cobas EGFR Mutation Test v2 (CE-IVD) now approved for use with Roche's Cell-Free DNA Collection Tube (CE-IVD)

Expanding the use of liquid biopsy for NSCLC patients needing molecular testing

Extended from the standard K2EDTA tube, the cobas® EGFR Mutation Test v2 (CE-IVD) is now approved for use with the Roche Cell-Free DNA Collection Tube (CE-IVD) for plasma sample types. This offers enhanced flexibility in the transport and storage of collected blood prior to plasma separation, and facilitates the use of liquid biopsy for non-small cell lung cancer (NSCLC) patients needing molecular testing.

Up to 30% of advanced NSCLC patients do not have enough tissue specimen available for molecular analysis1, and ~15-18% of patients report clinical complications associated with tissue biopsy2. Liquid biopsy testing with the cobas® EGFR Mutation Test v2 provides healthcare professionals a clinically validated, non-invasive alternative for patients who may not be healthy enough for a tissue biopsy.


Key features and benefits of the Cell-Free DNA Collection Tube


  • 8 mL blood volume
  • Blood is stable up to 7 days at room temperature* prior to plasma separation
  • K3EDTA anticoagulant plus preservatives prevents lysis of nucleated blood cells, and prevention of cfDNA dilution

*18°C to 30°C, with transient excursions up to 16 hrs to 15-30°C

  1. Spicer J, et al ELCC 2015 Poster LBA2_PR 17 April 2015
  2. Weiner RS et al, Ann Intern Med 2011
collection tube

cobas® EGFR Mutation Test v2

The only clinically validated and FDA-approved test for detecting EGFR mutations in plasma for NSCLC