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SkylineDx Receives CE-IVD Mark for its Gene Signature-Based Test for Multiple Myeloma

ROTTERDAM, Netherlands and LAGUNA HILLS, Calif., Nov. 25, 2015 /PRNewswire/ — SkylineDx, today announced they have received CE-IVD registration from the European Competent Authority (Ministry of Health) for the MMprofiler™, the company’s prognostic test to determine the level of risk of a patient with multiple myeloma (MM). SkylineDx is an emerging …

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Mallinckrodt Pharmaceuticals Receives FDA Clearance For INOmax DS(IR) Plus MRI Device

CHESTERFIELD, United Kingdom, Nov. 16, 2015 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared INOmax DSIR® Plus MRI device for delivery of INOMAX® (nitric oxide) for inhalation during MRI procedures. The INOmax DSIR Plus MRI …

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Exact Imaging Introduces Prostate Risk Identification Protocol

BARCELONA, Spain and TORONTO, Nov. 12, 2015 /CNW/ – Exact Imaging (www.exactimaging.com), the world’s leader in high–resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, today introduces PRI-MUS™, the first Prostate Risk Identification Protocol using Micro-Ultrasound. This new protocol, the first of its kind in prostate ultrasound, aims …

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Morphotek Enters License Agreement with Blaze Bioscience for Novel Oncology Imaging Technology

EXTON, Pa., Nov. 9, 2015 /PRNewswire/ — Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has entered into a license agreement with Blaze Bioscience, Inc. of Seattle, WA, a privately held biotechnology company developing Tumor Paint technology.  Under the agreement, Morphotek provides to Blaze an exclusive, worldwide, royalty-bearing …

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Natera’s mmPCR Technology Successfully Identified breast Cancer in Study

SAN CARLOS, Calif., Oct. 28, 2015 /PRNewswire/ — Natera, Inc., (NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced a study published in the October 2015 issue of Translational Oncology showing that Natera’s massively multiplexed PCR (mmPCR) technology and proprietary analytic methodologies can detect …

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Vertex Pays $105 Million to CRISPR Therapeutics for Gene Editing Technology

BOSTON & CAMBRIDGE, Mass.–(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) and CRISPR Therapeutics today announced that the two companies have entered into a strategic research collaboration focused on the use of CRISPR’s gene editing technology, known as CRISPR-Cas9, to discover and develop potential new treatments aimed at the underlying genetic causes …

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Metamark’s Novel Prognostic Test Demonstrates Potential to be Cost-Effective for Management of Prostate Cancer

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Metamark Genetics, Inc. (“Metamark” or the “Company”), a leader in commercializing high-value urologic oncology products, today announced that a study published in The Oncologist demonstrates that use of its novel proteomic prognostic test ProMark®, for early-stage prostate cancer, is likely to result in more cost-effective care than the National …

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Gamma Medica Receives CE Mark for its Molecular Breast Imaging System LumaGEM

SALEM, N.H., Oct. 12, 2015 /PRNewswire/ — Gamma Medica, Inc., a breast imaging medical device company, today announced the CE Mark approval allowing for the sale and distribution of the LumaGEM® Molecular Breast Imaging (MBI) system within the European Economic Area (EEA). Gamma Medica is finalizing distribution partners in strategic markets across the EEA. …

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Sequenom Partners with UKE to Test Utility of Liquid Biopsy in Colorectal Cancer

SAN DIEGO, Oct.12, 2015 /PRNewswire/ — Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the development of innovative products and services, today announced that it has entered into a clinical collaboration with University Medical Center Hamburg-Eppendorf (UKE) in Germany. UKE and Sequenom will collaborate to profile circulating …

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