evaluate FOLFOXIRI plus cetuximab (cet) vs. FOLFOXIRI plus bevacizumab (bev) in terms of depth of response as primary endpoint in 360 mCRC patients (pts) with RAS wild-type tumors, PS0-1, and no previous chemotherapy. This is a head-to-head comparative trial of 2 key monoclonal antibodies in mCRC treatment; therefore, it would be of interest to perform the biomarker study for developing novel predictors of cet or bev. The clinical utility of circulating tumor DNA (ctDNA) analysis has been largely validated for monitoring during treatment and companion diagnostics after chemotherapy. However, there are few published results regarding ctRNA in cancer treatment. Use of ctRNA from liquid biopsies would enhance tumor profiling through the trending of actionable biomarkers not found in ctDNA, and allow for patient monitoring by measuring dynamic changes in levels of gene expressions. Methods: This study will enroll pts with willing to undergo biopsies of both tissue and blood among participants of the DEEPER trial. The estimated number is 250. The main purpose is to find novel predictors for efficacy of cet or bev in mCRC using liquid biopsies, which are performed to obtain ctDNA and ctRNA at 6 time points: pre-treatment, 8 weeks after treatment start, beginning of maintenance phase in FOLFOXIRI-regimen, progression, before and 8 weeks after 2nd-line treatment. The tissue samples collected before chemotherapy will be used for analyzing intra-tumoral genetic alterations. Associations between analytes in blood/tissue and the clinical outcomes of each treatment (with cet or bev) will be assessed using Fisher’s exact test, Kaplan-Meier curves, and log-rank tests in univariate analyses. We will evaluate on whether transcriptomic analysis in ctRNA could predict treatment efficacy more accurately compared to genomic analysis in ctDNA, and verify the clinical utility of ctRNA testing in mCRC treatment. Accrual will continue until the DEEPER trial is completed. Clinical trial information: UMIN000018412.

scholarly journals Human TERT promoter mutations as a prognostic biomarker in glioma

2021 ◽  
Vol 147 (4) ◽  
pp. 1007-1017
Author(s):  
Branka Powter ◽  
Sarah A. Jeffreys ◽  
Heena Sareen ◽  
Adam Cooper ◽  
Daniel Brungs ◽  
...  
Keyword(s):  
Clinical Utility ◽  
Nucleotide Polymorphism ◽  
Liquid Biopsies ◽  
Single Nucleotide ◽  
Tert Promoter ◽  
Tert Promoter Mutations ◽  
Potential Clinical Utility ◽  
Promoter Mutations ◽  
The Relationship ◽  
Potential Use

AbstractThe TERT promoter (pTERT) mutations, C228T and C250T, play a significant role in malignant transformation by telomerase activation, oncogenesis and immortalisation of cells. C228T and C250T are emerging as important biomarkers in many cancers including glioblastoma multiforme (GBM), where the prevalence of these mutations is as high as 80%. Additionally, the rs2853669 single nucleotide polymorphism (SNP) may cooperate with these pTERT mutations in modulating progression and overall survival in GBM. Using liquid biopsies, pTERT mutations, C228T and C250T, and other clinically relevant biomarkers can be easily detected with high precision and sensitivity, facilitating longitudinal analysis throughout therapy and aid in cancer patient management.In this review, we explore the potential for pTERT mutation analysis, via liquid biopsy, for its potential use in personalised cancer therapy. We evaluate the relationship between pTERT mutations and other biomarkers as well as their potential clinical utility in early detection, prognostication, monitoring of cancer progress, with the main focus being on brain cancer.

scholarly journals Clinical utility of brain stimulation modalities following traumatic brain injury: current evidence

2015 ◽  
pp. 1573 ◽  
Author(s):  
Felipe Fregni ◽  
Shasha Li ◽  
Ana Zaninotto ◽  
Iuri Santana Neville ◽  
Wellingson Paiva ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Brain Stimulation ◽  
Clinical Utility ◽  
Current Evidence

Comparison of UK and European Association of Urology (EAU) guidelines for kidney cancer management

2017 ◽  
Vol 11 (2) ◽  
pp. 132-138
Author(s):  
David Nicol
Keyword(s):  
Kidney Cancer ◽  
European Association ◽  
Treatment Modalities ◽  
Current Evidence ◽  
Specific Strength ◽  
Cancer Management ◽  
Funding Model ◽  
Cancer Networks ◽  
The Uk ◽  
European Association Of Urology

Clinical practice frequently utilises guidelines on how specific conditions should be managed. For urologists in the UK a range of sources are used as guidelines for the management of kidney cancer. These include documents from national bodies such as the National Institute for Health and Care Excellence (NICE), professional bodies as well as those prepared by individual groups of clinicians within regional cancer networks. In this article the European Association of Urology (EAU) guidelines on renal cell carcinoma are compared to guidelines used in the UK for this disease. Broadly consistent variations exist related to regional practice patterns, funding and the currency of the various guidelines. A specific strength of the EAU guidelines is the regular updating of these allowing incorporation of new evidence. These however do not consider the funding model for healthcare of the UK which dictates the availability of some treatment modalities and thus in some areas are not applicable. Current guidelines for kidney cancer developed within the UK are inconsistent and often outdated in terms of evidence sources. Broader use of the EAU guidelines within the economic restrictions of healthcare in the UK may result in a more consistent practise utilising current evidence sources in the management of kidney cancer.

scholarly journals Detecting an ALK Rearrangement via Liquid Biopsy Enabled a Targeted Therapy-based Approach for Treating a Patient with Advanced Non-small Cell Lung Cancer

2018 ◽  
Vol 14 (1) ◽  
pp. 38 ◽  
Author(s):  
Alejandro R Calvo ◽  
Gabriel H Ibarra ◽  
Cecile Rose T Vibat ◽  
Veena M Singh
Keyword(s):  
Liquid Biopsy ◽  
Clinical Utility ◽  
Tumor Tissue ◽  
Molecular Testing ◽  
Tissue Analysis ◽  
Alk Rearrangement ◽  
Blood Draw ◽  
Diagnostic Biopsy

Initial diagnostic biopsy procedures often yield insufficient tissue for molecular testing, and invasive surgical biopsies can be associated with significant cost as well as risk to the patient. Liquid biopsy offers an alternative and economical means for molecular characterization of tumors via a simple peripheral blood draw. This case report describes the ability of liquid biopsy to detect an ALK translocation where tissue analysis by fluorescence in situ hybridization was negative for the genetic alteration. Identification of an ALK rearrangement in circulating tumor cells from a blood specimen led to sequential targeted therapies that included crizotinib followed by alectinib. The patient demonstrated outstanding clinical response during treatment with each of the prescribed ALK inhibitors. This case demonstrates the clinical utility of Biocept’s liquid biopsy to detect actionable biomarkers by surveying the systemic landscape of a patient’s disease where identification of the same genetic drivers may be missed in analyses of heterogeneous tumor tissue.

Design and Performance of a Miniaturized High-Speed Continuous-Flow Analyzer

1974 ◽  
Vol 20 (4) ◽  
pp. 424-427 ◽  
Author(s):  
William E Neeley ◽  
Stephen C Wardlaw ◽  
Helen C Sing
Keyword(s):  
Sample Size ◽  
Continuous Flow ◽  
High Speed ◽  
Clinical Laboratory ◽  
Small Animal ◽  
Sample Volume ◽  
Small Sample ◽  
Reagent Consumption ◽  
And Performance ◽  
Made In

Abstract Design features and performance of a miniaturized high-speed continuous-flow analyzer are described. Special emphasis is made in the design towards a system that is free from the operational and mechanical complexities found in most of today’s advanced systems. Depending on the particular analyses, sample size varies from 3 to 25 µl and reagent consumption is less than 180 µl per sample. Analyses are performed under steady-state conditions at sampling rates of 150 samples per hour with a 2:1 or 3:1 sample-to-wash ratio. The marked reduction in sample size makes the system ideal for microanalyses, especially in the pediatric clinical laboratory, in small animal research, and in any other cases where small sample volume is especially important.

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