CACLP - The largest IVD Expo & Conference CACLP - The largest IVD Expo & Conference CACLP - The largest IVD Expo & Conference @CACLP
CACLP - The largest IVD Expo & Conference
CACLP - The largest IVD Expo & Conference
中
Visitor registration Book your stand
CACLP - The largest IVD Expo & Conference

FDA Approves Roche Cobas EGFR Mutation Test as CDx for Iress

Industry news | 30 August, 2018 | CACLP
Roche said recently that the US Food and Drug Administration has approved its Cobas EGFR Mutation Test v2 as a companion diagnostic test with AstraZeneca's cancer drug Iressa (gefitinib) for first-line treatment of patients with non-small cell lung cancer.
 
The approval includes the use of either tumor tissue or plasma. It follows previous approvals of the test as a CDx with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
 
The Cobas EGFR Mutation Test v2 is a real-time PCR test that detects 42 mutations in the EGFR gene in exons 18 to 21, including L858R, exon 19 deletions, and T790M mutations. It runs on Roche's Cobas 4800 system. Roche pointed out that the test is currently the only FDA-approved diagnostic for NSCLC that can use both tissue and liquid biopsy patient samples.
Filed under：
FDA
Press contact CACLP - The largest IVD Expo & Conference
Back to list

Most popular

ChatGPT outperformed doctors in diagnostic accuracy, study reveals

ARC and Roche collaborate to enhance NSCLC diagnostics using AI

NMPA Delegation Visits Vietnam and Thailand, Strengthens Cooperation with MoU Signing

Myriad Genetics Announces Incorporation of its Proprietary HRD platform in Illumina’s Updated Comprehensive Gene Panel Assay, TruSight™ Oncology 500 v2

Tagomics Announces a Multiomic Profiling Co-Marketing Agreement with Agilent

Stay in touch with CACLP News

We deliver the latest IVD news straight to your inbox. Stay in touch with CACLP News, sign-up for our newsletter today.

  • Name *
  • Email *
  • Company name *
  • Country *
    CACLP - The largest IVD Expo & Conference

By subscribing our newsletter, you agree to our Privacy Policy. You can unsubscribe at anytime.

Share
Opening Countdown
0 0 0

Day(s)

0 0

Hour(s)

0 0

Min(s)

Visitor registration Book your stand
CACLP - The largest IVD Expo & Conference
CACLP - The largest IVD Expo & Conference CACLP - The largest IVD Expo & Conference CACLP - The largest IVD Expo & Conference CACLP - The largest IVD Expo & Conference

Room 2201-2203 & 2205, Cloud Nine Plaza
1118 West Yan’an Road
Shanghai, China
200052

Visit Exhibit Conferences Webinars Newsroom About Us FAQs

Copyright © 2024 GL events Ruihe (Shanghai) Exhibition Co., Ltd. All Rights Reserved. ( 沪ICP备12004745号-1 )

Privacy Policy & Cookies Sitemap

We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy & Cookies for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

No, thanks. Yes, I agree.
CACLP - The largest IVD Expo & Conference

Subscribe to CACLP News

We deliver the latest IVD news straight to your inbox. Stay in touch with CACLP News.
sign-up for our newsletter today.

  • Name *
  • Email *
  • Telephone
  • Job title
  • Company name *
  • Country *
    CACLP - The largest IVD Expo & Conference

By submitting the form here, you agree to our Privacy Policy and agree that we may store and access the information you provide.

Subscribe to <span>CACLP News</span>
CACLP - The largest IVD Expo & Conference
Thank you for subscribing to CACLP News!

Thank you for subscribing to CACLP News!

To ensure our newsletter hit your inbox, make sure to add @caclp.com to your safe senders list. And, as always, feel free to contact
us with any questions and thanks again for subscribing.

CACLP - The largest IVD Expo & Conference Go back
CACLP - The largest IVD Expo & Conference