Provista Diagnostics announces first patient enrolled in study of breast cancer test - Medical Devices Business Review
Provista Diagnostics has announced that the first patient has been enrolled in the company's 500-patient prospective study of an advanced version of its proteomic breast cancer assay.
Source : invitrodiagnostics.medicaldevices-business-review.com
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Quidel Gets De Novo FDA Clearance for Combined HSV, VZV Assay | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
Quidel said today that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct HSV 1+2/VZV multiplex real-time assay.
Source : genomeweb.com
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Beckman Coulter Presents The New Veris Mdx Molecular Diagnostics System
The system offers automated nucleic acid extraction, purification, amplification, and detection. It accepts several sample containers for plasma, serum and culture tubes. 48 samples can be lined up on 12 racks of 4 samples each. The time to result for DNA tests is around 70 minutes and for RNA tests a little longer, around 100 minutes, because PCR amplification only works on DNA and therefore you must reverse-transcribe to cDNA first. For multiplex analysis five different detection colors available with a bandwidth of 505 to 720 nm. The onboard capacity consists of 96 extraction and purification cartridges and reagents are covered for 20 assays with 48 tests per assay. Reagents are stable in the machine for up to 14 days.
Source : moveyourlabforward.com
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Idera, Abbott to develop companion diagnostic for B-cell lymphoma - Medical Devices Business Review
US-based Idera Pharmaceuticals and Abbott have entered into an agreement to develop an in-vitro companion diagnostic test for use in Idera's clinical
Source : invitrodiagnostics.medicaldevices-business-review.com
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Apple on medical tech hiring spree, a possible hint of iWatch plans
SAN FRANCISCO (Reuters) - Apple Inc is building a team of senior medical technology executives, raising hackles in the biotechnology community and offering a hint of what the iPhone maker may be planning for its widely expected iWatch and other wearable technology....Much of the hiring is in sensor technology...
Source : reuters.com
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bioMérieux: feu vert aux Etats-Unis pour un nouveau test gastro-instestinal
Le groupe de diagnostic in vitro bioMérieux a annoncé lundi avoir obtenu le feu vert de l'agence américaine du médicament (FDA) pour la mise sur le marché aux Etats-Unis de son nouveau test gastro-intestinal FilmArray, développé par la société BioFire Diagnostics. FilmArray est un système de diagnostic moléculaire qui permet d'identifier en un seul réactif les pathogènes, d'origine virale ou bactérienne, responsables d'une infection gastro-intestinale.
Source : leparisien.fr
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BaseHealth launches a wellness platform that melds genomics and devices
A startup called BaseHealth launched on Tuesday with a mission to deliver personalized wellness plans while keeping doctors very much in the picture. The company’s platform combines genetic data, lifestyle data and medical records to determine patients’ risks and how they can mitigate them.
Source : gigaom.com
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The diagnostics market for infectious diseases such as tuberculosis, human immunodeficiency virus, Hepatitis C virus, and human papilloma virus is...
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Corporate site - GENSIGNIA :: MicroRNA Diagnostics for Lung Cancer
GENSIGNIAGENSIGNIA :: novel diagnostic clinical tests for earlier and more accurate early detection of lung cancer
Source : gensignia.com
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PerkinElmer to Shutter Signature Genomics Business | GenomeWeb Daily News | Arrays | GenomeWeb
PerkinElmer has decided to close its Signature Genomics cytogenetic testing services business. A company spokesperson told GenomeWeb Daily News that effective May 2, PerkinElmer is "exiting its microarray service business, Signature Genomics, which provides diagnostic genetic testing services using microarrays." PerkinElmer cited "changing market conditions, including a highly unfavorable reimbursement environment, combined with a significant decline in demand for invasive procedures due to the uptake of non-invasive prenatal testing" as reasons for its decision.
Source : genomeweb.com
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La France élabore actuellement sa nouvelle Stratégie nationale de recherche (SNR) qui fixe les axes prioritaires de recherche pour les années à venir. Cette feuille de route politique marche dans les clous du nouveau programme-cadre européen Horizon 2020. En France, des ateliers de réflexion ont planché sur dix grands défis sociétaux, avec à l’esprit la nécessité d’un transfert plus important et rapide vers l’innovation....La recherche en biologie s’y trouve réduite au défi « santé et bien-être ». Si nul ne doute que la recherche biomédicale a vocation à améliorer ces deux domaines, on peut s’interroger sur la pertinence des priorités identifiées par la SNR pour atteindre ces objectifs....
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dmdPost - Autodiagnostic : quand les smartphones se substituent aux laboratoires d'analyse
Les smartphones vont occuper une place importante pour la réalisation de diagnostics médicaux à domicile, sans passer par un laboratoire. One Drop Dia...
Source : dmdpost.com
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Can a device that began life as hairdryer parts in a shoebox really bring countries one step closer to malaria eradication? Linda Nordling investigates
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Point-of-Care Tests for Anemia - Labcompare
Total hemoglobin concentration is said to be the most common laboratory test ordered in medical offices and hospital settings. It is used to determine the presence of anemia, functionally defined as insufficient oxygen-carrying capacity of the blood. In keeping with the trend of incorporating sophisticated technology into easily used point-of-care devices, many manufacturers provide products that offer prompt assessment of hemoglobin levels. Point-of-care hemoglobin testing is being increasingly used to provide rapid results in many clinical settings, including the perioperative setting, where it enables rapid decision-making for administering red blood cell transfusions.
Source : labcompare.com
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Enigma Diagnostics, China ICDC to Collaborate on Pathogen Dx | GenomeWeb Daily News | PCR/Sample Prep | GenomeWeb
Enigma Diagnostics today said that it will collaborate with China’s National Institute for Communicable Disease Control and Prevention on the development of rapid molecular diagnostics for infectious disease pathogens...The collaboration is a cornerstone achievement in our China strategy and our broader commercialisation programme and follows on from the European CE mark registration of the Enigma ML system in January this year.
Source : genomeweb.com
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NanoString Technologies Inc. Receives Canadian Market Approval For Its Prosigna Breast Cancer Prognostic Gene Signature Assay
Source : devicespace.com
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QIAGEN receives FDA clearance for QIAsymphony RGQ MDx system - Medical Devices Business Review
QIAGEN has announced that its artus C. difficile QS-RGQ MDx Kit has been cleared by the US Food and Drug Administration (FDA) to qualitatively detect Clostridium difficile, a widespread healthcare-associated infection (HAI).
In addition, the FDA has granted 510(k) regulatory clearance for the QIAsymphony RGQ MDx system, QIAGEN's flagship automation platform that is transforming laboratory workflows and driving dissemination of molecular diagnostics.
Source : invitrodiagnostics.medicaldevices-business-review.com
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BioMerieux's GI Panel Cleared by FDA | GenomeWeb Daily News | PCR/Sample Prep | GenomeWeb
BioMérieux today announced that BioFire's FilmArray Gastrointestinal Panel has received 510(k) clearance for marketing by the US Food and Drug Administration. The 22-target panel is for diagnosing infectious diarrhea and includes bacteria, viruses, and parasites in one test. According to BioMérieux, the test is the most comprehensive gastrointestinal panel to be cleared by FDA and contains several pathogens that have received FDA clearance for the first time...
Source : genomeweb.com
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The County Antrim-based healthcare diagnostics company, Randox, announces a significant expansion after acquiring a laboratory in Manchester.
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RayBiotech Partners With Xcellcure Inc To Develop
NORCROSS, GA-- - RayBiotech, Inc. announced today that it has partnered with XCellCure, LLC to develop a proprietary cardiovascular disease diagnostic kit
Source : devicespace.com
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Diaxonhit a annoncé l'obtention d'une aide financière de 1 728 000 euros de Bpifrance, dans le cadre de sa participation au consortium de recherche mené par InnaVirVax et financé sous l'égide du programme « Innovation Stratégique Industrielle ».
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Hologic's Tepnel Gains CSP Status for Ion Torrent PGM | GenomeWeb Daily News | Sequencing | GenomeWeb
Hologic today announced that its subsidiary Tepnel Pharma Services achieved customer service provider status in Life Technologies' Ion Torrent Service Provider program on the Ion Personal Genome Machine platform.
Source : genomeweb.com
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Sandia scientists create fertility test for men
Two former Sandia National Laboratories scientists say they have come up with a take-home fertility test for men.... They say the test could be available to consumers as early as 2015.
Source : lcsun-news.com
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Response Genetics has entered an exclusive commercial agreement with the Knight Diagnostic Laboratories, part of the Knight Cancer Institute at...
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Cancer du col de l'utérus: un test de Roche autorisé aux Etats-Unis - Le Parisien
Cancer du col de l'utérus: un test de Roche autorisé aux Etats-Unis : l'autorité américaine de la santé (FDA) a autorisé le test Cobas HPV du groupe suisse Roche Diagnostics comme test de premier choix pour la détection du cancer du col de l'utérus.
Source : leparisien.fr
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