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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.

Study Finds Biomarker for Lung Cancer Detection in the Nasal Passages of Smokers

A new nasal test may allow patients suspected of having lung cancer to undergo a simple swab of their nose to determine if they have the disease. Researchers at Boston University School of Medicine (BUSM) have found that a genomic biomarker in the nasal passage can accurately determine the likelihood of a lung lesion being malignant. The findings, which appear online in the Journal of the National Cancer Institute, will allow physicians to confidently identify patients who are at low probability for having lung cancer, thus sparing them from costly and risky procedures.

Biodesix and Bioyong Announce Agreement for Joint Development and Commercialization of VeriStrat Test in Greater China

Biodesix, Inc. (Boulder, CO, USA) and Bioyong Technology Company Ltd. (Beijing, China) announced today that they have entered into an international collaboration agreement where Bioyong will develop and commercialize a version of Biodesix’s VeriStrat® proteomic blood test, a precision medicine diagnostic for patients with non-small cell lung cancer (NSCLC), for clinical use in Greater China, with potential expansion into other Asia-Pacific countries.

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.