Toward a Safer Blood Supply: The Impact of Molecular Testing

2013 ◽  
pp. 121-145
Author(s):  
Niel T. Constantine ◽  
Patricia A. Wright ◽  
Ahmed Saleh ◽  
Anna DeMarinis
Keyword(s):  
Blood Supply ◽  
Molecular Testing ◽  
The Impact

Incorporation of plasma-based next-generation sequencing to improve guideline-concordant molecular testing in patients with newly diagnosed metastatic nonsquamous non-small cell lung cancer.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 14-14
Author(s):  
Charu Aggarwal ◽  
Melina Elpi Marmarelis ◽  
Wei-Ting Hwang ◽  
Dylan G. Scholes ◽  
Aditi Puri Singh ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Practice Change ◽  
Molecular Testing ◽  
Tier 2 ◽  
Newly Diagnosed ◽  
Next Generation ◽  
First Line ◽  
Tier 1 ◽  
Tier 3 ◽  
The Impact

14 Background: Current NCCN guidelines recommend comprehensive molecular profiling for all newly diagnosed patients with metastatic non-squamous NSCLC to enable the delivery of personalized medicine. We have previously demonstrated that incorporation of plasma based next-generation gene sequencing (NGS) improves detection of clinically actionable mutations in patients with advanced NSCLC (Aggarwal et al, JAMA Oncology, 2018). To increase rates of comprehensive molecular testing at our institution, we adapted our clinical practice to include concurrent use of plasma (P) and tissue (T) based NGS upon initial diagnosis. P NGS testing was performed using a commercial 74 gene assay. We analyzed the impact of this practice change on guideline concordant molecular testing at our institution. Methods: A retrospective cohort study of patients with newly diagnosed metastatic non-squamous NSCLC following the implementation of this practice change in 12/2018 was performed. Tiers of NCCN guideline concordant testing were defined, Tier 1: complete EGFR, ALK, BRAF, ROS1, MET, RET, NTRK testing, Tier 2: included above, but with incomplete NTRK testing, Tier 3: > 2 genes tested, Tier 4: single gene testing, Tier 5: no testing. Proportion of patients with comprehensive molecular testing by modality (T NGS vs. T+P NGS) were compared using one-sided Fisher’s exact test. Results: Between 01/2019, and 12/2019, 170 patients with newly diagnosed metastatic non-Sq NSCLC were treated at our institution. Overall, 98.2% (167/170) patients underwent molecular testing, Tier 1: n = 100 (59%), Tier 2: n = 39 (23%), Tier 3/4: n = 28 (16.5%), Tier 5: n = 3 (2%). Amongst these patients, 43.1% (72/167) were tested with T NGS alone, 8% (15/167) with P NGS alone, and 47.9% (80/167) with T+P NGS. A higher proportion of patients underwent comprehensive molecular testing (Tiers 1+2) using T+P NGS: 95.7% (79/80) compared to T alone: 62.5% (45/72), p < 0.0005. Prior to the initiation of first line treatment, 72.4% (123/170) patients underwent molecular testing, Tier 1: n = 73 (59%), Tier 2: n = 27 (22%) and Tier 3/4: n = 23 (18%). Amongst these, 39% (48/123) were tested with T NGS alone, 7% (9/123) with P NGS alone and 53.6% (66/123) with T+P NGS. A higher proportion of patients underwent comprehensive molecular testing (Tiers 1+2) using T+P NGS, 100% (66/66) compared to 52% (25/48) with T NGS alone (p < 0.0005). Conclusions: Incorporation of concurrent T+P NGS testing in treatment naïve metastatic non-Sq NSCLC significantly increased the proportion of patients undergoing guideline concordant molecular testing, including prior to initiation of first-line therapy at our institution. Concurrent T+P NGS should be adopted into institutional pathways and routine clinical practice.

scholarly journals Determining the Seasonality of Respiratory Syncytial Virus in the United States: The Impact of Increased Molecular Testing

2017 ◽  
Vol 216 (3) ◽  
pp. 345-355 ◽  
Author(s):  
Claire M Midgley ◽  
Amber K Haynes ◽  
Jason L Baumgardner ◽  
Christina Chommanard ◽  
Sara W Demas ◽  
...  
Keyword(s):  
United States ◽  
Respiratory Syncytial Virus ◽  
The United States ◽  
Molecular Testing ◽  
Syncytial Virus ◽  
The Impact

scholarly journals Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Kira L. Newman ◽  
◽  
Julia H. Rogers ◽  
Denise McCulloch ◽  
Naomi Wilcox ◽  
...  
Keyword(s):  
Point Of Care ◽  
Antiviral Treatment ◽  
Homeless Shelters ◽  
Molecular Testing ◽  
Symptom Duration ◽  
Homeless Shelter ◽  
Stepped Wedge ◽  
Site Testing ◽  
Cluster Randomized ◽  
The Impact

Abstract Introduction Influenza is an important public health problem, but data on the impact of influenza among homeless shelter residents are limited. The primary aim of this study is to evaluate whether on-site testing and antiviral treatment of influenza in residents of homeless shelters reduces influenza spread in these settings. Methods and analysis This study is a stepped-wedge cluster-randomized trial of on-site testing and antiviral treatment for influenza in nine homeless shelter sites within the Seattle metropolitan area. Participants with acute respiratory illness (ARI), defined as two or more respiratory symptoms or new or worsening cough with onset in the prior 7 days, are eligible to enroll. Approximately 3200 individuals are estimated to participate from October to May across two influenza seasons. All sites will start enrollment in the control arm at the beginning of each season, with routine surveillance for ARI. Sites will be randomized at different timepoints to enter the intervention arm, with implementation of a test-and-treat strategy for individuals with two or fewer days of symptoms. Eligible individuals will be tested on-site with a point-of-care influenza test. If the influenza test is positive and symptom onset is within 48 h, participants will be administered antiviral treatment with baloxavir or oseltamivir depending upon age and comorbidities. Participants will complete a questionnaire on demographics and symptom duration and severity. The primary endpoint is the incidence of influenza in the intervention period compared to the control period, after adjusting for time trends. Trial registration ClinicalTrials.gov NCT04141917. Registered 28 October 2019. Trial sponsor: University of Washington.

scholarly journals 240. The Clinical Utility of Molecular Testing in the Diagnosis and Management of Infectious Diseases: Plasma-based Next-Generation Sequencing (PNGS)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S136-S136
Author(s):  
Jim H Nomura ◽  
Townson Tsai
Keyword(s):  
Fungal Infections ◽  
Retrospective Chart Review ◽  
Blood Cultures ◽  
Common Reason ◽  
Clinical Indication ◽  
Molecular Diagnostic ◽  
Cns Infection ◽  
Molecular Testing ◽  
Disseminated Disease ◽  
The Impact

Abstract Background Molecular diagnostic tests can provide microbiologic results rapidly and with greater sensitivity than traditional methods. However, these tests come with considerable costs, so thoughtful diagnostic stewardship is essential to ensure that resources and outcomes are optimized. We sought to evaluate the impact of PNGS testing on patient management. Methods From February 2017 to January 2019, physicians in our group ordered 164 PNGS tests (Karius, Redwood City CA) on 125 patients. A retrospective chart review was performed to determine the clinical indication and utility of the test. Results The assay failure rate was 4.9% (8/164). Positive (pos) results were noted in 34% (53/156), of which 23 (43.4%) represented false pos results; 28 were true pos (52.8%) but 2 were unnecessary (also had pos blood cultures). The most common reason for testing was to assess for Mycobacterium chimera (Mc) infection, representing 94 of 156 (60.3%) tests. Of the 21 patients with known Mc, only 10/21 had pos initial tests (47.6%); if patients with Mc localized to the sternum were excluded (8 patients), 76.9% with deep organ involvement had pos initial tests. Five patients with deep Mc infection had persistently pos results while on therapy; 4 of these had not had surgery; 1 was 6 months s/p valve replacement for Mc. The next most common indication was to r/o endocarditis in 18/156 (11.5%) and had an impact in 8/18 (44.4%), including 4 patients whose PNGS result identified a likely pathogen in culture negative endocarditis (CNE). Of the 62 tests done for non-Mc patients, 33.9% (21/62) were useful for management decisions. Among patients who eventually had a diagnosis made but had negative PNGS results included patients with Whipple’s (1), CNS infection (2), and fungal infections (5). Conclusion Overall, only 17.9% (28/156) of tests yielded true pos results. The most common reason was to evaluate for Mc infection. PNGS did not detect Mc in patients with proven local disease and was pos in >75% with deep/disseminated disease. However, a negative result did not exclude significant Mc infection. Repeat testing can be considered if clinical suspicion is high but should not be done before standard blood cultures are negative. While more than 60% of the non-Mc tests were not clinically useful, there was modest added utility where infection is high on the differential especially patients with CNE. Disclosures All authors: No reported disclosures.

Blunted peripheral blood supply and underdeveloped skeletal muscle in Fontan patients: The impact on functional capacity

2018 ◽  
Vol 271 ◽  
pp. 54-59 ◽  
Author(s):  
Aida Luiza Ribeiro Turquetto ◽  
Marcelo Rodrigues dos Santos ◽  
Ana Luiza Carrari Sayegh ◽  
Francis Ribeiro de Souza ◽  
Daniela Regina Agostinho ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Blood Supply ◽  
Functional Capacity ◽  
Peripheral Blood ◽  
The Impact ◽  
Fontan Patients

scholarly journals Evaluation of Omics-Based Strategies for the Management of Advanced Lung Cancer

2020 ◽  
pp. OP.20.00117
Author(s):  
Ravi Salgia ◽  
Isa Mambetsariev ◽  
Rebecca Pharaon ◽  
Jeremy Fricke ◽  
Angel Ray Baroz ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Decision Making ◽  
Targeted Therapy ◽  
Predictive Value ◽  
Advanced Nsclc ◽  
Therapeutic Options ◽  
Advanced Lung Cancer ◽  
Molecular Testing ◽  
Cox Regression Analysis ◽  
The Impact

PURPOSE: Omic-informed therapy is being used more frequently for patients with non–small-cell lung cancer (NSCLC) being treated on the basis of evidence-based decision-making. However, there is a lack of a standardized framework to evaluate those decisions and understand the association between omics-based management strategies and survival among patients. Therefore, we compared outcomes between patients with lung adenocarcinoma who received omics-driven targeted therapy versus patients who received standard therapeutic options. PATIENTS AND METHODS: This was a retrospective study of patients with advanced NSCLC adenocarcinoma (N = 798) at City of Hope who received genomic sequencing at the behest of their treating oncologists. A thoracic oncology registry was used as a clinicogenomic database to track patient outcomes. RESULTS: Of 798 individuals with advanced NSCLC (median age, 65 years [range, 22-99 years]; 60% white; 50% with a history of smoking), 662 patients (83%) had molecular testing and 439 (55%) received targeted therapy on the basis of the omic-data. A fast-and-frugal decision tree (FFT) model was developed to evaluate the impact of omics-based strategy on decision-making, progression-free survival (PFS), and overall survival (OS). We calculated that the overall positive predictive value of the entire FFT strategy for predicting decisions regarding the use of tyrosine kinase inhibitor–based targeted therapy was 88% and the negative predictive value was 96%. In an adjusted Cox regression analysis, there was a significant correlation with survival benefit with the FFT omics-driven therapeutic strategy for both PFS (hazard ratio [HR], 0.56; 95% CI, 0.42 to 0.74; P < .001) and OS (HR, 0.51; 95% CI, 0.36 to 0.71; P < .001) as compared with standard therapeutic options. CONCLUSION: Among patients with advanced NSCLC who received care in the academic oncology setting, omics-driven therapy decisions directly informed treatment in patients and was correlated with better OS and PFS.

The Impact of Direct Cash Payments on Whole Blood Supply

2019 ◽  
Vol 20 (4) ◽  
pp. e973-e1001 ◽  
Author(s):  
David M. Becker ◽  
Harald Klüter ◽  
Alexandra Niessen-Ruenzi ◽  
Martin Weber
Keyword(s):  
Blood Supply ◽  
Whole Blood ◽  
Blood Donation ◽  
Monetary Incentives ◽  
Payment Scheme ◽  
Monetary Compensation ◽  
Payment Schemes ◽  
The Impact ◽  
Insight Into ◽  
Complex Question

Abstract This paper investigates the impact of monetary incentives on whole blood donations. We take advantage of a quasi-natural experiment in Germany, in which one blood donation site changes its payment scheme from remunerated to non-remunerated. All other donation sites maintain their payment schemes. We show that donation volumes drop significantly after the pay drop and do not recuperate. At the same time, donation volumes increase at other paid donation sites, which is partly due to donor migration to these sites. We do not find any impact of the changed payment scheme on blood quality. Our results offer additional insight into the complex question whether it is efficient to ensure blood supply by paying donors a direct monetary compensation.

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