Immunoassay News and Research

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Affymetrix signs definitive agreement to acquire eBioscience

Affymetrix, Inc., today announced that it has signed a definitive agreement to acquire eBioscience, Inc., a privately-held San Diego, CA-based company with an industry-leading position in flow cytometry and immunoassay reagents for immunology and oncology research and diagnostics. Under the terms of the agreement, Affymetrix will acquire eBioscience for $330 million in cash subject to certain customary adjustments.

30 Nov 2011

FDA grants Premarket Approval for Roche's IgM antibody to hepatitis B core antigen assay

Roche announced today that the U.S. Food and Drug Administration granted Premarket Approval for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module of the cobas 6000 analyzer series for mid-volume laboratories.

From Roche Sequencing and Life Science 31 Oct 2011

Health Canada grants medical device licence to Gen-Probe's PANTHER system

Gen-Probe Incorporated announced today that Health Canada has granted the Company a medical device license for the PANTHER system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs.

23 Aug 2011

SDIX adds nine new polyclonal antibodies to IVD reagents portfolio

SDIX, a leading provider of In Vitro Diagnostic (IVD) reagents, announced the addition of nine new polyclonal antibodies to its product line for the IVD market while exhibiting at AACC last week.

3 Aug 2011

New investment to strengthen Clearbridge Accelerator's incubation platform

Clearbridge Accelerator announced today that it has received an investment from Tim Draper, a well-established venture capitalist based in the Silicon Valley.

2 Aug 2011

Study sheds light on the way antibodies distinguish between different 'biomarkers'

A new research paper sheds light on the way antibodies distinguish between different but closely related 'biomarkers' - proteins which reveal information about the condition of the human body.

15 Jul 2011

Avantra announces Rapid Assay Prototyping Service for researchers and clinicians

Avantra Biosciences, a leading innovator in protein diagnostics, announces a Rapid Assay Prototyping Service. Avantra's new service allows researchers to cost effectively accelerate their research efforts using custom designed biomarker assays developed on Avantra's proven QPDx BioChip platform.

6 Jun 2011

Gen-Probe seeks FDA regulatory clearance for PANTHER fully automated and integrated molecular testing system

Gen-Probe Incorporated announced today that the Company has filed a 510(k) application with the US Food and Drug Administration for its PANTHER system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs.

20 May 2011

GenturaDx completes external HSV 1&2 alpha studies for IDbox System

Molecular diagnostics company GenturaDx announces the completion of external HSV 1&2 alpha studies for its IDbox instrument and cassette-based tests. Conducted at an external CLIA laboratory, the study analyzed more than 130 samples, including more than 70 clinical specimens.

16 May 2011

FDA clears Meridian's new C. difficile immunoassay

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received clearance from the U.S. Food and Drug Administration for a new Clostridium difficile immunoassay named Premier C. difficile GDH.

11 May 2011

CESAR, Saladax begin patient enrollment in paclitaxel CEPAC-TDM trial for NSCLC

In collaboration with Saladax Biomedical, Inc., the Central European Society for Anticancer Drug Research announced today that enrollment has begun in the CEPAC-TDM trial of paclitaxel therapeutic drug management with subsequent pharmacokinetic-guided dose adjustment in patients being treated for advanced non-small cell lung cancer.

27 Apr 2011

Intrinsic Bioprobes launches mass spectrometry-based protein assays for in-vitro diagnostic testing

Intrinsic Bioprobes Inc. ("IBI") today announced the launch of its first mass spectrometry-based protein assays for in-vitro diagnostic testing. The assays for beta-2-microglobulin, cystatin C, and retinol binding protein are performed on IBI's MASSAY® platform at the CLIA-certified and College of American Pathology (CAP) accredited diagnostic laboratory of the Institute of Genomics Medicine, UMDNJ-New Jersey Medical School.

20 Apr 2011

Abbott submits ARCHITECT 25-OH Vitamin D assay application to FDA for clearance

According to a recent report from the U.S. Centers for Disease Control and Prevention, a third of Americans have vitamin D levels that are either inadequate or deficient. While many people know that vitamin D is necessary to help the body absorb calcium, which helps create strong bones and muscles, many don't know that insufficient levels of this important vitamin may lead to other health problems.

16 Apr 2011

Novel biomarker test accurately detects proteins secreted from asbestos-related tumors

Researchers investigating a novel biomarker test believe it is the most accurate yet in detecting proteins secreted from tumors caused by exposure to asbestos. Study results of this aptamer proteomic technology were presented at the AACR 102nd Annual Meeting 2011, held April 2-6.

4 Apr 2011

Axxora.com to distribute TGR's new ELISAONE technology assay reagents in the US and South America

TGR BioSciences, a leading global provider of advanced cell based assay technologies in the fields of cancer, kinase and GPCR research, is extremely pleased to announce a distribution partnership with Axxora.com of San Diego, CA, US, a leading online global market place resource for innovative and high quality Life Science research reagents.

4 Apr 2011

Enzo Life Sciences introduces ELISA system to detect SMN protein

Enzo Biochem, Inc. and the Spinal Muscular Atrophy Foundation today announced that Enzo's wholly owned subsidiary, Enzo Life Sciences Inc., has launched a unique immunoassay system which can be used for the identification and detection of Survival Motor Neuron protein.

16 Mar 2011

MabCure presents ovarian cancer diagnostic blood test study results at SGO meeting

Biotechnology company MabCure, Inc. is presenting the results of its recently completed study on the diagnosis of ovarian cancer utilizing its proprietary monoclonal antibodies at the annual meeting of the Society of Gynecological Oncologists.

9 Mar 2011

Roche receives DOD approval to provide remote service and support for its lab analyzers

Roche announced today that it has received approval from the U.S. Department of Defense to provide remote service and support for its lab analyzers at Womack Army Medical Center through the DOD's secure B2B gateway. Roche is the first in-vitro diagnostics manufacturer to be approved by the DOD for this remote access.

From Roche Sequencing and Life Science 24 Feb 2011

MedTrust, Avantra collaborate to develop molecular diagnostic assay for cancer care

MedTrust Online and Avantra Biosciences announced today a novel collaboration to involve clinicians in the earliest stages of molecular diagnostic assay development for Avantra Biosciences' revolutionary QPDx multiplex immunoassay system.

22 Feb 2011

U.S. FDA clears QMS Everolimus Immunoassay to prevent rejection in kidney transplants

The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants.

14 Feb 2011