Specialty Pharma Journal Specialty, Precision & Technology
SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies® announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo designation for the clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from a patient’s bone marrow sample. The clearance …
Tag Archives: NGS
October, 2018
May, 2018
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31 May
Castle Biosciences Launches Next-Generation Sequencing Test DecisionDx-CMSeq for Cutaneous Melanoma
FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer treatment decisions, today announced the launch of the DecisionDx®-CMSeq test that uses next-generation sequencing (NGS) to identify somatic mutations in genes relevant to cutaneous (skin) melanoma (CM). The DecisionDx-CMSeq NGS test will provide additional information to …
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31 May
Adaptive and Sanofi Collaborate to Use Adaptive’s clonoSEQ Assay in Active and Future Isatuximab Multiple Myeloma Trials
SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies, the leader in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announced today that it entered into an agreement with Sanofi to utilize Adaptive’s NGS-based clonoSEQ® Assay to assess minimal residual disease (MRD) status in response to …
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15 May
Illumina Acquires Edico Genome to Accelerate Genomic Data Analysis
mina SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) today announced that it acquired Edico Genome, the leading provider of data analysis acceleration solutions for next-generation sequencing (NGS). Edico Genome’s DRAGEN® Bio-IT Platform (DRAGEN) uses field programmable gate array (FPGA) technology in conjunction with proprietary software algorithms to reduce both data footprint and time to …
April, 2018
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16 April
Bristol-Myers Squibb and Illumina Partner for Companion Diagnostics for Oncology Immunotherapies
NEW YORK & SAN DIEGO–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Illumina, Inc. (NASDAQ: ILMN) today announced a collaboration that will utilize Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb’s oncology portfolio. The companies plan to develop a diagnostic version of the Illumina …
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13 April
FDA Finalizes Guidances to Accelerate the Development of Reliable, Beneficial Next Generation Sequencing-Based Tests
The U.S. Food and Drug Administration today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments. The guidances provide recommendations for designing, developing, and validating tests that use the technology, …
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10 April
Illumina and Loxo Oncology Partner for Development of Next-Generation Sequencing-Based Pan-Cancer Companion Diagnostics
SAN DIEGO & STAMFORD, Conn.–(BUSINESS WIRE)–Illumina, Inc. (Nasdaq: ILMN) and Loxo Oncology (Nasdaq: LOXO) today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication. The co-development partnership will …
August, 2017
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16 August
Liquid Biopsies Find Distinct Genomic Profiles in Most Patients with Carcinoma of Unknown Primary
PHILADELPHIA — Next-generation sequencing of circulating tumor DNA (ctDNA) identified distinct genomic profiles with potentially targetable alterations in 99.7 percent of patients with carcinoma of unknown primary (CUP) who have detectable alterations, according to results published in Cancer Research, a journal of the American Association for Cancer Research. “Our research is the first …
July, 2016
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7 July
FDA Advances Precision Medicine Initiative with Draft Guidances on NGS-Based Tests
In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration today issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. The powerful new technology, known as …
January, 2016
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27 January
Illumina Acquires Conexio Genomics
Building on Illumina’s work to develop next-generation sequencing (NGS) solutions for the HLA typing market, Illumina recently announced its acquisition of Conexio Genomics, a world leader in the development of HLA typing solutions. “The addition of Conexio products and people solidify our HLA capabilities and demonstrate Illumina’s ongoing commitment to …