Conexiant
Login
  • The Analytical Scientist
  • The Cannabis Scientist
  • The Medicine Maker
  • The Ophthalmologist
  • The Pathologist
  • The Traditional Scientist
The Pathologist
  • Explore Pathology

    Explore

    • Latest
    • Insights
    • Case Studies
    • Opinion & Personal Narratives
    • Research & Innovations
    • Product Profiles

    Featured Topics

    • Molecular Pathology
    • Infectious Disease
    • Digital Pathology

    Issues

    • Latest Issue
    • Archive
  • Subspecialties
    • Oncology
    • Histology
    • Cytology
    • Hematology
    • Endocrinology
    • Neurology
    • Microbiology & Immunology
    • Forensics
    • Pathologists' Assistants
  • Training & Education

    Career Development

    • Professional Development
    • Career Pathways
    • Workforce Trends

    Educational Resources

    • Guidelines & Recommendations
    • App Notes

    Events

    • Webinars
    • Live Events
  • Events
    • Live Events
    • Webinars
  • Profiles & Community

    People & Profiles

    • Power List
    • Voices in the Community
    • Authors & Contributors
  • Multimedia
    • Video
    • Podcasts
Subscribe
Subscribe

False

The Pathologist / Issues / 2016 / Jun / Liquid License
Oncology Liquid biopsy Companion diagnostics Precision medicine Regulation and standards Oncology Genetics and epigenetics Screening and monitoring Omics

Liquid License

FDA issues first-ever approval for liquid biopsy companion diagnostic

By Michael Schubert 06/23/2016 1 min read

Share

Lung cancer is the leading cause of cancer deaths among both men and women, and with non-small cell lung cancer (NSCLC) being the most common type, it’s no surprise that plenty of attention is focused on finding ways to treat it. In particular, tailoring treatment and diagnosis has been a key aim of most researchers active in the field and one major step forward in this regard has been in the development of the drug erlotinib, which inhibits the epidermal growth factor receptor (EGFR) and has proven to be maximally effective in NSCLC patients with EGFR gene mutations. As with many mutation-targeting therapeutics, the hunt for an effective accompanying diagnostic has been ongoing, and one such test has proven itself worthy of a Food and Drug Administration (FDA) seal of approval – the first diagnostic of its kind to get the nod from the US regulators.

Noninvasive, blood-based tests, or liquid biopsies as they are commonly known, have garnered a lot of attention recently, in particular because of their noninvasive nature. These tests involve detecting DNA shed by tumors into patients’ blood, allowing tumor DNA to be sequenced and examined without the need for an invasive and potentially risky tissue biopsy. Until recently, such tests were in their experimental stages, but as of June 1st, the FDA issued its first-ever approval for a liquid biopsy test (1). The cobas EGFR Mutation Test v2 is a companion diagnostic to erlotinib, which is FDA-approved for first-line treatment in patients with specific EGFR mutations (either an exon 19 deletion or an L858R substitution). Although NSCLC accounts for over 1.5 million cancer diagnoses per year worldwide (2), this test approval is just the first step on a long road. If the trend continues, we may soon see liquid biopsies designed to detect mutations in a wide range of cancers, helping medical professionals personalize each patient’s treatment based on their tumor’s genetic profile – all without the need for tissue sampling.

Newsletters

Receive the latest pathology news, personalities, education, and career development – weekly to your inbox.

Newsletter Signup Image

References

  1. FDA, “FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer”, (2016). Available at: http://1.usa.gov/1Uvkn3N. Accessed June 13, 2016. Cancer Research UK, “Lung cancer incidence statistics” (2013). Available at: http://bit.ly/1U46ozN. Accessed June 13, 2016.

About the Author(s)

Michael Schubert

While obtaining degrees in biology from the University of Alberta and biochemistry from Penn State College of Medicine, I worked as a freelance science and medical writer. I was able to hone my skills in research, presentation and scientific writing by assembling grants and journal articles, speaking at international conferences, and consulting on topics ranging from medical education to comic book science. As much as I’ve enjoyed designing new bacteria and plausible superheroes, though, I’m more pleased than ever to be at Texere, using my writing and editing skills to create great content for a professional audience.

More Articles by Michael Schubert

Explore More in Pathology

Dive deeper into the world of pathology. Explore the latest articles, case studies, expert insights, and groundbreaking research.

False

Advertisement

Recommended

False

Related Content

A Light in the Darkness
Liquid biopsy
A Light in the Darkness

March 4, 2022

2 min read

Spectroscopic liquid biopsy testing – a new route to brain cancer diagnostics

Biomarkers: The Bigger Picture
Liquid biopsy
Biomarkers: The Bigger Picture

April 27, 2022

1 min read

To unlock patient care, pathologists must focus on molecular pathology and ensure efficiency and effectiveness to improve testing. With this testing, patients can benefit from the best treatment to combat their disease.

Benchmarking… Liquid Biopsy
Liquid biopsy
Benchmarking… Liquid Biopsy

May 13, 2022

1 min read

A look at the last five years of publishing on liquid biopsy

Does Your Blood Know You Have Cancer?
Liquid biopsy
Does Your Blood Know You Have Cancer?

July 25, 2022

2 min read

Detection and monitoring are crucial for melanoma outcomes – could a blood test revolutionize both?

False

The Pathologist
Subscribe

About

  • About Us
  • Work at Conexiant Europe
  • Terms and Conditions
  • Privacy Policy
  • Advertise With Us
  • Contact Us

Copyright © 2025 Texere Publishing Limited (trading as Conexiant), with registered number 08113419 whose registered office is at Booths No. 1, Booths Park, Chelford Road, Knutsford, England, WA16 8GS.