Cobas egfr mutation test v2 pdf

Circulating tumor dna management of nonsmallcell lung. Jun 02, 2016 the fda approved the cobas egfr mutation test v2 to detect gene mutation associated with nonsmall cell lung cancer. The egfr gene provides instructions for a cell to make a specialized type of protein called a receptor, which is located on the. Profile of the roche cobas egfr mutation test v2 for nonsmall. At the time of writing, cobas egfr mutation test is used by 7 nhs hospitals. K aktivaci mutaci genu receptoru egfr dochazi zvlaste pri nsclc a tato aktivace vede k nezbytne aktivaci cinnosti kinazy bilkoviny egfr, coz prispiva k procesu onkogeneze. Molecular testing of egfr is required to predict the response likelihood to targeted therapy in nonsmall cell lung cancer. Unkontrollierte zellproliferation bei patienten mit mutation im. Our answers your insights life science research solutions key features and benefits the kras mutation test v2 lsr from roche is an allelespecific, realtime pcr test for the qualitative detection and identification of exon 2, 3, and 4 mutations. Tumor tissue biopsy samples were tested for t790m during screening with the cobas egfr mutation test cobas tissue.

Eligible patients had advanced or recurrent nsclc with known tki. The cobas egfr mutation test v2 test in plasma cobas v2 plasma test was compared to next generation sequencing ngs and the ppa and npa for exon 19 deletions and l858r were 87. Our answers your insights life science research solutions key features and benefits the kras mutation test v2 lsr from roche is an allelespecific, realtime pcr test for the qualitative detection and identification of exon 2, 3, and 4 mutations in the vkiras2 kirsten rat sarcoma viral oncogene homolog kras gene from. Defined egfr mutations are detected using dna isolated from ffpe tumor tissue or circulatingfree tumor dna cfdna from plasma derived from edta. Nov, 2019 the cobas egfr mutation test v2 is a companion diagnostic test that supports iressa as an additional therapeutic option for patients and. The cobas egfr mutation test v2 is a realtime pcr test for the qualitative detection of defined mutations of the epidermal growth factor receptor egfr gene. Cobas 4800 braf v600 mutation test product profile bciq.

Plasma samples were collected at screening and at the baseline and were retrospectively analyzed for egfr mutations with the cobas egfr mutation test v2 cobas plasma, droplet digital polymerase chain reaction ddpcr. Screening system for epidermal growth factor receptor. Tissue and plasma egfr mutation analysis in the flaura trial. Fda approved a pma from roche for a bloodbased version of its cobas egfr mutation test v2 as a companion diagnostic for tagrisso osimertinib from astrazeneca to treat egfr t790m mutationpositive, metastatic nonsmall cell lung. Request pdf profile of the roche cobas egfr mutation test v2 for nonsmall cell lung cancer introduction. Roche receives fda approval for cobas egfr mutation test v2. Detection of egfr t790m in asia pacific patients with. The cobas egfr mutation test v2 is a realtime pcr test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor. Fda approves cobas egfr mutation test v2 for patients with nsclc. Tissue and plasma egfr mutation analysis in the flaura. Training is needed in the use of all plasma egfr mutation tests assessed in this briefing.

This information is intended for us healthcare professionals only. New test is the first to be validated for use of either sample type in a single test. Fda grants first liquid biopsy approval to the roche cobas. Egfr mutation test v2 00875197005448 no description.

The cobas egfr mutation plasma test v2 is a realtime pcr test for the qualitative detection and identification of mutations in exons 18, 19, 20, and 21 of the epidermal growth factor receptor egfr gene in dna derived from plasma from nonsmall cell lung cancer nsclc patients. The egfr mutation testing landscape is manifold and includes both screening and targeted methods, each with their own pros and cons. Using the test in conjunction with the cobas 4800 system, laboratory professionals can mixbatch each run with both sample types and even samples from different patients. Mar 14, 2017 new test is the first to be validated for use of either sample type in a single test. Roche roche launches the cobas egfr mutation test v2 for. Plasma screening for the t790m mutation of egfr and phase. In certain situations, dna that has been shed from tumor cells in ones blood can also be tested and may be informative liquid biopsy. Egfr is a short name for the epidermal growth factor receptor gene. The cobas egfr mutation test v2 for use with plasma test is intended to be used to initially screen patients with metastatic nsclc for egfr mutations. Our objective was to assess the performance of the cobas test versus comparators for kras mutation status and predicting clinical response to anti epidermal growth factor receptor egfr therapy in patients with metastatic colorectal cancer mcrc. Jun 02, 2016 the agreement between the cobas egfr mutation test v2 in plasma and the cobasegfr mutation test v1 in tissue was evaluated for detection of egfr mutations ex. Comparison of cobas egfr mutation test v2 and panamutyper. The cobas egfr mutation test v2 is a realtime pcr test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor egfr gene, including the t790m resistant mutation.

The cobas egfr mutation test v2 is a realtime pcr test for the qualitative detection of defined mutations of the epidermal growth factor receptor egfr gene in nonsmall cell lung cancer nsclc patients. The cobas egfr mutation test v2 can be used with both ffpe tissue and ctdna from plasma and has been approved by the fda as a companion diagnostic test for tagrisso osimertinib, tarceva erlotinib, and iressa ge. Food and drug administration fda recently approved the cobas egfr mutation test v2 as a companion diagnostic test with gefitinib. The cobas egfr mutation test v2 not only provides clinicians with the option of using either tissue or plasma as biopsy samples, but it also makes the processing of these samples more convenient and efficient. The agreement between the cobas egfr mutation test v2 in plasma and thecobas egfr mutation test v1 in tissue was evaluated for detection of egfr mutations ex. Fourteen laboratories received two identical panels of 27 singleblinded plasma. The clinical utility of the cobas egfr mutation test v2 roche molecular systems, inc. These drugs have been shown to be useful in treating nonsmall cell lung cancer nsclc, if the tumor has a mutation making it sensitive to the drug. Dna from tumor cells is tested for mutations in this gene. The cobas egfr mutation test v2 is a realtime pcr test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor egfr gene, including the t790m resistance mutation.

Roche receives fda approval for cobas egfr mutation test v2 as a companion diagnostic for nonsmall cell lung cancer therapies nextgeneration test using tissue samples is approved for use as a. Plasma epidermal growth factor receptor egfr mutation tests are less invasive than tissue egfr mutation tests. Egfr mutation test v2 is a real time pcr test for the qualitative detection of defined mutations of the epidermal growth factor receptor egfr gene in dna derived from formalinfixed paraffinembedded tumor tissue ffpet from nonsmall cell lung cancer nsclc patients. Fda grants first liquid biopsy approval to the roche cobas egfr mutation test v2. Comparison of cobas egfr mutation test v2 and panamutyperr. The roche cobas egfr mutation test v2, based on real time rtpcr, is a reliable option for testing egfr mutations in clinical practice, either using tissuederived dna or.

Sep 28, 2015 23 about the cobas egfr mutation test v2 the cobas egfr mutation test v2 is a realtime pcr test that identifies 42 mutations in exons 1821, including l858r, exon 19 deletions, l861q and the tkiresistance mutation, t790m. The cobas 4800 system is a complete end to end solution that integrates total nucleic acid isolation, automates pcr setup and performs realtime pcr. Tumor biopsies for detecting egfr mutations in advanced nsclc are invasive, costly, and not always feasible for patients with latestage disease. Of the 227 nsclc patients, blood samples were available from 144 patients both before erlotinib treatment and at progression within 1 month before or after clinical progression.

The cobas 4800 system consists of two linked instruments. Aug, 2019 the cobas egfr mutation test v2 is a companion diagnostic test that supports iressa as an additional therapeutic option for patients and. Cobas egfr mutation test v2 brand, cobas egfr mutation. Roches cobas egfr mutation test v2 is designed to identify exon 19 deletions e19del or exon 21 l858r substitution mutations in the egfr gene in patients with nonsmall cell lung cancer nsclc eligible for treatment with erlotinib. The test a bloodbased companion diagnostic for the cancer drug erlotinib. Egfr testing for nonsmall cell lung cancer tki response. Egfr gene mutation analysis in nonsmall cell lung cancer. Roche launches the cobas egfr mutation test v2 for use. Analysis of circulating tumor dna in plasma may complement limitations of tumor tissue. If evidence is sufficient to conclude that the approved companion dignostics are interchangeable cdx gefitinib erlotinib afatinib osimertinib dacomitinib therascreen egfr mutation detection kit rgq x x x x x cobas egfr mutation test v2.

Osimertinib tagrisso and the cobas egfr mutation test v2. The cobas egfr mutation test v2 is a realtime pcr test for the qualitative detection of defined mutations of the epidermal growth factor. In order to perform a successful epidermal growth factor receptor egfr mutation test, a sufficient quantity of tumour cells is required to ensure that an adequate amount of tumour dna is extracted for analysis. If one of these sensitizing mutations is detected with an egfr mutation test, then egfrtargeted tyrosine kinase inhibitors are much more likely to be of benefit for treating the tumor. The test is intended to aid in identifying patients. Detection of egfr variants in plasma the journal of. Jan 18, 2018 training is needed in the use of all plasma egfr mutation tests assessed in this briefing. Roche launches the cobas egfr mutation test v2 for use with either plasma or tumour tissue samples.

The technologies plasma egfr mutation tests for adults with. Plasma ctdna analysis for detection of the egfr t790m. Plasma epidermal growth factor receptor egfr mutation tests are less. Novel approach for clinical validation of the cobas kras. If one of these sensitizing mutations is detected with an egfr mutation test, then egfr targeted tyrosine kinase inhibitors are much more likely to be of benefit for treating the tumor. The cobas egfr mutation test v2 is a realtime pcr test that identifies 42 mutations in exons 1821, including l858r, exon 19 deletions, l861q and the tki. This study evaluated the interlaboratory performance and reproducibility of a realtime pcr egfr mutation test cobas egfr mutation test v2 to detect egfr variants in plasma. The cobas egfr mutation test v2 is a realtime pcr test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor egfr gene, including the t790m resistant mutation it is designed to enable testing of both tissue and plasma specimens with a single kit, and allows labs to run tissue and plasma on the same plate. Laval, qc, march 14, 2017 cnw telbec roche diagnostics canada announced that health canada has approved the cobas egfr mutation test v2, the first oncology assay from roche that utilizes either plasma or tumor tissue as a sample.

Test can be used with either plasma or tumor tissue, as a companion diagnostic for non. Cobas egfr mutation test v2 brand, cobas egfr mutation test. Defined egfr mutations are detected using dna isolated from formalinfixed paraffinembedded tumor tissue ffpet or circulatingfree tumor dna cfdna from plasma derived from edta anti. Defined egfr mutations are detected using dna isolated from formalinfixed paraffinembedded tumor tissue ffpet or circulatingfree tumor dna cfdna from plasma derived from. The t790m resistance mutation in egfr is only found in. Read about fdaapproved assays and laboratorydeveloped tests that utilize different technologies to detect common sensitizing and acquired resistance egfr mutations. Profile of the roche cobas egfr mutation test v2 for non. Roche launches the cobas egfr mutation test v2 for use with. Epidermal growth factor receptor mutation analysis in. Roche molecular systems, pleasanton, ca, usa or panamutyperregfr mutyper. Details of the development of the cobas v2 plasma test to demonstrate clinical utility for selecting t790mpositive patients for. The aim of this study was to evaluate the concordance of egfr mutation detection between paired primary or recurrent samples, and cerebrospinal fluid csf cytology samples of lung cancer patients. The technologies plasma egfr mutation tests for adults. Apr 05, 2014 cobas egfr mutation test conference media design.