Immunoassay News and Research

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Health Canada approves Meridian Bioscience's illumigene C. difficile molecular amplification assay

Meridian Bioscience, Inc., today announced that it has received an approved medical device license from Health Canada for its new molecular amplification assay, illumigene C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

1 Oct 2010

Quidel receives FDA clearance for QuickVue RSV 10 immunoassay test

Quidel Corporation, a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its QuickVue RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.

29 Sep 2010

Scientists develop NIA assay to determine drug's differential effects in tumor cells

A novel technology can make nanoscale protein measurements, which scientists can use in clinical trials to learn how drugs work.We are making progress toward the goal of understanding how drugs work in different individuals, said Alice C. Fan, M.D., instructor in the division of oncology at Stanford University School of Medicine.

29 Sep 2010

Scientists discover simple molecular test to block GOAT enzyme

Scientists at The Scripps Research Institute have designed a new molecular test that will allow researchers to look for potential drugs targeting a human metabolic enzyme believed to stimulate the appetite and play a role in diabetes.

17 Sep 2010

Roche Diagnostics introduces STAT immunoassays for cardiac biomarker testing

Roche Diagnostics announced today that it has introduced a complete battery of STAT immunoassays for cardiac biomarker testing on the cobas 6000 analyzer series, an integrated system designed for diagnostic labs with medium testing volumes.

From Roche Sequencing and Life Science 17 Sep 2010

CaPre drug candidate shows promising result on CRP level reduction

Acasti Pharma Inc., a subsidiary of Neptune Technologies & Bioressources Inc. reports significant results on the effects of its anti-dyslipidemic investigational drug candidate CaPre on C-reactive protein (CRP) levels, a biomarker of CardioVascular Disease risk (CVD) and associated with diabetes and obesity.

3 Sep 2010

Quidel's RapidVue hCG lateral flow pregnancy immunoassay granted FDA 510(k) clearance

Quidel Corporation, a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).

2 Sep 2010

CardioGenics Holdings receives 'Outperform' investment rating from Zacks

Zacks Equity Research initiated research coverage on CardioGenics Holdings Inc. with a six-month target price of $1.22 per share.

24 Aug 2010

Beckman Coulter announces contract with CML for high quality diagnostic services

Beckman Coulter, Inc., a leading developer, manufacturer, and marketer of products that simplify, automate, and innovate complex biomedical testing, today announced a record contract with CML HealthCare of Toronto, Canada. According to the company, the deal represents the largest contract of any Canadian diagnostics company for a single testing site.

From Beckman Coulter Diagnostics 5 Aug 2010

Merck-Chimie to commercialize CardioGenics' proprietary paramagnetic beads

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced that CardioGenics Inc. and Merck Chimie S.A.S. have agreed on a plan to commercialize CardioGenics' proprietary paramagnetic beads, with shipments to Merck-Chimie's customers scheduled to start mid-September 2010.

4 Aug 2010

IRIS International closes AlliedPath acquisition

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that it has closed the acquisition of AlliedPath, Inc., a private, early stage high complexity, CLIA-certified laboratory focused on oncology and molecular diagnostics.

2 Aug 2010

Roche to present diagnostics testing solutions at 2010 Clinical Lab Expo

Roche is featuring a diverse portfolio of diagnostics testing solutions for healthcare professionals in booth #2808 at the AACC/CSCC 2010 Clinical Lab Expo here, July 27-29 – and it's giving them a unique way to see firsthand where their own "dream lab" might take them.

From Roche Sequencing and Life Science 28 Jul 2010

CardioGenics Holdings' subsidiary signs second product agreement with Merck Chimie

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced that the Company's subsidiary, CardioGenics Inc., has entered into an agreement with Merck Chimie S.A.S. to adopt its proprietary biological-linking technology to Merck-supplied magnetic beads designed to increase yields in antibody manufacturing.

15 Jul 2010

FDA clears Meridian Bioscience's new illumigene C. difficile molecular amplification assay

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its new molecular amplification assay, illumigene™ C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

14 Jul 2010

USPTO grants Vermillion Alzheimer's disease biomarker patent

Vermillion, Inc., a molecular diagnostics company, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance of a patent entitled "Biomarkers for Alzheimer's disease" to the Company.

29 Jun 2010

Claros point-of-care system for PSA receives European CE Mark approval

Claros Diagnostics, a developer of novel point-of-care in vitro diagnostic systems, today announced the CE Mark approval for its rapid quantitative point-of-care diagnostic platform, which can now be used for prostate specific antigen (PSA) testing throughout the European Union. The approved system consists of a small portable analyzer and credit card-sized disposable.

29 Jun 2010

CardioGenics announces clinical test sites for QL Care portable blood analyzer

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced the selection of four sites for clinical testing of its patented QL Care™ Analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.

21 Jun 2010

FDA approves Abbott's ARCHITECT HIV Ag/Ab Combo assay

Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn't know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

21 Jun 2010

CardioGenics Holdings files Certificate of Change with the Secretary of State of Nevada

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced today that the Company has filed a Certificate of Change with the Secretary of State of Nevada, which implements a share consolidation of the Company's authorized and outstanding common stock on a ten (old) for one (new) basis.

19 Jun 2010

MicroConstants adds second Waters Xevo TQ MS system

MicroConstants, Inc., a bioanalytical and pharmacokinetic-specialty Contract Research Organization (CRO) in San Diego, California, announces the continued expansion of its bioanalytical capacity through the addition of a second Waters Xevo TQ MS system. The CRO has also appointed a new East Coast business development manager to actively pursue new business opportunities in that region.

10 Jun 2010