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LabCorp Announces Launch of New Companion Diagnostic for Non-Small Cell Lung Cancer

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) recently announced the availability of a new application for the companion diagnostic associated with the use of Tarceva® for the treatment of certain patients with non-small cell lung cancer (NSCLC). The Roche cobas® EGFR Mutation Test v2 is the first blood-based test approved for clinical use in the U.S. to detect certain epidermal growth factor receptor (EGFR) gene mutations in NSCLC patients. LabCorp played a key role in making the test available upon approval by the U.S. Food and Drug Administration (FDA) and is the only national laboratory currently offering the test.

QIAGEN companion diagnostic wins FDA approval for use with IRESSA

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today received U.S. marketing (PMA) approval of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca’s IRESSA® (gefitinib) in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). QIAGEN’s therascreen EGFR test was approved by the Food and Drug Administration to enable doctors to identify NSCLC patients who have tumors that are positive for epidermal growth factor receptor (EGFR) mutations and therefore are eligible for treatment with AstraZeneca’s drug.

Biodesix Launches GeneStrat Targeted Liquid Biopsy Mutation Test For Patients With Advanced Lung Cancer

Biodesix, Inc. recently announced the launch of GeneStrat™, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer (NSCLC). The blood test results are available within 72 hours, providing physicians actionable diagnostic information prior to making treatment decisions. GeneStrat is focused exclusively on the clinically actionable EGFR, KRAS, and BRAF mutations often used to guide targeted therapy treatment decisions. GeneStrat also captures the EGFR T790M mutation, which can be used for monitoring the emergence of the primary resistance mutation in the EGFR gene. It is anticipated that two drugs targeting the resistance mutation may be available later this year. GeneStrat uses the ddPCR platform to analyze cell-free tumor DNA and is highly concordant with tissue analysis, currently considered the gold standard.

Majority of Lung Cancer Treatment Decisions are not Guided by Patient’s Genetic Makeup, According to New International Survey

Despite the majority of newly diagnosed advanced non-small cell lung cancer (NSCLC) patients being tested for genetic mutations, a gap still exists for providing a personalized treatment plan for patients based on their cancer type and mutation subtype, according to a new international survey. About 60 percent of surveyed U.S. oncologists do not determine their treatment decisions based on EGFR mutation subtype, compared with 50 percent in Canada and 23 percent in Asia. The survey, sponsored by Boehringer Ingelheim, was recently presented as a late-breaking abstract in the ESMO-IASLC Best Abstracts session at the 2015 European Lung Cancer Conference in Geneva, Switzerland.

QIAGEN Announces Broad Agreement With Astellas Pharma to Develop Companion Diagnostics

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced a master collaboration agreement with Astellas Pharma Inc., an R&D-driven global pharmaceutical company headquartered in Japan, to develop and commercialize companion diagnostics paired with Astellas drugs for use in cancer and other diseases. The scope of the agreement is not restricted to certain sample types, platforms, indications or biomarkers, thereby giving Astellas access to QIAGEN’s development capabilities for assays based on PCR, NGS and multi-modal testing technologies using liquid and tissue biopsies. Two initial projects in the collaboration focus on oncology and aim to pair QIAGEN diagnostics with Astellas compounds in early-stage clinical trials: ASP5878, a fibroblast growth factor receptor (FGFR) inhibitor, and ASP8273, an EGFR inhibitor. Financial terms were not disclosed.