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Archives for January 2015

Quanterix Announces the Simoa Accelerator, an Innovation Center for Biomarker Research and Custom Assay Development

Quanterix Corporation, a leader in high definition diagnostics, delivering ultrasensitive single molecule measurement for the benefit of human health, recently announced the opening of The Simoa Accelerator, a dedicated laboratory environment for custom assay development and clinical sample testing. Designed to provide access to the revolutionary Single Molecule Array (Simoa) HD-1 Analyzer, this state-of-the-art facility allows users to experience the advantages of the technology firsthand.

ACLA Releases White Paper Detailing Legal Arguments Against FDA’s Proposal To Regulate Laboratory Developed Tests (LDTs) As “Medical Devices”

The American Clinical Laboratory Association (ACLA) recently released a white paper developed by retained expert legal counsel, former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl. M. Loeb University Professor and Professor of Constitutional Law at Harvard University. The document provides a systematic and detailed rejection of the Food and Drug Administration’s (FDA) proposal to extend its regulatory authority over laboratory developed tests (LDTs) by reclassifying LDTs as medical devices.

InformedDNA, NIA Magellan to Offer Genetic Benefits Optimization Solution

InformedDNA recently announced that it will collaborate with NIA Magellan, a division of Magellan Health, Inc. (NASDAQ: MGLN), to offer an evidence-based genetic benefits optimization program. InformedDNA’s national network of independent board-certified genetics specialists provides expert clinical review services to ensure appropriate use of genetic testing and improve patient care, while at the same time delivering significant cost savings. NIA Magellan, a division of Magellan Health, Inc. offers a suite of specialty solutions to address many complex areas of healthcare.

New Single-Cell Whole Genome Sequencing Workflow Allows Discovery of Novel Cellular Heterogeneity

Fluidigm Corporation (NASDAQ:FLDM) recently announced a new single-cell application for its C1 system that improves whole genome sequencing of individual cells. Single-cell whole genome sequencing allows researchers to explore mutations in regulatory and protein coding regions of the genome in order to identify novel signatures within heterogeneous cell populations. This application will empower cancer researchers to discover and define specific mutation profiles to predict cancer susceptibility, metastasis, and therapeutic efficacy.

Oncodesign has Entered into a Services Agreement with Eisai to Develop a New Personalized Medicine Program in Earlier Line Metastatic Breast Cancer Treatment

ONCODESIGN (FR0011766229 – ALONC), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, recently announced the signing of an agreement with Eisai Inc. Oncodesign will conduct in vivo pharmacology studies and Eisai will provide gene expression profiling analysis using Oncodesign’s patient-derived xenograft models (PDX) to investigate the potential of eribulin mesylate (“eribulin”) in earlier line treatment of metastatic breast cancer.