FoundationOne®CDx (F1CDx) is a United States (US) Food and Drug Administration (FDA)-approved companion diagnostic test to identify patients who may benefit from treatment in accordance with the approved therapeutic product labeling for 28 drug therapies. F1CDx utilizes next-generation sequencing (NGS)-based comprehensive genomic profiling (CGP) technology to examine 324 cancer genes in solid tumors. F1CDx reports known and likely pathogenic short variants (SVs), copy number alterations (CNAs), and select rearrangements, as well as complex biomarkers including tumor mutational burden (TMB) and microsatellite instability (MSI), in addition to genomic loss of heterozygosity (gLOH) in ovarian cancer. CGP services can reduce the complexity of biomarker testing, enabling precision medicine to improve treatment decision-making and outcomes for cancer patients, but only if test results are reliable, accurate, and validated clinically and analytically to the highest standard available. The analyses presented herein demonstrate the extensive analytical and clinical validation supporting the F1CDx initial and subsequent FDA approvals to ensure high sensitivity, specificity, and reliability of the data reported. The analytical validation included several in-depth evaluations of F1CDx assay performance including limit of detection (LoD), limit of blank (LoB), precision, and orthogonal concordance for SVs (including base substitutions [SUBs] and insertions/deletions [INDELs]), CNAs (including amplifications and homozygous deletions), genomic rearrangements, and select complex biomarkers. The assay validation of >30,000 test results comprises a considerable and increasing body of evidence that supports the clinical utility of F1CDx to match patients with solid tumors to targeted therapies or immunotherapies based on their tumor’s genomic alterations and biomarkers. F1CDx meets the clinical needs of providers and patients to receive guideline-based biomarker testing, helping them keep pace with a rapidly evolving field of medicine.

/pdf/clinical-and-analytical-validation-of-foundationone-r-cdx-a-121fa9q2.pdf

Clinical and analytical validation of FoundationOne®CDx, a comprehensive genomic profiling assay for solid tumors

Rural cancer patients have less access to cancer clinical trials than those living in urban areas. This is one of many existing inequities that needs addressing to improve cancer outcomes for rural residents. Given the paucity of literature on the participation of rural residents in cancer clinical trials, we conducted a scoping review to investigate three primary research questions: (1) What is the participation rate of rural cancer patients in clinical trials? (2) What are the barriers and enablers to participation? (3) What initiatives facilitate participation of rural cancer patients in clinical trials?

Barriers and enablers to cancer clinical trial participation and initiatives to improve opportunities for rural cancer patients: A scoping review

Empiric selection of drugs has a low rate of success in cancer patients whose treatment options are limited due to previous treatments or have rare cancer types with no standard effective treatment options. Guidance based on the molecular characteristics of the tumour can provide valuable insights for the physician as to which treatments could be beneficial and, conversely, which would be best to avoid. With the advent of rapid, affordable tumour-profiling technologies, many serviEces have been launched which offer patients and physicians this information. However, the field remains relatively unregulated and few services to date have demonstrated that their approach has meaningful clinical utility or clinical benefit with an acceptable cost-effectiveness ratio. In this review, we describe the concept and clinical data supporting the use of one such service, Caris Molecular Intelligence (CMI). Caris have been pioneers in the field of precision medicine for over a decade. Over 120,000 clinical publications describing the predictive nature of biomarkers were reviewed and graded to provide the basis for proprietary software that matches the published evidence with the test results from a multiplatform approach that measures proteins, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA).The CMI results help physicians to select drugs that are more likely to benefit anindividual patient, avoid those drugs that are not likely to work, and provide treatment options that otherwise would not be considered. Globally, over 85,000 patients with over 150 different types of cancer have been profiled with CMI. The Caris approach has shown to be effective in 10 physician-led evaluations, and the results of a prospective observational registry show a significant overall survival benefit in patients treated in line with the report. In over 350 patients treated as part of a CMI evaluation, 75% have been treated based on the report and over 40% of those evaluable had clinical benefit. These outcomes help to illustrate the clinical utility of this approach in helping patients where the next treatment decision is difficult.

https://www.graphyonline.com/archives/IJSSP/2016/IJSSP-107/article.pdf

Multi-platform Tumour Profiling Delivers the Highest Clinical Utility and Improves Patient Outcomes in Today's Routine Clinical Practice

Molecular Tumour Boards (MTBs) were created with the purpose of supporting clinical decision making within precision medicine. Though these meetings are in use globally reporting often focuses on the small percentages of patients that receive treatment via this process and are less likely to report on, and assess, patients who do not receive treatment. A literature review was performed to understand patient attrition within MTBs and barriers to patients receiving treatment. A total of 56 papers were reviewed spanning a 6 year period from 11 different countries. 20% of patients received treatment through the MTB process. Of those that did not receive treatment the main reasons were no mutations identified (26%), no actionable mutations (22%) and clinical deterioration (15%). However, the data was often incomplete due to inconsistent reporting of MTBs with only 54% reporting on patients having no mutations, 48% reporting on presence of actionable mutations and 57% reporting on clinical deterioration. Patient attrition in MTBs is an issue which is very rarely alluded to in reporting, more transparent reporting is needed to understand barriers to treatment and integration of new technologies is required to process increasing omic and treatment data.

/pdf/patient-attrition-in-molecular-tumour-boards-a-review-3xe0wa6gx5.pdf

Patient attrition in Molecular Tumour Boards: A Review

Interpretation of Reports and Translation to Community Oncologists: An Overview of Approaches

IntroductionPrecision oncology (PO) is a growing treatment approach in the era of next-generation sequencing (NGS) and matched therapies. Effective delivery of PO in the community has not been extensively studied. Our program developed a virtual molecular tumor board (MTB) strategy to help guide PO care.Materials and MethodsOver 18 months, eligible adult patients with advanced, incurable solid tumor malignancies were enrolled in a molecular profiling (MP) study using the Foundation Medicine NGS panel. Results were reviewed through a weekly, videoconferenced MTB conducted across our largely rural integrated health system. Recommendations from the MTB were used to identify actionable alterations (AAs). Feasibility of PO care delivery was assessed as the primary outcome. Secondary outcomes included the frequency of AAs, genomic matched treatments, genomic matched clinical trial enrollment, and clinical outcomes.ResultsA total of 120 participants with a variety of advanced tumor types were enrolled. Of these,...

Delivering Precision Oncology in a Community Cancer Program: Results From a Prospective Observational Study

e18036Background: While molecular profiling (MP) is becoming widely accessible, clinician understanding may be a barrier to GMCT enrollment. MP programs at academic medical centers report GMCT enro...

Optimizing Genotype Matched Clinical Trial (GMCT) accrual in a community oncology program (COP).

Handle everyday research tasks with reliable, citation-backed results

Your personal Research Agent to handle research tasks with citation-backed results

Popular Tasks used by Researchers

How can I help with your research?

Meet SciSpace

Get more enhanced response by uploading the PDFs you want me to reference.

No relevant PDFs in your library

SciSpace is the AI research assistant for academics. Run systematic literature reviews on 280M+ papers, and write papers with cited sources. Trusted by 1M+ students, PhDs & researchers.

SciSpace | AI for Research

Analyze PDFs

Code & Manuscripts

Funding & Grants

Literature & Patents

Medical & Clinical Data

Systematic Review

Visualize & Present

Web & Data

Build a Google Scholar-like website for your research.

Build a website

Create charts and images for your research

Create a Chart

Write a paper for submission to a journal

Draft a manuscript

Patent Search

Design eye-catching scientific posters in minutes.

Scientific Poster Generation

Systematic Literature Review

One task is running at the moment. Your messages will be shown right after.

Drag and drop or click here to browse

Loved by <highlight>1 million+</highlight> researchers

Extract a list of specific topics and their sources from unstructured text

Topics

Compare and analyze relevant papers that matches with your search

Papers

Get insights from PDFs and bookmarked papers from your library

My library

Recent searches

Try searching for:

Catch AI-generated content in scholarly and non-scholarly content

{ai} Detector

Ai Writer

Get PDF Summaries, highlighted text explanations 

Chat with PDF

Effortlessly create in-text citations and bibliographies in APA and 2,500 other formats

Citation generator

Get explanations, summaries, and answers on academic papers

Ease up your research workflow with {scispace}'s cohort of exciting AI tools

Elevate your academic writing skills and convey your ideas the way you want

Paraphraser

Explore our range of reading and writing tools

Your file is being prepared and should be ready in a few minutes. If it's a large file, it might take a bit longer. You can close this window, and we'll email you the file when it's done.

You have reached a maximum limit of <strong>{limit}</strong> columns in the table. Remove at least <strong>1</strong> column to add or create another one.

Michael D. Keppen

Author Tools

Chat about Author

Papers

Delivering Precision Oncology in a Community Cancer Program: Results From a Prospective Observational Study

Optimizing Genotype Matched Clinical Trial (GMCT) accrual in a community oncology program (COP).