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MASS General researchers show ddPCR brain tumor liquid biopsy assay has tenfold improvement in sensitivity over any prior assay
Genetic mutations that promote the growth of the most common type of adult brain tumors can be accurately detected and monitored in blood samples using an enhanced form of liquid biopsy developed by researchers at Harvard-affiliated Massachusetts General Hospital (MGH). [...]
FDA approves first liquid biopsy next-generation sequencing companion diagnostic test
Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a [...]
Phage Testing of Bacterial Cultures
Regulatory agencies require companies using microbial cell lines that produce products for human use to regularly complete biosafety testing to ensure that cell banks are free of phage contamination. Bacteriophage (phage) is a virus that infects and replicates within [...]
NGS for Biologics Development Support
NGS represents a technological leap that has potential to revolutionize drug discovery and development. Next Generation Sequencing (NGS) has the potential to unlock causative factors from our genetic material. NGS also represents a technological advancement using array-based sequencing that [...]
Avance Biosciences™ Completes Successful FDA Inspection
HOUSTON, Oct. 30, 2018 - Avance Biosciences™, Inc., a leading biological testing company supporting drug development and manufacturing, announced today that its Houston facility was inspected by the U.S. Food and Drug Administration on October 01 through October 04, 2018. [...]
Digital PCR Services
Digital PCR (dPCR) provides precise and absolute quantification of nucleic acids without a standard curve and without dependence on amplification efficiency.Digital PCR is ultrasensitive; therefore, appropriate for testing allelic variants and targets of low abundance that are below the sensitivity limit of QPCR. It is also very precise, and is a better tool than QPCR when precise determination of the ratio of several nucleic acid sequences is required.