We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
LGC Clinical Diagnostics

Download Mobile App




Events

09 Apr 2024 - 12 Apr 2024
15 Apr 2024 - 17 Apr 2024
23 Apr 2024 - 26 Apr 2024

Sequencing Assay Adopted for Advanced Lung Cancer Reflex Testing

By LabMedica International staff writers
Posted on 31 Dec 2018
Print article
Image: The Oncomine Focus Assay is performed using the Ion Torrent technology. The test is designed to help oncologists expedite selection of a treatment plan for their patients in days instead of weeks (Photo courtesy of Thermo Fisher Scientific).
Image: The Oncomine Focus Assay is performed using the Ion Torrent technology. The test is designed to help oncologists expedite selection of a treatment plan for their patients in days instead of weeks (Photo courtesy of Thermo Fisher Scientific).
Guidelines are rapidly moving toward upfront profiling with next-generation sequencing (NGS) of all advanced lung cancers, but there are still practical issues with this testing method that can limit clinical testing and prevent or delay patients being started on targeted therapies.

The growing number of genomically targeted therapies has made genomic testing an important part of the care for patients with non-small cell lung cancer. However, limited tissue availability, cost and long turnaround times can create barriers to efficient genomic testing and subsequent treatment. Effective approaches to reduce these barriers are needed.

A team of scientists collaborating with the University Hospitals Cleveland Medical Center (Cleveland, OH, USA) tested 302 advanced lung adenocarcinomas from consecutive patients using a hybrid DNA/RNA NGS panel. Sample testing was reflexed from pathology for all stage III or IV tumors. Genomic alterations were tiered according to their clinical relevance and reported with guideline-recommended therapies.

The investigators used the Oncomine Focus Assay, which is an NGS oncology assay designed to simultaneously analyze hundreds of variants across 52 genes relevant to solid tumors. The assay enables concurrent analysis of DNA and RNA in a single workflow to detect hot spots, single nucleotide variants, indels, copy number variants, and gene fusions in various types of solid tumors. The clinicians validated the assay for use at the UHCMC CLIA-certified translational laboratory and expanded it to include 17 new biomarkers.

With a sample cohort consisting of 64% biopsies, 16% excisions/resections and 20% fine needle aspirations, the assay was reliable with a 95% success rate. The average turnaround time from receipt of unstained formalin-fixed paraffin embedded slides to reporting was 4.8±2.1 days, half of the recommended 10 days and similar to single-gene testing. Through testing, the clinicians found alterations associated with Food and Drug Administration-approved or the National Cancer Center Network (NCCN) guideline-recommended targeted therapies in 18% of cases, and they sent 60% of those patients for genomically guided therapies.

Joydeep Goswami, PhD, MBA, president of clinical next-generation sequencing and oncology for Thermo Fisher Scientific, said, “Perhaps the most important finding in this study is the ability to identify a much broader set of relevant targets in half the time recommended by NCCN guidelines, without increasing cost to the hospital. Single assay, multibiomarker tests with low tissue sample requirements allow more patients to access targeted therapies and lead to significantly higher test success rates, while simultaneously reducing total cost of care.” The study was published in the December 2018 issue of the Journal of Clinical Pathology.

Related Links:
University Hospitals Cleveland Medical Center

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Systemic Autoimmune Testing Assay
BioPlex 2200 ANA Screen with MDSS

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria (Photo courtesy of Roche)

First FDA-Approved Molecular Test to Screen Blood Donors for Malaria Could Improve Patient Safety

Malaria, a serious illness that often leads to death, is spread by a specific mosquito species that infect humans with a parasite. Other transmission modes include blood transfusions, organ transplants,... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.