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Roche Receives FDA Approval for VENTANA ALK (D5F3) CDx Assay to Identify Lung Cancer Patients Eligible for Treatment with Roche’s ALECENSA (alectinib)

Roche recently announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Roche medicine ALECENSA® (alectinib). The VENTANA ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.

Biodesix Blood-Based Diagnostic Testing Approach To PD-L1 Detection Shows Concordance with Immunohistochemistry

Biodesix presented preliminary data evaluating a blood-based PD-L1 assay to identify patients who may benefit from cancer immunotherapies. The data were presented last week at the AACR-NCI-EORTC conference. The study was conducted in collaboration with Dr. Michael Pritchett, from FirstHealth Moore Regional Hospital, Pinehurst Medical Clinic, and Dr. Jiaxin Niu, from Banner MD Anderson Cancer Center.

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.

Biocept to Collaborate on Biopharma Company Clinical Trial by Identifying Biomarkers Found in Cerebral Spinal Fluid for Patients with Lung Cancer that has Spread to the Brain

Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer, announces a collaboration on a biopharmaceutical company clinical trial analyzing biomarkers using both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) from cerebrospinal fluid (CSF). The trial is being conducted in patients with non-small cell lung cancer (NSCLC) whose disease has spread to the brain or membranes surrounding the brain and spinal cord, known as leptomeningeal disease.

QIAGEN Partners to Develop Novel Companion Diagnostic in Lung Cancer

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced a partnership with Mirati Therapeutics, Inc. (NASDAQ: MRTX) to co-develop and commercialize a companion diagnostic test to guide the use of Mirati’s glesatinib (MGCD265), a targeted therapy under development for non-small cell lung cancer (NSCLC). The companies aim to create a regulator-approved test to personalize treatment decisions in NSCLC by detecting RNA biomarkers produced by exon 14 skipping mutations of the MET gene.