Nicox Inc, la filiale américaine de Nicox, lance aux Etats-Unis le portefeuille RetnaGene™ de tests génétiques de Sequenom Laboratories en accès élargi.
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Le groupe allemand Merck KGaA vient de signer un accord de collaboration avec Sysmex Inostics, une société de diagnostic moléculaire, pour l’élaboration et la commercialisation d’un test sanguin du biomarqueur RAS pour les patients atteints de...
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FDA approves Qiagen's artus CMV RGQ MDx kit - Medical Devices Business Review
Qiagen has announced that its artus CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the US Food and Drug Administration (FDA) under a full premarket approval (PMA).
The test is the only FDA-approved PCR-based assay optimized for low- to mid-throughput testing of CMV. With a turn-around time of approximately three hours, the assay provides faster results than other PMA approved tests.
Source : invitrodiagnostics.medicaldevices-business-review.com
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RightBio Metrics Introduces New FDA Cleared Point-Of-Care Devices To Provide Safer, Cleaner And More Accurate Gastric pH Readings
PHOENIX, June 11, 2014 /PRNewswire/ -- RightBio Metrics, an emerging leader in advanced fluid measurement technologies, today announces the
Source : devicespace.com
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Quest Adds BioMerieux's BRAF Mutation Test to its Melanoma CDx Offerings | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
Quest Diagnostics announced today it will offer BioMérieux's BRAF mutation companion diagnostic for two of GlaxoSmithKline's molecularly targeted melanoma drugs, Tafinlar (dabrafenib) and Mekinist (trametinib).
Source : genomeweb.com
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B Braun Medical, CeGaT Launch US Company Offering NGS-based Dx Panels | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
B Braun Medical US and Tuebingen, Germany-based CeGaT today announced the launch of a US company offering next-generation sequencing-based diagnostics.
Source : genomeweb.com
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Roche announces acquisition of Genia Technologies - Medical Devices Business Review
F. Hoffmann-La Roche has acquired US-based Genia Technologies that is currently developing a single-molecule, semiconductor based, DNA sequencing platform using nanopore technology.
Source : invitrodiagnostics.medicaldevices-business-review.com
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Clearbridge BioMedics Launching ClearCell FX System for Capturing Circulating Tumor Cell
Being able to study and analyze the DNA of circulating tumor cells (CTCs) that took off from a primary tumor may help oncologists identify particular strains of cancer and therefore make more informed decisions on how to treat their patients. Moreover, researchers studying cancer can monitor the disease progression from its early stages, hopefully leading to new therapies that can halt the disease before it develops further. To help with that, Clearbridge BioMedics out of Singapore is finally launching to market its ClearCell FX System that’s capable of capturing CTCs from a whole blood sample, a difficult trick that’s compared to an extreme version of looking for a needle in a haystack.
Source : medgadget.com
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Medical Device and Diagnostics News Articles on Industry Topics - Devicespace
Australian biotechnology company Minomic International Limited will register its MiStat ELISA prostate cancer test for CE Mark approval in the latter part of 2014.
Achieving CE approval will be a key commercial milestone for the company, allowing it to sell and market its early detection diagnostic technology in the 33 member countries within the European Union (EU). All medical devices marketed in the EU have been required to have CE approval since 1998.
Source : devicespace.com
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L'alliance de la puce et de la médecine
Le britannique Christofer Toumazou développe des micro-puces d'analyse génétique. Ses inventions lui valent d'être nommé au Prix européen de l'Innovation.
Source : lesechos.fr
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Enigma Diagnostics and China's ICDC Announce Collaboration to Develop MDx Infectious Disease Assays on Enigma ML system for use at Point-of-Care... The Enigma ML's highly accurate and multiplex assay reporting capabilities enables testing for the widest range of DNA and RNA disease targets with a fast turnaround time. The unique features of the system offer a hybrid laboratory and stand-alone diagnostic testing platform, designed to be of use in developed and emerging healthcare programmes.
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CareDx to Buy Transplant Dx Firm ImmuMetrix | GenomeWeb Daily News | Sequencing | GenomeWeb
CareDx, formerly called XDx, said late Wednesday that it has reached an agreement to acquire transplant diagnostic company ImmuMetrix.
Source : genomeweb.com
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LabCorp announces availability of xTAG CYP2D6 genotype assay - Medical Devices Business Review
Laboratory Corporation of America (LabCorp) has announced that the xTAG CYP2D6 Kit v3 qualitative genotyping assay, which helps clinicians in determining strategies for therapeutics metabolized by the CYP2D6 gene product, is now available from Luminex.
Source : invitrodiagnostics.medicaldevices-business-review.com
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Cepheid Partners with AstraZeneca, GSK, Cubist to Develop Rapid Dx for Drug-Resistant Pathogens | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
Cepheid is collaborating with AstraZeneca, Cubist Pharmaceuticals, and GlaxoSmithKline to develop a rapid diagnostic test that can analyze multi-drug resistant pathogens and help doctors prescribe the most beneficial antibiotics for patients. Cepheid is currently developing the Xpert Carba-R test for assessing bacteria from rectal swab samples. The goal of the consortium is to enable the test to also analyze a variety of other biological samples, such as respiratory samples from pneumonia patients.
Source : genomeweb.com
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IntegraGen se prépare à révolutionner le diagnostic des cancers
Imaginer un outil logiciel qui permette aux cliniciens en cancérologie d'affiner leur diagnostic et de personnaliser le traitement de chaque patient, en fonction du profil génétique d'une tumeur. C'est le défi ambitieux du projet ICE (Interpretation of Clinica Exome) que lance aujourd'hui IntegraGen, le spécialiste français des tests de diagnostic moléculaire pour l'oncologie et l'autisme.
Source : lesechos.fr
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Sequenom has sold its Bioscience business for up-to-USD 35.8 million to Agena Bioscience, which said it plans to expand clinical...
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Canada Approves Roche's HPV Test as a First-line Cervical Cancer Screen | GenomeWeb Daily News | PCR/Sample Prep | GenomeWeb
Roche announced on Tuesday that Health Canada approved the cobas 4800 HPV Test as a first-line primary screening test for cervical cancer in women at least 25 years old.
Source : genomeweb.com
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With an independently developed next-generation DNA sequencer, Chinese scientists are aiming to challenge the dominance of international players in the world’s fastest growing genome sequencing market...A team of scientists from the Beijing Institute of Genomics and Zixin Pharmaceutical Industrial have designed a next-generation DNA sequencer with a longer read length than current imported equipment and is cheaper to make and operate, this article says. However, if it would eventually be used for clinical diagnoses, it would compete with other longer reading machines, such as sequencers from Ion Torrent and Pacific Biosciences.
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Roche acquires DNA sequencing firm for up to $350 million
ZURICH (Reuters) - Swiss drugmaker Roche said it was buying privately held U.S. gene-sequencing firm Genia Technologies for up to $350 million, securing access to a technology that should allow it to decipher human genes at a cheaper cost.
Source : reuters.com
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Qiagen, Lilly sign collaboration agreement to co-develop companion diagnostics - Medical Devices Business Review
Qiagen and Eli Lilly have signed an agreement to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers
Source : invitrodiagnostics.medicaldevices-business-review.com
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Yole Développement released its new, in-depth market research report – “Point of Care Testing 2014: Applications for Microfluidic Technologies.”
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PerkinElmer to Distribute Sebia Newborn Screening System | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
PerkinElmer has signed an agreement to serve as the exclusive global distributor for Sebia's Capillarys 2 Neonat Fast system for labs conducting newborn screening.
Source : genomeweb.com
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Qiagen wins U.S. approval for test to accompany Amgen cancer drug
FRANKFURT (Reuters) - U.S. health regulators on Friday approved Qiagen NV's gene-testing kit to identify those colorectal cancer patients most likely to benefit from Amgen Inc's drug, Vectibix, Qiagen
Source : reuters.com
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FDA Approves Immucor's Blood Compatibility MDx Test | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
The US Food and Drug Administration on Wednesday approved the Immucor Precise Type Human Erythrocyte Antigen Molecular BeadChip Test for determining blood compatibility. In a statement the FDA said the test is the first molecular assay to be approved by the agency for use in transfusion medicine to help in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD red blood cell types...
Source : genomeweb.com
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Qiagen Acquires Biobase Assets | GenomeWeb Daily News | Informatics | GenomeWeb
Qiagen has purchased the assets of Biobase, a Wolfenbüttel, Germany-based provider of curated biological databases.
Source : genomeweb.com
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