Precision medicine initiative boosts funding for NCI efforts: Proposal would help broaden availability of targeted therapies

Cancer ◽  
2015 ◽  
Vol 121 (19) ◽  
pp. 3369-3370 ◽  
Author(s):  
Carrie Printz
Keyword(s):  
Precision Medicine ◽  
Targeted Therapies ◽  
Precision Medicine Initiative

scholarly journals A Survey of U.S Adults’ Opinions about Conduct of a Nationwide Precision Medicine Initiative® Cohort Study of Genes and Environment

PLoS ONE ◽  
2016 ◽  
Vol 11 (8) ◽  
pp. e0160461 ◽  
Author(s):  
David J. Kaufman ◽  
Rebecca Baker ◽  
Lauren C. Milner ◽  
Stephanie Devaney ◽  
Kathy L. Hudson
Keyword(s):  
Cohort Study ◽  
Precision Medicine ◽  
Genes And Environment ◽  
Precision Medicine Initiative

scholarly journals Pathogenic mutations and overall survival in 3,084 patients with cancer: the Hellenic Cooperative Oncology Group Precision Medicine Initiative

Oncotarget ◽  
2020 ◽  
Vol 11 (1) ◽  
pp. 1-14
Author(s):  
Elena Fountzilas ◽  
Vassiliki Kotoula ◽  
Georgia-Angeliki Koliou ◽  
Eleni Giannoulatou ◽  
Helen Gogas ◽  
...  
Keyword(s):  
Overall Survival ◽  
Precision Medicine ◽  
Oncology Group ◽  
Patients With Cancer ◽  
Pathogenic Mutations ◽  
Precision Medicine Initiative

Precision medicine: beyond genomics to targeted therapies

2016 ◽  
Vol 13 (2) ◽  
pp. 97-100
Author(s):  
Ralph Snyderman ◽  
David Spellmeyer
Keyword(s):  
Precision Medicine ◽  
Targeted Therapies

Impact of rapid multigene assays with short turnaround time (TAT) on the development of precision medicine for non-small cell lung cancer (NSCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9094-9094
Author(s):  
Shingo Matsumoto ◽  
Takaya Ikeda ◽  
Kiyotaka Yoh ◽  
Akira Sugimoto ◽  
Terufumi Kato ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Precision Medicine ◽  
Targeted Therapies ◽  
Advanced Nsclc ◽  
Genetic Alterations ◽  
Braf V600e ◽  
Gene Testing ◽  
Genomic Screening ◽  
Nsclc Patients

9094 Background: A variety of oncogene drivers have been identified in NSCLC and molecularly-stratified precision medicine has led to improved survival in advanced NSCLC. Next-generation sequencing (NGS)-based testing is utilized to detect actionable gene alterations; however, the TAT of NGS is often too long to translate into clinical decision making. Thus, rapid multi-gene testing alternatives are needed. Methods: A lung cancer genomic screening project (LC-SCRUM-Asia) capturing clinical outcome was established in 2013 to identify patients with oncogene drivers and to support the development of novel targeted therapies. Since February 2013 to May 2019 (LC-SCRUM-Asia 1st-phase), single gene testing and/or a targeted NGS assay, Oncomine Comprehensive Assay (OCA), were used for the genomic screening. Since June 2019 to December 2020 (2nd-phase), a multi-gene PCR assay (Amoy 9-in-1 test) and a rapid NGS assay (Genexus/Oncomine Precision Assay [OPA]) were also implemented as rapid multi-gene testing. Results: A total of 10667 Japanese NSCLC patients, including 6826 in the 1st-phase and 3841 in the 2nd-phase, were enrolled in the LC-SCRUM-Asia. Success rate for OCA: 93%, for 9-in-1 test: 98%, for Genexus/OPA: 96%. Median TAT for OCA: 21 days, for 9-in-1 test: 3 days, for Genexus/OPA: 4 days. The frequencies of genetic alterations detected in the 1st-/2nd-phase were EGFR: 17/24%, KRAS: 15/16%, HER2 ex20ins: 4/3%, ALK fusions: 3/3%, RET fusions: 3/2%, ROS1 fusions: 3/2%, MET ex14skip: 2/2%, BRAF V600E: 1/1%, NRG1 fusions: 0/0.2% and NTRK3 fusions: 0.05/0.04%. Overall percent agreement of 9-in-1 test compared with OCA for EGFR/KRAS/HER2/BRAF/MET/ALK/ROS1/RET/NTRK3 alterations was 98%, and that of OPA compared with OCA was 95%. The rate of patients who received targeted therapies as 1st-line treatment was significantly elevated in the 2nd-phase compared with the 1st-phase (510/3841 [13%] vs. 567/6826 [8%], p < 0.001). Through the genomic screening, 1410 (37%) and 1269 (18%) candidate patients for clinical trials of KRAS, HER2, BRAF, MET, ALK, ROS1, RET or TRK-targeted drugs were identified in the 2nd-phase and in the 1st-phase, respectively. The rate of patients who were actually enrolled into the genotype-matched clinical trials were also significantly higher in the 2nd-phase than in the 1st-phase (222 [6%] vs. 186 [3%], p < 0.001). In 1st-line treatments for advanced NSCLC patients, the median progression-free survival was 8.5 months (95% CI, 7.7−9.4) in the 2nd-phase (n = 1839) versus 6.1 months (95% CI, 5.9−6.3) in the 1st-phase (n = 4262) (p < 0.001). Conclusions: Both the 9-in-1 test and Genexus/OPA had short TATs (3−4 days), high success rates (96−98%) and good concordance (95−98%) compared with another NGS assay (OCA). These rapid multi-gene assays highly contributed to enabling precision medicine and the development of targeted therapies for advanced NSCLC.

Individualized dosing of oral targeted therapies in oncology is crucial in the era of precision medicine

2019 ◽  
Vol 75 (9) ◽  
pp. 1309-1318 ◽  
Author(s):  
Stefanie L. Groenland ◽  
Ron H. J. Mathijssen ◽  
Jos H. Beijnen ◽  
Alwin D. R. Huitema ◽  
Neeltje Steeghs
Keyword(s):  
Precision Medicine ◽  
Targeted Therapies ◽  
Individualized Dosing

scholarly journals Two Threats to Precision Medicine Equity

2019 ◽  
Vol 29 (Supp) ◽  
pp. 629-640
Author(s):  
Dayna Bowen Matthew
Keyword(s):  
United States ◽  
Precision Medicine ◽  
Care Delivery ◽  
Research Effort ◽  
The United States ◽  
Medical Product ◽  
Great Promise ◽  
Sequencing Technologies ◽  
Legal Duty ◽  
Precision Medicine Initiative

In January 2015, President Barack Obama unveiled the “Precision Medicine Initiative,” a nationwide research effort to help bring an effective, preventive, and therapeutic approach to medicine. The purpose of the initiative is to bring a precise understanding of the genetic and environmental determi­nants of disease into clinical settings across the United States.1 The announcement was coupled with $216 million provided in the President’s proposed budget for a million-person national research cohort including public and private partnerships with academic medical centers, research­ers, foundations, privacy experts, medical ethicists, and medical product innovators. The Initiative promises to expand the use of precision medicine in cancer research and modernize regulatory approval processes for genome sequencing technologies. In response, Congress passed the 21st Century Cures Act in December 2016, authorizing a total of $1.5 billion over 10 years for the program.2 Although the Precision Medicine Initiative heralds great promise for the future of disease treatment and eradication, its implementation and development must be carefully guided to ensure that the millions of federal dollars expended will be spent equitably. This commentary discusses two key threats to the Precision Medicine Initia­tive’s ability to proceed in a manner consis­tent with the United States Constitutional requirement that the federal government shall not “deny to any person . . . the equal protection of the laws.”3 In short, this com­mentary sounds two cautionary notes, in order to advance precision medicine equity. First, achieving precision medicine equity will require scientists and clinicians to fulfill their intellectual, moral, and indeed legal duty to work against abusive uses of preci­sion medicine science to advance distorted views of racial group variation.Precision medicine scientists must decisively denounce and distinguish this Initiative from the pseudo-science of eugenics – the im­moral and deadly pseudo-science that gave racist and nationalist ideologies what Troy Duster called a “halo of legitimacy” during the first half of the 20th century.4 Second, to combat the social threat to precision medicine, scientists must incorporate a comprehensive, ecological understanding of the fundamental social and environ­mental determinants of health outcomes in all research. Only then will the Precision Medicine Initiative live up to its potential to improve and indeed transform health care delivery for all patients, regardless of race, color, or national origin.Ethn Dis: 2019;29(Suppl 3):629-640; doi:10.18865/ed.29.S3.629

scholarly journals The Need for a Privacy Standard for Medical Devices That Transmit Protected Health Information Used in the Precision Medicine Initiative for Diabetes and Other Diseases

2016 ◽  
Vol 11 (2) ◽  
pp. 220-223 ◽  
Author(s):  
David C. Klonoff ◽  
W. Nicholson Price
Keyword(s):  
Precision Medicine ◽  
Medical Devices ◽  
Personal Information ◽  
Sensor Data ◽  
Willingness To Participate ◽  
Genomic Information ◽  
The Public ◽  
Important Concern ◽  
Privacy Standard ◽  
Precision Medicine Initiative

Privacy is an important concern for the Precision Medicine Initiative (PMI) because success of this initiative will require the public to be willing to participate by contributing large amounts of genetic/genomic information and sensor data. This sensitive personal information is intended to be used only for specified research purposes. Public willingness to participate will depend on the public’s level of trust that their information will be protected and kept private. Medical devices may constantly provide information. Therefore, assuring privacy for device-generated information may be essential for broad participation in the PMI. Privacy standards for devices should be an important early step in the development of the PMI.

Clinical and Germline Molecular Findings From an Ovarian Cancer Precision Medicine Initiative

2020 ◽  
Vol 158 (1) ◽  
pp. e16
Author(s):  
Z. Chang ◽  
W. Lee ◽  
Z.T. Rivers ◽  
L.D. Uppendahl ◽  
A. Grad ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Precision Medicine ◽  
Precision Medicine Initiative
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