The predominant hormone human chorionic gonadotropin (hCG) variant in urine, hCG ? core fragment (hCG?cf), has been demonstrated to cause false-negative results in qualitative point-of-care (POC) hCG devices.
In a hospital setting, failure to detect pregnancy can lead to major consequences such as administration of medications that cause birth defects, fetal radiation exposure, or failure to diagnose ectopic pregnancy, which is the leading cause of first-trimester pregnancy-related maternal death...
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Acquisition will broaden product offering, providing an Asian operations centre.
Beckman Coulter Life Sciences has entered into an agreement to acquire Xitogen Technologies Inc. together with Cytojene Corporation. Xitogen, a flow cytometer developer based in Suzhou and Dalian, China, will provide Beckman Coulter Life Sciences with both a strong operational base in the growing China market and a high quality research instrument to round out their world-class cytometry offering.
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Roche and Hitachi have renewed their alliance in the diagnostics business by 10-years for the joint development and manufacture of...
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A new blood gas analyzer combines revolutionary microelectronics with maintenance cartridge technology for a smaller, faster, and less expensive critical care analyzer.
The Stat Profile Prime blood gas analyzer uses MicroSensor Card technology, which contains biosensors for acidity (pH), partial CO2 (PCO2), partial O2 (PO2), sodium (Na), potassium (K), ionized calcium (iCa), chloride (Cl), glucose, lactate, and hematocrit. The MicroSensor Card is automatically calibrated and is always ready to deliver a full 10-test profile in just 60 seconds...
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Decision Diagnostics Subsidiar
the manufacturer of the popular GenStrip™, the unique Green Glucose Test Strip, specifically designed to work with the Johnson & Johnson's LifeScan Ultra family of glucose testing meters, today announced that that the Company's subsidiary, Pharma Tech Solutions, Inc. has announced the acquisition of Genstrip from Shasta Technologies LLC, including the intellectual property, trademarks, the FDA cleared 510(k) and various public and private product registrations. Pharma Tech has re-registered as Device Manufacturer of Genstrip with the U.S. FDA.
Source : devicespace.com
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Fluxion Biosciences Introduces IsoFlux(TM) NGS Assay Kits For Circulating Biomarker Detection
SOUTH SAN FRANCISCO, Calif.----Fluxion Biosciences announced the introduction of a new series of assay kits design to enhance and complete the workflow for next-generation sequencing (NGS) using the IsoFlux System....
Source : devicespace.com
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Quidel Gets FDA Clearance for Multiplex Strep Assay | GenomeWeb Daily News | PCR/Sample Prep | GenomeWeb
Quidel said today that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct Strep multiplex real-time PCR assay. The new test detects and differentiates between pyogenic Group A and pyogenic C or G streptococcal throat infections.
Source : genomeweb.com
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Abbott Laboratories Wins FDA Approval For Diabetes
Abbott (NYSE: ABT) announced today that its new ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test which can aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). More than 25 million Americans are living with diabetes and several million remain undiagnosed. People with diabetes who can understand and manage their condition can prevent or delay health problems, which may lead to longer and healthier lives.
Source : devicespace.com
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Aveo, Biodesix Collaborate on Ficlatuzumab, VeriStrat Rx/Dx Development Program | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
Aveo Oncology and Biodesix announced today an agreement to develop Aveo's investigational non-small cell lung cancer drug ficlatuzumab alongside Biodesix's VeriStrat serum protein test as a companion diagnostic.
Source : genomeweb.com
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Bio-Rad Acquires Sequencing Technology Developer GnuBio | GenomeWeb Daily News | Sequencing | GenomeWeb
Bio-Rad Laboratories has purchased next-generation sequencing technology firm GnuBio for an undisclosed price in order to give it capabilities in the NGS space, especially for clinical applications, Bio-Rad said this week.
Source : genomeweb.com
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Le groupe Roche a annoncé lundi l’acquisition de l’américain IQuum, une entreprise spécialisée dans les solutions de diagnostic moléculaire pour une somme préliminaire de 275 millions de dollars, puis jusqu’à 175 millions supplémentaires selon la...
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Roche : acquiert IQuum pour renforcer son offre dans le domaine du diagnostic moléculaire
La gamme de produits unique d'IQuum va permettre à Roche d'accéder rapidement au segment du diagnostic moléculaire au point de soins...
Source : boursier.com
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Alors que débute l'édition 2014 du Sidaction, la ministre des Affaires sociales, Marisol Touraine, a annoncé dans un communiqué que les autotests de dépistage du VIH seront "disponibles à la fin de l’année en pharmacie."...
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FDA Approves Roche HPV Assay as First-Line Cervical Cancer Screening Method | GenomeWeb Daily News |
Roche said today that the US Food and Drug Administration has approved its cobas HPV test for use as a first-line primary screening test for cervical cancer in women ages 25 years and older.
Source : genomeweb.com
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EKF Diagnostics Acquires Selah Genomics and DiaSpect Medical - Molecular and Clinical Diagnostics News
Combined with the recent acquisition of Seperation Technology the purchases strengthen EKF’s product and services offering.
EKF Diagnostics announce that it has acquired Selah Genomics, Inc. and DiaSpect Medical AB. Sweden based DiaSpect manufactures desktop hemoglobin analyzers, whilst Selah, of South Carolina is a service provider that supplies molecular diagnostics tests for the development of personalized medicine.
Source : technologynetworks.com
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Luminex Corporation Announces Norovirus As A Launch Menu Assay For Its New Sample-To-Answer System, ARIES(TM)
Luminex Corporation today announced that norovirus will be the fourth assay in the launch menu for its new sample-to-answer system, ARIES. The assay is designed to test for both GI and GII genogroups in a single, easy-to-use cassette. The previously announced items in the five assay launch menu targeted for the ARIES system also include: Flu A&B/RSV, HSV 1&2, and Clostridium difficile (C. diff).
Source : devicespace.com
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FDA proposes program to speed approval of medical devices
(Reuters) - The U.S. Food and Drug Administration on Tuesday proposed speeding up medical device approvals for patients who have no other treatment options through a new program focused on earlier and more frequent interactions between companies and FDA staff.
Source : reuters.com
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Quest Diagnostics Inc. Completes Acquisition Of
Quest Diagnostics , the world's leading provider of diagnostic information services, has completed the previously announced acquisition of Summit Health, a leading provider of on-site prevention and wellness services.
Source : devicespace.com
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Can Fite BioPharma Initiates The Development Of An
Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today it has signed an agreement with Smart Assays to develop a commercial biomarker blood test kit for the A3 adenosine receptor (A3AR). Can-Fite's A3AR predictive biomarker kit is designed for use at any molecular biology lab prior to treatment to help identify an individual patient's responsiveness to the Company's drugs, thus providing personalized medicine.
Source : devicespace.com
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Is Illumina's $1,000 Genome a Realty? Not for Clinical Laboratory Purposes, Asserts an In Vitro Diagnostics Expert | Dark Daily
It was January when headlines nationwide trumpeted Illumina’s introduction of the $1,000 genome. The story “The $1,000 Genome Arrives—For Real, This Time,” was typical of much of the press coverage... ...it is important to know the real facts about the cost and performance of Illumina’s latest generation of genome sequencing technology...
Source : darkdaily.com
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Qiagen Licenses Blood Disorders Biomarker from CeMM Vienna | GenomeWeb Daily News | Clinical Genomics | GenomeWeb
Qiagen announced after the close of the market on Thursday that it has exclusively licensed a biomarker that it plans to use in a molecular diagnostic test for a group of blood disorders called myeloproliferative neoplasms.
Source : genomeweb.com
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QIAGEN ajoute un nouveau biomarqueur prometteur à son portefeuille de tests diagnostiques au service d’une meilleure prise en charge personnalisée des hémopathies - De nouveaux outils de diagnostic sont en cours de développement pour une identification fiable de mutations du gène calréticuline (CALR) et devraient bénéficier aux patients atteints de syndromes myéloprolifératifs
- QIAGEN dispose d’une licence mondiale exclusive acquise auprès du CeMM de Vienne pour le biomarqueur CALR, sur lequel une des équipes du CeMM a récemment publié dans le New England Journal of Medicine
- La position de leader de QIAGEN sur le marché du diagnostic dans la prise en charge personnalisée des syndromes myéloprolifératifs se voit renforcée par l’ajout de ce biomarqueur en complément des kits existants, notamment sur les biomarqueurs JAK2 et BCR-ABL
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Global in vitro diagnostics company EKF Diagnostics has acquired Separation Technology, manufacturer of IVD devices for hematology testing, complementing EKF’s existing offering in the hemoglobin testing market, which includes Hemo Control (also sold as HemoPoint H2 in USA and Asia).
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Roche Acquires POC MDx Firm Iquum | GenomeWeb Daily News | PCR/Sample Prep | GenomeWeb
Roche said today that it has acquired Iquum, a privately held company developing point-of-care molecular diagnostics.
Source : genomeweb.com
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IntegraGen, leader français des services en génomique, et spécialisé dans le développement de tests de diagnostic moléculaire pour l’oncologie et l’autisme, annonce aujourd’hui la signature d’un accord avec Pfizer Inc. qui permettra au groupe américain d’évaluer la signature moléculaire d’IntegraGen dans le carcinome hépatocellulaire. Cette évaluation doit permettre de vérifier la capacité des marqueurs génétiques de cette signature à correctement identifier le pronostic clinique des patients. La signature moléculaire, qui porte sur 56 gènes, permet également de catégoriser les patients en six groupes distincts, sur la base du profil moléculaire de leur tumeur du foie.
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