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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.

Biognosys Announces a Technological Breakthrough in the Development of Its Next-Generation Proteomics Workflow

Biognosys AG announced today a breakthrough in the development of its next generation proteomics technology that helps scientists to understand complex biological processes. For the first time, Biognosys’ data-independent acquisition (DIA) mass spectrometry workflow has identified and quantified more peptides than sequentially possible with data dependent acquisition (DDA) on a Thermo Scientific™ Q Exactive™ HF. The DIA method now provides a clear path to the ultimate life science community goal – to quantify every protein, the complete proteome, in a biological sample of interest. The results of the study have recently been published in the journal Molecular and Cellular Proteomics.

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.

Recently Identified Biomarker Could Be Valid Diagnostic Tool for Gaucher Disease, Mouse Study Suggests

Glucosylsphingosine (lyso-Gb1), a recently identified biomarker for Gaucher disease (GD), was shown to contribute to the development or peripheral symptoms in a mouse study, potentially validating its use as a diagnostic tool, according to new research. The study, “Glucosylsphingosine Causes Hematological and Visceral Changes in Mice—Evidence for a Pathophysiological Role in Gaucher Disease,” was published in the International Journal of Molecular Sciences.

So My Brain Amyloid Level is “Elevated”—What Does That Mean?

Testing drugs to prevent or delay the onset of Alzheimer’s dementia and using them in the clinic will mean identifying and informing adults who have a higher risk of Alzheimer’s but are still cognitively normal. A new study from the Perelman School of Medicine at the University of Pennsylvania has shed light on how seniors cope with such information.