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GSD receives FDA Clearance for 25-OH Vitamin D Total ELISA test

Gold Standard Diagnostics, Corp., a leading manufacturer and marketer of clinical laboratory instrumentation and assays for the in vitro diagnostics market, announced 510k FDA Clearance of its 25-OH Vitamin D, Total ELISA.

24 Jul 2013

Bruker introduces AVANCE-IVDr platform for NMR clinical research and screening

Bruker today announces a standardized nuclear magnetic resonance (NMR) spectroscopy platform for its clinical and diagnostics partners that enables cost-effective, high-performance NMR clinical screening and IVD-by-NMR discovery, development and validation of novel NMR assays.

24 Jul 2013

Digital versions of standard molecular biology tool to detect common tumor-associated mutation in CSF

Massachusetts General Hospital (MGH) researchers and their colleagues have used digital versions of a standard molecular biology tool to detect a common tumor-associated mutation in the cerebrospinal fluid (CSF) of patients with brain tumors. In their report being published in the open-access journal Molecular Therapy - Nucleic Acids, the investigators describe using advanced forms of the gene-amplification technology polymerase chain reaction (PCR) to analyze bits of RNA carried in membrane-covered sacs called extracellular vesicles for the presence of a tumor-associated mutation in a gene called IDH1.

24 Jul 2013

Cepheid, American Lung Association partner to promote TB awareness in U.S.

Cepheid and the American Lung Association today announced a partnership to promote tuberculosis-related awareness in the U.S. and the need for improved TB diagnostics.

23 Jul 2013

Fibromyalgia diagnosis: an interview with Dr. Bruce Gillis, CEO of EpicGenetics

Presently, it is a diagnosis of exclusion. Patients end up spending, according to what’s been published in the medical literature, as many as 3 - 5 years going from doctor to doctor seeking a diagnosis because they tend to have nonspecific symptoms of a subjective nature.

23 Jul 2013

Novaliq receives CE mark approval for EyeSol technology

Novaliq GmbH, a drug delivery company with a focus on the topical application of ophthalmic technologies for poorly soluble drugs, today announced the successful CE mark approval for the first topical eye lubricant based on Novaliq's proprietary technology EyeSol.

23 Jul 2013

Results of post-mortem brain tissue study using Navidea's NAV4694 imaging agent presented at AAIC 2013

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that researchers at McGill Center for Studies in Aging, Douglas Research Institute and Montreal Neurological Institute presented results of a post-mortem brain tissue study using Navidea's investigational Fluorine-18 labeled β-amyloid imaging agent, NAV4694, during the Alzheimer's Association International Conference in Boston, MA.

23 Jul 2013

Great Lakes NeuroTechnologies receives patent for Parkinson’s disease monitoring technology

Great Lakes NeuroTechnologies announced today they have received allowance of claims from the U.S. Patent Office for an application covering their system and method of stimulating the brain during sleep to treat movement disorder symptoms.

22 Jul 2013

Fujikura to exercise option to license Cellmid’s midkine diagnostic technology

Cellmid Limited has received confirmation that Fujikura Kasei Co Ltd (Fujikura) will exercise its Option to licence the midkine (MK) diagnostic technology by paying the requisite JPY40 million (AUD 440,000) Milestone Fee.

22 Jul 2013

HistoGenetics selects MiSeq sequencing system from Illumina for use in CLIA laboratory

Illumina, Inc. today announced that HistoGenetics, the leader in high-resolution sequence-based human leukocyte antigen testing services, has selected the MiSeq sequencing system for use in its CLIA laboratory.

From Illumina, Inc. 22 Jul 2013

Plague detection through anti-carbohydrate antibodies could lead to rapid diagnosis

Even today, the lives of humans and animals are claimed by plague. A new antibody-based detection method can be used to reliably and sensitively identify plague in patient serum and other biological samples.

18 Jul 2013

Quest Diagnostics completes sale of ibrutinib commercialization rights to Royalty Pharma

Quest Diagnostics Incorporated, the world's leading provider of diagnostic information services, announced today that it has completed the sale of its rights to royalties from commercialization of the drug candidate ibrutinib to Royalty Pharma, the industry leader in acquiring royalty interests in marketed and late stage biopharmaceutical products, for $485 million in cash.

From Quest Diagnostics 18 Jul 2013

Scientists develop iKnife that helps surgeons identify cancerous tissues

Scientists have developed an "intelligent knife" that can tell surgeons immediately whether the tissue they are cutting is cancerous or not.

18 Jul 2013

Breast cancer pilot study: Patients benefit from treatments guided by molecular profiling

The Side-Out Foundation's breast cancer pilot study, led by the Translational Genomics Research Institute, Translational Drug Development and Scottsdale Healthcare, has shown that cancer patients do better when their treatment is guided by molecular profiling.

18 Jul 2013

U.S. News & World Report ranks UC San Diego Health System among nation’s best hospitals

UC San Diego Health System is once again ranked among the nation's best in U.S. News & World Report's 2013-14 "America's Best Hospitals" issue. The magazine placed UC San Diego Health System #1 in the San Diego metropolitan area with national rankings in 10 specialties—placing it among the country's most prestigious institutions.

17 Jul 2013

Scientists develop histology expression predictor for most common types of lung cancer

Knowing what type of lung cancer a patient has is critical to determine which drug will work best and which therapies are safest in the era of personalized medicine. Key to making that judgment is an adequate tumor specimen for the pathologist to determine the tumor's histology, a molecular description of a tumor based on the appearance of cells under a microscope.

17 Jul 2013

GE Healthcare receives CE marking for breast tomosynthesis solution

GE Healthcare, hailed a new era for breast imaging today as it announced CE marking for SenoClaire, GE's new generation of breast tomosynthesis solution designed with a three-dimensional imaging technology.

16 Jul 2013

Zecotek partners with Hamamatsu to commercialize existing imaging technologies

Zecotek Photonics Inc., a developer of leading-edge photonics technologies for medical, industrial and scientific markets, today announced that its wholly owned subsidiary Zecotek Imaging Systems Pte. Ltd. has signed a joint collaboration partnership agreement with Hamamatsu Photonics (Tokyo: 6965) of Japan to commercialize existing imaging technologies and to collaborate on the upgrade and manufacture of photo detectors, integrated detector modules (IDM) and associated electronics and data acquisition modules for the imaging markets at large.

16 Jul 2013

FDA approves Gilotrif for patients with late stage non-small cell lung cancer

Companion test also approved to identify appropriate patients The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related death among men and women.

16 Jul 2013

Cambridge Epigenetix introduces TrueMethyl kits for epigenetics industry

Cambridge Epigenetix Ltd., a spin out biosciences company, has announced the launch of its TrueMethyl kits.

15 Jul 2013

Diagnostics News and Research

GSD receives FDA Clearance for 25-OH Vitamin D Total ELISA test

Bruker introduces AVANCE-IVDr platform for NMR clinical research and screening

Digital versions of standard molecular biology tool to detect common tumor-associated mutation in CSF

Cepheid, American Lung Association partner to promote TB awareness in U.S.

Fibromyalgia diagnosis: an interview with Dr. Bruce Gillis, CEO of EpicGenetics

Novaliq receives CE mark approval for EyeSol technology

Results of post-mortem brain tissue study using Navidea's NAV4694 imaging agent presented at AAIC 2013

Great Lakes NeuroTechnologies receives patent for Parkinson’s disease monitoring technology

Fujikura to exercise option to license Cellmid’s midkine diagnostic technology

HistoGenetics selects MiSeq sequencing system from Illumina for use in CLIA laboratory

Plague detection through anti-carbohydrate antibodies could lead to rapid diagnosis

Quest Diagnostics completes sale of ibrutinib commercialization rights to Royalty Pharma

Scientists develop iKnife that helps surgeons identify cancerous tissues

Breast cancer pilot study: Patients benefit from treatments guided by molecular profiling

U.S. News & World Report ranks UC San Diego Health System among nation’s best hospitals

Scientists develop histology expression predictor for most common types of lung cancer

GE Healthcare receives CE marking for breast tomosynthesis solution

Zecotek partners with Hamamatsu to commercialize existing imaging technologies

FDA approves Gilotrif for patients with late stage non-small cell lung cancer

Cambridge Epigenetix introduces TrueMethyl kits for epigenetics industry

Event guide: 16th Clinical Biomarkers & CDx Summit Europe eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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