FierceBiotech

FDA approves Qiagen EGFR companion diagnostic to Pfizer’s Vizimpro in first-line NSCLC

The FDA has granted Qiagen’s Therascreen EGFR RGQ PCR Kit approval for use as a companion cancer diagnostic for Pfizer’s Vizimpro, to identify non-small cell lung cancer patients with specific genetic ...
Business Wire

QIAGEN Receives Approval for EGFR Test in Lung Cancer as Companion Diagnostic in Japan

HILDEN, Germany, and TOKYO--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the Japanese Pharmaceuticals and Medical Device Agency (PMDA) has approved the ...
Nasdaq

Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer

- Lung cancer causes more than 1.7 million deaths worldwide each year, with NSCLC accounting for about 85 percent of all cases[1] - The cobas EGFR Mutation Test v2 is FDA approved as a companion ...
Business Wire

Biocept and Protean BioDiagnostics Establish Research Collaboration to Demonstrate Advantages of Biocept’s Target Selector™ Assay Kit for Non-Small Cell Lung Cancer Patients

SAN DIEGO--(BUSINESS WIRE)--Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, will collaborate with Protean BioDiagnostics Inc. to research the ...
National Institute for Health and Care Excellence

EGFR‑TK mutation testing in adults with locally advanced or metastatic non-small-cell lung cancer

To ensure it complies with the CE marking, the DNA is first isolated from a specimen of formalin-fixed paraffin-embedded tissue using the QIAamp DNA FFPE Tissue Kit. The total amount of DNA in the ...
GEN

Health Canada Clears DxS’ K-RAS Mutation Kit as Test for Anti-EGFR Therapies

It can assess patients’ suitability for Amgen’s colorectal cancer drug, Vectibix. Canadian regulatory authorities approved DxS’ TheraScreen K-RAS Mutation Kit for use as a diagnostic for anti-EGFR ...
FierceBiotech

Roche and Clovis Oncology to Co-Develop EGFR Companion Diagnostic

BOULDER, Colo., and PLEASANTON, Calif., June 2, 2011 /PRNewswire/ -- Clovis Oncology, Inc. and Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today that they have entered into an agreement to develop ...
ascopubs.org

EGFR testing by a new diagnostic method to detect point mutations, deletions and insertions associated to non small cell lung cancer: CLART CMA EGFR.

EML4-ALK rearrangement detection in malignant pleural effusions from patients with advanced non-small cell lung cancer: Feasibility and predictive value. This is an ASCO Meeting Abstract from the 2015 ...
ascopubs.org

EGFR Mutations in Non–Small-Cell Lung Cancer: Analysis of a Large Series of Cases and Development of a Rapid and Sensitive Method for Diagnostic Screening With Potential ...

Mutations in the EGFR tyrosine kinase domain define a new molecular type of lung carcinoma, more frequent in particular subsets of patients. The SSCP assay is a rapid and reliable method for the ...