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FDA has approved Qiagen39s therascreen EGFR test as a companion

FDA has approved Qiagen39s therascreen EGFR test as a companion


Proposed Algorithm for Detection of EGFR Mutations in Clinical Practice

The approval for osimertinib, formerly known as AZD9291, was based on the multicenter, single- arm, AURA extension and AURA trials in a total of 411 ...

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Example of diagnostic testing algorithm for NSCLC patients to determine proper course of treatment. (click on image to enlarge)

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NOTE: BRAF, EGFR, HER2, KRAS, MEK, NRAS, and PIK3CA are genes detected by biomarker tests; EMA = European Medicines Agency; ...

cobas EGFR Mutation Test workflow. EGFR, epidermal growth factor receptor; FFPE, formalin

Delineating disease progression for EGFR-mutant non–small cell lung cancer. TKI, tyrosine kinase inhibitor; PD, progressive disease; SRS, ...

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Is ctDNA reliable for determining the presence or absence of EGFR mutation?

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Qiagen has won a Premarket Approval (PMA) supplement expanding FDA authorization of the company's therascreen EGFR RGQ PCR Kit (pictured) as a companion ...

... the therascreen KRAS test. 5.

Agreement analysis between EGFR PCR test and LDT.

Proposed flow-chart of RAS analysis with the combination of different techniques. After the

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Fig. 4

EGFR test by numbers

EGFR Signaling Cascade and Therapeutic Targets

Percent Agreement Between the cobas Plasma Test and cobas Tissue Test

In total only 8.8 % of all tested lung cancer patients are found to be EGFR mutated and 1.3 % has an ALK translocation.

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Fig. 1

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Best Practices For Communication between IND Sponsors and FDA During Drug Development


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Qiagen_Therascreen 400 The Therascreen EGFR ...

QIAGEN's companion diagnostic business highlighted in the Journal of Precision Medicine

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Gefitinib in complex with mutated EGFR

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Targets and technology: companies with companion drug-diagnostic products.

On July 13, 2015, the FDA approved gefitinib (Iressa) for the treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor ...

FDA approved


KRAS test tube. The FDA approval for QIAGEN's therascreen ...

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J Cancer Image

Genetic tests for breast cancer, lung cancer and melanoma .

Best Practices: FDA and IND Sponsor Communications

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Among eight patients with EGFR tested in CSFTCs, six patients matched with primary tissues and resistant gene T790M was identified in two cases.Figure 1

Figure 1: EGFR mutations in EGFR kinase domain. EGFR = Epidermal growth factor receptor

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Excluded from the table above are undeveloped land and leased properties that have been abandoned and certain buildings that we still own but are no longer ...

Personalized Medicine in Lung Cancer

Integrating liquid biopsies into the management of cancer | Nature Reviews Clinical Oncology

Abbott, Abbott Park, Ill, has received FDA approval to expand the use of its RealTime HIV-1 assay to run on Abbott's mPlus. In April, Abbott introduced ...

FDA Finalizes Policy on Use, Approval of Companion Diagnostics

Companion Diagnostics for Cancer


... affect the extent to which all patients, regardless of biomarker status, should be evaluated in the development programme of a drug and its companion ...

Non–small cell lung cancer. Performance status sca

Current companion diagnostics in advanced colorectal cancer; getting a bigger and better piece of the pie - Loree - Journal of Gastrointestinal Oncology

Fig. 1. Receiver operating characteristic (ROC) plot of true positive rate vs. false positive rate. A perfect model of biomarker data has an AUC of 1.0, ...

AST2818 was well tolerated and had promising clinical activity with durable disease control in EGFR T790M mutant NSCLC after first-generation EGFR-TKIs ...

US FDA approves TAGRISSO® (osimertinib) blood-based T790M companion diagnostic test

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mAb (target), Companies, Global 2011 sales (US$ billions)*, Expiry of constraining product patent*

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Figure 2

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The mechanisms by which mAb-based drugs can induce their therapeutic effects. Unconjugated antibodies

Fig. 12

Figure 1.

Biomarker development in the precision medicine era: lung cancer as a case study | Nature Reviews Cancer


Example of a Laboratory Workflow

PCR strip test tubes and micropipette in genetics laboratory. Toned photo

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Extended RAS Panel

Fig. 1

Figure 1

Flow chart of histology and molecular diagnosis for advanced NSCLCs and the optimized sampled types recommended

Figure 1



Development of Tissue-Based Companion Diagnostics: The Relationship Between the Pharmaceutical Company, Diagnostic Partner, and the Biomarker Laboratory | ...

Trouble on the Horizon: Laboratory Developed Tests and the FDA

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Clinical trial evaluating the safety data for adverse events

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