In Vitro Diagnostics News and Research

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SQI Diagnostics gets FDA clearance to market Celiac Panel in the US

SQI Diagnostics Inc. today announced that it has received notice that the United States Food and Drug Administration has cleared the Company to market its proprietary Celiac Panel in the United States (US).

8 Nov 2014

Sigma-Aldrich acquires Cell Marque

Sigma-Aldrich Corporation, a leading Life Science and High Technology company, announced it has completed its acquisition of Rocklin, California based Cell Marque Corporation, an industry-leading provider of in vitro diagnostic (IVD) antibody reagents and kits. The Company expects this acquisition to be neutral to mildly accretive to earnings per share in 2015. Terms of the transaction were not disclosed.

4 Nov 2014

GE Healthcare-Glaxo Smith Kline deal to create force in cancer testing

A recently announced deal between GE Healthcare-subsidiary Clarient and Glaxo Smith Kline will create a force in cancer testing, according to Kalorama Information. The healthcare market research publisher tracks companion products, and says that the two entities will form a multi-purpose, data analytics- and companion diagnostics-driven network of laboratories. Kalorama Information recently released a market study, Companion Diagnostics Market, for companion diagnostics such as the drug-test combinations envisioned in this deal.

9 Oct 2014

Sigma-Aldrich enters into agreement to acquire Cell Marque to better serve IHC customers

Sigma-Aldrich Corporation announced today that it has entered into an agreement to acquire Rocklin, California, based Cell Marque Corporation in a move to strengthen its antibody portfolio and to better serve immunohistochemistry (IHC) customers.

3 Oct 2014

Luminex gets FDA approval to add three new targets to xTAG Gastrointestinal Pathogen Panel

Luminex Corporation today announced it has received U.S. FDA clearance to add three new targets to its xTAG Gastrointestinal Pathogen Panel (GPP). The targets include Adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae.

From Luminex 30 Sep 2014

Lung-MAP, ALCHEMIST clinical trials offer innovative study designs for lung cancer patients

The recent launch of two clinical trials offer innovative study designs for patients with lung cancer. These clinical trials are the direct result of a National Cancer Institute sponsored workshop chaired by Drs. Fred R. Hirsch, Shakun Malik and Claudio Dansky- Ullman, that brought together the NCI Thoracic Malignancies Steering Committee, the US Food and Drug Administration, academicians, clinicians as well as industry and government stakeholders to discuss issues and challenges related to clinical trial design and biomarkers for lung cancer targeted-therapies.

29 Sep 2014

AIT, BioVendor and SCIENION partner to develop in-vitro diagnostic test for colon cancer

The AIT Austrian Institute of Technology, BioVendor and SCIENION today announced that the three companies will partner on the development of an in-vitro diagnostic test for colon cancer. The innovative test kit shall identify cancer at an early stage based on tumor autoantibody biomarkers.

24 Sep 2014

Sophia Genetics obtains CE-IVD mark for routine genetic tests

Sophia Genetics, the European leader in NGS data analysis, has received the CE-IVD mark for genetic testing of Familial Mediterranean Fever and Hypercholeteromia.

24 Sep 2014

BioLegend acquires shares of Covance Antibody Services

BioLegend, Inc. (BioLegend) acquired the shares of Covance Antibody Services Inc., a business unit of Covance, located in Dedham, Massachusetts, on August 29, 2014.

From BioLegend 2 Sep 2014

Cepheid releases Xpert Flu/RSV XC for accurate determination of Flu A, Flu B and RSV infection

Cepheid announced today the release of Xpert® Flu/RSV XC, an on-demand molecular test for rapid, accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection.

2 Sep 2014

Two fully automated molecular testing systems for blood and plasma donor screening launched by Roche

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of the cobas 6800/8800 Systems, two integrated and fully automated molecular testing systems for blood and plasma donor screening, in markets accepting the CE mark. The cobas 6800/8800 Systems offer the fastest time to results with the highest throughput available, along with the longest walk-away time, enabling laboratory staff to drive increased workflow efficiencies, while adapting to their ever-changing testing demands.

From Roche Sequencing and Life Science 2 Sep 2014

SeraCare Life Sciences announces launch of new ACCURUN 501 C. difficile Control

SeraCare Life Sciences, a provider of high-quality biological materials that help optimize diagnostic performance, reliability and repeatability across the IVD lifecycle, today announced the launch of its new ACCURUN 501 C. difficile Control – the company's first molecular control product targeting hospital acquired infections.

23 Aug 2014

Mindray net revenues increase 8.9% to $334.5 million in Q2 2014

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, announced today its selected unaudited financial results for the second quarter ended June 30, 2014.

From Mindray 12 Aug 2014

Bio-Techne revenue increases 16% to $92.5 million in fourth quarter 2014

Techne Corporation, (d/b/a Bio-Techne) today reported its financial results for the fourth quarter and full year ended June 30, 2014.

From ProteinSimple 11 Aug 2014

Multisorb to exhibit sorbent solutions at 2014 AACC Annual Meeting and Clinical Lab Expo

Multisorb Technologies is pleased to announce it will be exhibiting at the 2014 AACC Annual Meeting and Clinical Lab Expo, July 29-31, in Chicago, Illinois. This is the largest clinical lab expo, bringing together clinical chemistry and diagnostics presenters and exhibitors from around the world.

26 Jul 2014

EKF Diagnostics to highlight expanding product portfolio at AACC Clinical Lab Expo

EKF, will be highlighting its expanding product portfolio on its subsidiary Stanbio Laboratory’s booth #1933 at the AACC Clinical Lab Expo in Chicago, USA.

From EKF Diagnostics 24 Jul 2014

Eurofins Genomics, AmpTec sign co-marketing agreement for IVT-RNAs

Eurofins Genomics, international market leader in genomic services, and AmpTec, internationally recognized provider of RNA technology products, have agreed on non-exclusively co-marketing AmpTec's IVT-RNAs globally.

2 Jul 2014

Bruker receives CFDA clearance to market IVD MALDI Biotyper System in China

Bruker Corporation today announced that it has received clearance from the China Food and Drug Administration to market and sell its IVD MALDI Biotyper System as a medical device in China for the identification of microorganisms isolated from human specimens.

From Bruker 25 Jun 2014

Cepheid releases molecular test for detection of carbapenemase-producing Gram-negative bacteria

Cepheid today announced the release of Xpert® Carba-R, an on-demand molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria, to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices.

16 Jun 2014

AtomoRapid blood test device named Best in Show at 2014 MDEA program

Atomo Diagnostics' multi-award winning AtomoRapid™ HIV last night was awarded Best in Show, and the winner of the In Vitro Diagnostics Category, at the 17th Medical Design Excellence Awards (MDEA), held in New York.

12 Jun 2014