COBAS EGFR MUTATION TEST PDF

This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor EGFR gene mutations in non-small cell lung cancer patients. Lung cancer is the leading cause of cancer-related death among men and women in the U. According to the National Cancer Institute, an estimated , Americans will be diagnosed with lung cancer, and , will die from the disease this year. NSCLC is the most common type of lung cancer.

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They can provide testing in people who are unable to, or do not wish to, have a tissue biopsy and whose disease otherwise would remain untested. Introducing plasma EGFR mutation testing may lead to quicker test results and treatment changes as it removes the need for a tissue biopsy in certain circumstances.

Plasma EGFR mutation testing also avoids problems with tumour evolution and heterogeneity, when the presence of mutations may be missed in a biopsy of a single metastatic site or from using an existing sample. This method can detect resistance mutations — predominantly TM — which may need different treatment. This is still being researched and not in clinical use.

If the results suggest lung cancer, a contrast-enhanced computed tomography CT scan of the chest, upper abdomen and lower neck is done to evaluate the degree of mediastinal and chest wall invasion. Further investigations to confirm a diagnosis and to provide information on the stage of the disease are then done.

The tumour sample is used for EGFR mutation testing. The guidance notes that tests and methods are evolving, so new ones are likely to appear in the future. People who cannot have, or do not want, a tumour biopsy do not routinely have EGFR testing by other means such as plasma EGFR testing or next-generation sequencing [NGS] and usually have first-line chemotherapy with a single third-generation drug docetaxel, gemcitabine, paclitaxel or vinorelbine and a platinum drug carboplatin or cisplatin.

People who cannot tolerate a platinum combination may be offered single-agent chemotherapy with a third-generation drug. Their disease may either be untreated or relapsing after previous TKI therapy. A blood sample would be taken by a phlebotomist. Sample preparation and test procedures would be completed by pathology laboratory staff. The results are used to aid decision-making by clinicians and the patient.

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FDA Expands Approval of Roche Cobas Test as CDx for EGFR Deletions, Mutations

It consists of the cobas x instrument for the nucleic acid extraction sample preparation and PCR pipetting and the cobas z real-time PCR analyzer. CO-RE tip technology Improves sealing by securely locking pipette tips in place with an O-ring that expands smoothly to fit a specially designed groove. A proprietary Total Aspirate and Dispense Monitoring TADM system Ensures valid results by monitoring the pressure within tips to detect low volumes and clogs; pressure responses that fall outside the expected range are reported as errors. Five optical channels To detect multiple targets from one reaction tube. Designed for bi-directional LIS communication To simplify test ordering while supporting integrity of results no manual data entry required.

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Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Solid Tumor

In the study, treatment with Tarceva demonstrated that patients lived longer without their disease getting worse median progression-free survival; Tarceva is also approved for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen second- or third-line treatment. Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC. Tumour shrinkage response rate was observed in 65 percent of patients with Tarceva and in 16 percent of people treated with chemotherapy.

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