Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Technology Enables Detection of Early-Stage Lung Cancer

October 9, 2018 By Elsevier

Non-small-cell lung carcinoma (NSCLC) is often fatal because most cases are not diagnosed until they are so advanced that surgical intervention is no longer possible. To improve outcomes researchers are developing a blood test to detect lung cancer earlier in the disease. A report in The Journal of Molecular Diagnostics describes a new technology, electric field-induced release and measurement (EFIRM) that is both highly sensitive and specific in detecting two epidermal growth factor receptor (EGFR) mutations associated with lung cancer in the blood of NSCLC patients with early-stage disease. This platform is relatively inexpensive and capable of high-throughput testing.

Despite advances in chemotherapy, five-year survival for patients diagnosed with unresectable NSCLC is less than 10 percent. The ability to diagnose NSCLC in stages 1 and 2, when surgical resection and potential cure are still possible, could significantly reduce the mortality from NSCLC worldwide. “The revolutionary EFIRM technology is the most exciting development in noninvasive liquid biopsy in recent years. The potential to detect early-stage lung cancer patients with an affordable blood or saliva test could save thousands to tens of thousands of lives annually worldwide,” stated Charles M. Strom, MD, PhD, co-director of the Center for Oral/Head and Neck Oncology Research at the UCLA School of Dentistry, Los Angeles, CA, USA, and Senior Vice President and Chief Medical Officer of EZLife Bio, USA, Woodland Hills, CA, USA. The EFIRM technology can also be used to monitor treatment and detect recurrence in patients already diagnosed with NSCLC.

Previously, the investigators had successfully measured two actionable EGFR mutations (p.L858R and Exon 19del) in blood samples from patients with late-stage NSCLC using EFIRM technology. In the current study, they investigated whether the mutations could be found in samples from patients with early-stage disease.

The researchers collected plasma samples from 248 patients with radiographically-determined pulmonary nodules. Of those, 44 were diagnosed with Stage I or Stage II NSCLC (23 with biopsy-proven benign pulmonary nodules and 21 with Stage I or Stage II adenocarcinoma). EFIRM was able to detect the p.L858R mutation in 11 of 12 samples and the Exon 19del mutation in seven of nine samples, resulting in greater than 90 percent sensitivity and 80 percent specificity.

“Currently, the clinical sensitivity of EFIRM to detect patients with NSCLC is limited by the percentage of tumors containing either or both of the two variants, which is estimated at 27 percent of NSCLC tumors,” explained co-investigator Wu-Chou Su, MD, of the Department of Internal Medicine, National Cheng Kung University Hospital and College of Medicine of the National Cheng Kung University, Tainan, Taiwan. “We are presently developing a 10-variant panel that contains detecting mutations expressed in 50 percent of all lung malignancies.”

Investigators emphasize that this study does not present direct evidence that detecting EGFR mutations in the plasma of an individual is predictive that the patient has cancer. Future work will explore whether finding an EGFR mutation in the circulation has any predictive value. Currently, the EFIRM liquid biopsy may be helpful for guiding treatment selection in patients for whom biopsy material is not available.

“We are gratified by the performance of the EFIRM platform in patients whose tumors were still small enough to qualify for surgical care. Work is underway to increase the number of mutations analyzed and to automate the process to increase sensitivity and facilitate mass screening,” commented Dr. Strom.

The steps involved in the electric field-induced capture and release (EFIRM) assay are shown. Initially, allele-specific capture probes are immobilized in a conducting polymer gel at the base of each well in a 96 well plate. Subsequently, a small amount (20 to 30 ncl) of untreated saliva or plasma is added to hybridization fluid and added directly to the well (step 1). Subsequently an alternating electric current is applied causing allele-specific hybridization. In step 2, a biotinylated signal probe is added to each well and another electrically stimulated hybridization is performed. Finally, in step 3 a standard streptavidin/biotin/horse radish peroxidase (HRP) signal amplification is performed causing electrons to be drawn up through the gold electrode and the current in nanoamperes is measured by the EFRIM reader. Credit: Fang Wei, EZLife Bio

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech