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Sophia Genetics obtains CE-IVD marking for BRCA1/2 testing solution

Sophia Genetics, the European leader in Data Driven Medicine, has today obtained CE-IVD marking for its solution to detect BRCA1/2 associated genetic variants in live tumours.

14 Jan 2015

QIAGEN's circulating tumor DNA test CE-IVD marked to assess genomic mutation NSCLC patients

QIAGEN announced today the CE-IVD marking of its novel liquid biopsy-based companion diagnostic that analyzes circulating nucleic acids obtained from blood samples to assess an important genomic mutation in patients with non-small cell lung cancer (NSCLC), the most common form of this cancer.

From QIAGEN Manchester Limited 12 Jan 2015

DiaCarta raises $8 million in Series A financing from BVCF

DiaCarta, Inc., a privately-held biotechnology company raised $8 million in Series A financing from BVCF (BioVeda China Fund). Proceeds from Series A financing will be used to expand the product portfolio and support global commercialization. Dr. Weixin Xu of BVCF will join DiaCarta board of directors.

9 Jan 2015

Proteomics market expected to experience continual growth

The market for microarrays used to study the workings of proteins are in great demand, according to Kalorama Information. The healthcare market research publisher said "proteomics" instruments, reagents and testing are needed to discover new biomarkers and even new drugs, and that the market for them topped 5 billion dollars in 2013.

8 Jan 2015

FDA provides Emergency Use Authorization for Roche's LightMix Ebola Zaire rRT-PCR Test

Roche today announced that the U.S. Food and Drug Administration has provided an Emergency Use Authorization (EUA) for the LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as individuals traveling from West Africa.

From Roche Sequencing and Life Science 30 Dec 2014

Sophia Genetics earns ISO 13485 and ISO 27001 certification for safe data handling and security

Sophia Genetics, the European leader in Clinical Genomics and Next Generation DNA Sequencing (NGS), has become the first company to achieve both ISO 13485 and ISO 27001 certification for its commitment to safe data handling and security.

16 Dec 2014

FDA takes immediate steps to help reduce risk of spreading unsuspected uterine cancer

The U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids, which is in keeping with Kalorama Information's view that in the female health market there is much room for improvement both in the development of products and the treatment of diseases.

29 Nov 2014

Synovasure PJI Alpha Defensin Test now available for sale in Europe

Zimmer today announced Synovasure PJI Alpha Defensin Test for Periprosthetic Joint Infection, the first and only test specifically designed for the diagnosis of Periprosthetic Joint Infection (PJI), is now eligible for sale in several European countries after earning key overseas certification this month.

19 Nov 2014

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