In Vitro Diagnostics News and Research

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FDA approves new xTAG Cystic Fibrosis 39 Kit v2 from Luminex

Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new cystic fibrosis (CF) test: the xTAG® Cystic Fibrosis 39 Kit v2.

From Thermo Fisher Scientific Inc. 4 Sep 2009

IVD labeled staining reagents for manual and automated staining platforms from DBS

Diagnostic Biosystems (DBS), a specialty immunohistochemistry (IHC) reagent company, announces the availability of products for clinical use in the US.

27 Aug 2009

AMDL Diagnostics to focus on in vitro diagnostic cancer tests

AMDL Inc. (NYSE Alternext US: ADL), a US-based pharmaceutical company with major operations in China, announced the inauguration of AMDL Diagnostics Inc. (ADI), a new wholly-owned subsidiary that will focus on the research, development, manufacture and international sales of Onko-Sure(TM)-- AMDL's proprietary, regulatory approved in vitro diagnostic (IVD) cancer test.

21 Aug 2009

AMDL reports revenues of $3.2 million for second quarter of 2009

AMDL Inc., a US-based pharmaceutical company with major operations in China, today reported unaudited results and the filing of its Form 10-Q with the Securities and Exchange Commission ("SEC") for fiscal second quarter 2009.

19 Aug 2009

Embryonic stem cells used to create human sperm

Human sperm have been created using embryonic stem cells for the first time in a scientific development which will lead researchers to a better understanding of the causes of infertility.

9 Jul 2009

New NYP course: Surgical approaches to the skull base

The skull base is not just a simple platform for the brain but an anatomically intricate area with an array of connections necessary to the body's essential functions.

8 Mar 2009

Lab tests online to benefit Czech Republic

EDMA, the European Diagnostic Manufacturers Association is proud to announce that the multilingual website, Lab Tests Online is now also available in Czech. The website, an online encyclopaedia on laboratory testing and related conditions, has been developed in Czech by the Czech Society of Clinical Biochemistry, CSKB, in cooperation with the national and European Diagnostics industry associations, CZEDMA and EDMA.

14 Oct 2008

AMDL granted FDA clearance to market blood test for colorectal cancer

AMDL has announced that the US Food and Drug Administration (FDA) has issued a letter of substantial equivalence to an existing predicate device and granted clearance to market the AMDL-ELISA DR-70(R) (FDP) as a safe and effective blood test for monitoring patients who have been previously diagnosed with colorectal cancer (CRC).

7 Jul 2008

Slow growth rate found in overall prices in medical technology sector

AdvaMed, the Advanced Medical Technology Association, has released an important new study that demonstrates the slow rate in growth in overall prices in the highly competitive medical technology sector.

14 Feb 2008

Formal European launch of lab tests online

The formal European Launch of Lab Tests Online, the peer reviewed, patient-centred, non-commercial source of information on laboratory testing, will take place on Thursday, 31 January at La Bibliotheque Solvay in Brussels.

29 Jan 2008

SEBIA joins EDMA corporate membership

EDMA , the European Diagnostic Manufacturers Association welcomes SEBIA as new corporate affiliate, bringing the Association's overall membership up to 33 major IVD companies and 21 National Associations.

12 Dec 2007

Breakthrough innovation for high sensitivity TB and Malaria diagnostics

At this year's 39th World Forum for Medicine in Dusseldorf (MEDICA, November 14-17), Partec, a globally leading developer, manufacturer and provider of dedicated diagnostic solutions in the response to HIV/AIDS, Tuberculosis and Malaria is presenting a breakthrough innovation for high sensitivity TB and Malaria diagnostics in low- and middle-income countries.

15 Nov 2007

EDMA calls for empowering people with diabetes

Type 2 diabetes and its complications are frequently diagnosed too late and the complications are often detected only at the time of diagnosis, concludes the European Parliament in its 2006 Written Declaration on Diabetes.

14 Nov 2007

Roche makes offer to acquire Ventana Medical Systems

Roche will make a tender offer to acquire all outstanding shares of common stock of Ventana Medical Systems for $75.00 per share in cash, or an aggregate of approximately $3 billion on a fully diluted basis.

From Roche Sequencing and Life Science 26 Jun 2007

Roche and Transgene S.A. partner on HPV vaccine program

Roche and Transgene S.A. have announced that they have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from Transgene's therapeutic vaccine program against Human Papilloma Virus-mediated diseases.

11 Apr 2007

In Vitro diagnostic market in Europe

The latest estimates on the In Vitro Diagnostic (IVD) market in Europe, corresponding to the year 2005, are now available.

14 Jan 2007

EDMA welcomes 7 new members

EDMA, the European Diagnostic Manufacturers Association, enlarges its membership with six new companies: BioSystems SA, Diagnostica Stago, Innogenetics, Luminex Corporation, Orion Diagnostica and Tecan, and the Foundation for Innovative New Diagnostics (FIND).

9 Jan 2007

New treatment for lower back pain using patient's own stem cells

A University of Manchester researcher has developed a treatment for lower back pain using the patient's own stem cells, which could replace the use of strong painkillers or surgery that can cause debilitation, neither of which addresses the underlying cause.

From The University of Manchester 2 Dec 2006

New male contraceptive

Men and women have long been promised a male version of the female contraceptive pill. But the first new male contraceptive to market may not be hormonal at all.

8 May 2006

Analysis of the regulatory hurdles in European Diagnostics

In a move aimed at harmonising diagnostics regulations, the European parliament amended the medical devices directive (MDD) of 1993 to bring in the IVD directive (98/79/EC) in 1998.

6 Dec 2005