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Technology & Devices

Personal Genome Diagnostics’ TMB Analysis Shows Promising Checkpoint Inhibitor Efficacy in Early-Stage Lung Cancer Study

BALTIMORE, April 19, 2018 /PRNewswire/ — Personal Genome Diagnostics Inc. (PGDx) today reported that its whole exome analysis platform contributed to an important new study published in the New England Journal of Medicine (NEJM) showing promising efficacy for a leading checkpoint inhibitor in early stage lung cancer.1 The study also …

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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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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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FDA Permits Marketing of Artificial Intelligence-Based Device to Detect Certain Diabetes-Related Eye Problems

The U.S. Food and Drug Administration today permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the …

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Foundation Medicine and its Collaborators Present New Findings Supporting Comprehensive Genomic Profiling for Targeted Treatment

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced the presentation of new findings at the American Association for Cancer Research (AACR) Annual Meeting. The data supports the use of both tissue- and blood-based comprehensive genomic profiling (CGP) to advance personalized cancer care and inform the use of targeted and immunotherapy treatment …

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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 …

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Agilent Technologies to Acquire Lasergen for $105 Million

SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) and Lasergen, Inc. (Lasergen) today announced that they have signed a definitive agreement for Agilent to acquire the remaining shares of Lasergen, an emerging biotechnology company focused on research and development of innovative technologies for DNA sequencing, for $105 million. In March 2016 …

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SkylineDx and Mayo Clinic Enter Strategic Collaboration to Develop Diagnostic Tests for Melanoma

ROTTERDAM, Netherlands, Jan. 31, 2018 /PRNewswire/ — SkylineDx today announced a strategic collaboration with Mayo Clinic to develop novel diagnostic tests which will improve clinical decision making for melanoma patients. For SkylineDx, the collaboration with the renowned Mayo Clinic is an important milestone as it allows the company to develop …

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FDA Approves First-Ever JAK2 Test for Use in Diagnosis of Additional Myeloproliferative Neoplasms

Hilden, Germany, and Germantown, Maryland, January 23, 2018 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has received clearance for its ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) from the U.S. Food and Drug Administration (FDA) for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs), which are …

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Ligand Enters into Worldwide OmniAb Platform License Agreement with Ferring Pharmaceuticals

SAN DIEGO–(BUSINESS WIRE)–Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces it has entered into a worldwide OmniAb platform license agreement with Ferring Pharmaceuticals. Under the license, Ferring will be able to use the full OmniAb platform including OmniRat®, OmniMouse®, OmniFlic® and OmniChicken™ to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive …

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