BioCentury | Jun 1, 2019
Product Development

Clinical trial and regulatory efficiency get help from ctDNA, RWE at ASCO19

...EGFR mutant ctDNA as an exploratory endpoint ( 9020 ). AZ and Roche market the Cobas EGFR Mutation Test v2...
BioCentury | Apr 13, 2019
Tools & Techniques

ctDNA inches toward new applications

...profile tumors and stratify patients for trials. One assay has been approved by FDA, the Cobas EGFR Mutation Test v2...
...to targeted therapies or immunotherapies. Lung tissue biopsies are also difficult to obtain. The FDA-approved Cobas EGFR Mutation Test v2...
BioCentury | Feb 1, 2019
Clinical News

OncoCyte's lung cancer liquid biopsy test shows 90% sensitivity

...least one FDA-approved liquid biopsy test for lung cancer. FDA approved in 2016 the PCR-based Cobas EGFR Mutation Test v2...
BioCentury | Jan 29, 2019
Clinical News

OncoCyte's lung cancer liquid biopsy test shows 90% sensitivity

...least one FDA-approved liquid biopsy test for lung cancer. FDA approved in 2016 the PCR-based Cobas EGFR Mutation Test v2...
BioCentury | Feb 23, 2018
Clinical News

Guardant gets EAP from FDA for NGS-based liquid biopsy

...from blood. So far, FDA has only approved one liquid biopsy test -- the PCR-based Cobas EGFR Mutation Test v2...
...available in over 30 countries. Guardant Health Inc., Redwood City, Calif. Product: Guardant360 Business: Diagnostic Allison Johnson Cobas EGFR Mutation Test v2 Guardant360 AstraZeneca...
BioCentury | Feb 17, 2018
Company News

FDA grants EAP designation to Guardant's NGS-based liquid biopsy

...from blood. So far, FDA has only approved one liquid biopsy test -- the PCR-based Cobas EGFR Mutation Test v2...
...marketed as a laboratory-developed test (LDT) since 2014 and is available in over 30 countries. Allison Johnson Cobas EGFR Mutation Test v2 Guardant360 AstraZeneca...
BioCentury | Jan 4, 2018
Strategy

Next generation resolutions

...CFTR2 database, in peripheral whole blood cells Not applicable June 2016 First liquid biopsy-based diagnostic cobas EGFR Mutation Test v2...
BioCentury | Oct 10, 2017
Politics & Policy

AZ, MSKCC highlight challenges in broader use of liquid biopsy

...of liquid biopsy tests to replace tissue biopsies to assess genomic alterations in cancer. The Cobas EGFR Mutation Test v2...
BioCentury | Feb 17, 2017
Strategy

Putting genes to the test

...unambiguous drug recommendation. Last year, AstraZeneca and Roche’s PCR-based blood test for EGFR T790M, the Cobas EGFR Mutation Test v2...
BioCentury | Oct 10, 2016
Clinical News

Cobas EGFR Mutation Test v2 regulatory update

...FDA approved a PMA from Roche for a blood-based version of its cobas EGFR Mutation Test v2 as a companion...
...4, 2014). AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas EGFR Mutation Test v2 (cobas EGFR Mutation Test v2...
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