Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Sisson BA

PROVIDER: S-EPMC6360476 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Technical and Regulatory Considerations for Taking Liquid Biopsy to the Clinic: Validation of the JAX PlasmaMonitor<sup>TM</sup> Assay.

Sisson Bridgette A BA Uvalic Jasmina J Kelly Kevin K Selvam Pavalan P Hesse Andrew N AN Ananda Guruprasad G Chandok Harshpreet H Bergeron Daniel D Holinka Lauren L Reddi Honey V HV

Biomarker insights 20190201

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 ...[more]

PMID: 30745794

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Project description:ObjectivesThe main goals were to provide normal reference ranges for fractional limb volume as a new index of generalized fetal nutritional status, to evaluate the reproducibility of fractional fetal limb volume measurements during the second and third trimesters of pregnancy, and to demonstrate technical considerations for this technique.MethodsThis was a prospective, cross-sectional study of gravid women during mid to late pregnancy. Fractional limb volumes were based on either 50% of humeral or femoral diaphysis length. Each partial volume was subdivided into five equidistant slices that were centered along the mid-arm or mid-thigh. Slices were traced manually to obtain fractional arm (AVol) or fractional thigh (TVol) volume. Reproducibility studies were performed, using Bland-Altman plots, to assess blinded interobserver and intraobserver measurement bias and agreement. Selected images were chosen to demonstrate technical factors for the acquisition and analysis of these parameters. Reference charts were established to describe normal ranges for AVol and TVol.ResultsThree hundred and eighty-seven subjects were scanned to include 380 AVol (range, 1.1-68.3 mL) and 378 TVol (range 2.0-163.2 mL) measurements between 18.0 and 42.1 weeks' menstrual age. No gender differences were found in these soft tissue measurements (AVol, P = 0.90; TVol, P = 0.91; Mann-Whitney test). Intraobserver mean bias +/- SD and 95% limits of agreement (LOA) for fractional limb volumes were: 2.2 +/- 4.2% (95% LOA, - 6.0 to 10.5%) for AVol and 2.0 +/- 4.2% (95% LOA, - 6.3 to 10.3%) for TVol. Interobserver bias and agreement were - 1.9 +/- 4.9% (95% LOA, - 11.6 to 7.8%) for AVol and - 2.0 +/- 5.4% (95% LOA, - 12.5 to 8.6%) for TVol. Technical factors were related to image optimization, transducer pressure, fetal movement, soft tissue compression and amniotic fluid volume.ConclusionsFractional limb volume assessment may improve the detection and monitoring of malnourished fetuses because this soft tissue parameter can be obtained quickly and reproducibly during mid to late pregnancy. Careful attention should be placed on technical factors that can potentially affect optimal acquisition and analysis of these volume measurements.

Dataset Information

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

Publications

Technical and Regulatory Considerations for Taking Liquid Biopsy to the Clinic: Validation of the JAX PlasmaMonitor<sup>TM</sup> Assay.

Similar Datasets

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