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FDA Issues New Guidelines on Clinical and Nonclinical Genomic Biomarkers

The U.S. Food and Drug Administration (FDA) has issued new guidelines on biomarkers related to drug or biotechnology product development. The guidance was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

NextGen Sciences Launches Multiplex Protein CSF Biomarker Assay for Parkinson’s Disease

NextGen Group plc is pleased to announce that its US-subsidiary NextGen Sciences Inc, a leader in biomarker discovery, measurement and qualification, has launched its csfparkinsons22 multiplex CSF protein assay for Parkinson’s disease. The assay simultaneously measures 22 human CSF (cerebrospinal fluid) proteins that are believed to have potential as biomarkers for the disease.

NextGen Sciences Launches Multiplex Protein CSF Biomarker Assay for Multiple Sclerosis

NextGen Group plc is pleased to announce that its US-subsidiary NextGen Sciences Inc, a leader in biomarker discovery, measurement and qualification, has launched its csfmultiplesclerosis25 multiplex protein assay for multiple sclerosis. The assay simultaneously measures 25 human CSF (cerebrospinal fluid) proteins that are believed to have potential as biomarkers for the disease.

NextGen Sciences Launches Multiple Protein Cerebrospinal Fluid (CSF) CNS Disease Biomarker Assay

NextGen Group plc is pleased to announce that its US-subsidiary NextGen Sciences Inc, a leader in biomarker discovery, measurement and qualification, has launched its first cerebrospinal fluid (CSF) multiple protein (multiplex) assay, csfdiscovery43, for central nervous system (CNS) biomarker discovery and qualification. The assay simultaneously measures 43 human CSF proteins that are thought to have potential as biomarkers in CNS diseases, particularly Alzheimer’s, Parkinson’s, multiple sclerosis and ALS diseases. The launch of csfdiscovery43 is the next step in NextGen Sciences strategy of becoming a leading player in the growing CNS and oncology biomarker markets.

NINDS to Fund Biomarker Clinical Study for Spinal Muscular Atrophy

SMA is associated with a mutation in chromosome 5 — loss of the survival of motor neuron 1 gene (SMN1) — and is considered the second most common autosomal recessive disease in the US, affecting 1 in 6000 live births. SMA Type 1 is one of the most common genetic causes of infantile death. Although the disease can be readily diagnosed, there are no approved treatments for SMA.