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Randox's Acusera Immunoassay Speciality 1 quality control receives FDA clearance

In Q3 of 2013, Randox announced that the Food and Drug Administration has approved the company's Acusera Immunoassay Speciality 1 quality control for use in US laboratories.

From Randox Laboratories Ltd. 22 Jul 2014

Beckman announces national availability of Prostate Health Index

Beckman Coulter Diagnostics, a global leader in prostate cancer diagnostics, announces national availability of the Prostate Health Index (phi)*, a simple, non‐invasive blood test that is three times more specific in detecting prostate cancer1 than PSA (prostate‐specific antigen).

22 Jul 2014

Novel device uses smartphone to measure cortisol concentration in saliva

Researchers have developed a device that uses any smartphone to measure the cortisol concentration in saliva. The device was presented Tuesday, June 24, at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago.

25 Jun 2014

Ferring Pharmaceuticals, Roche partner to make personalised infertility treatment possible

Ferring Pharmaceuticals and Roche have announced a collaboration to combine diagnostic testing technology from Roche with Ferring's human cell line derived recombinant follicle-stimulating hormone (human rFSH), a gonadotrophin currently in phase III development.

24 Jun 2014

Newborn congenital adrenal hyperplasia screening justified

The Swedish neonatal screening programme successfully detected all cases of clinically classified salt-wasting congenital adrenal hyperplasia during a 26-year period, researchers report.

5 Jun 2014

Bio-Techne makes $10M equity investment in CyVek

Techne Corporation, d/b/a Bio-Techne, announced today that it has made a $10 million equity investment in CyVek, Inc. (CyVek), with a commitment to acquire CyVek if certain future milestones are met.

4 Apr 2014

American Bio Medica's net sales decrease 7.3% in fourth quarter 2013

American Bio Medica Corporation today announced financial results for the fourth quarter and year ended December 31, 2013.

From Medica Corporation 29 Mar 2014

Singulex signs agreement to co-develop the Sgx Clarity system with Tecan

Singulex, Inc., the developer and leading provider of Single Molecule Counting (SMC) technology for clinical diagnostics and scientific discovery, today announced an agreement to co-develop the Sgx Clarity system with Tecan, a leading global provider of laboratory automation instruments.

From Tecan 25 Mar 2014

Mindray's net revenues increase 16.5% to $368.4 million in fourth quarter 2013

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, announced today its selected unaudited financial results for the fourth quarter and full year ended December 31, 2013.

From Mindray 4 Mar 2014

New biomarker for stress in wild animals facing global climate change

Chemical analyses by neuroscientist Jerrold Meyer and colleagues at the University of Massachusetts Amherst are helping to establish hair cortisol concentration (HCC) as an important new biomarker for stress in wild animals facing global climate change.

25 Jan 2014

New Access Total βhCG (5th IS) assay from Beckman Coulter receives FDA clearance and is granted CE Mark for Europe

Aligned with its commitment to help move reproductive health management forward, Beckman Coulter Diagnostics has received clearance for its new Access Total βhCG (5th IS) assay from the U.S. Food and Drug Administration (FDA) 510(k), as well as being granted the CE Mark specifically for Europe.

16 Jan 2014

Meridian's TRU FLU assay gets FDA clearance for analytical sensitivity claim for avian Influenza H7N9 strain

Meridian Bioscience, Inc. today announced that the company's TRU FLU assay received FDA clearance for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. TRU FLU is a rapid immunoassay that detects influenza A and influenza B viruses in 15 minutes in human respiratory specimens.

10 Jan 2014

New range of recombinant Fab monoclonal antibodies launched by BBI Solutions at Medica 2013

BBI Solutions, a world leader in immunoassay development and contract manufacturing, recently launched its unique range of Recombinant Fab Monoclonal Antibodies at the American Association for Clinical Chemistry’s (AACC) Annual Meeting and Clinical Lab Expo, on July 28-August 31, 2013, in Houston, Texas.

19 Nov 2013

New 4th generation HIV assays now available to improve screening for HIV infection

Laboratory Corporation of America Holdings announced today the availability of a 4th generation HIV antigen/antibody combination assay and a new diagnostic algorithm that improves screening for HIV infection.

6 Nov 2013

Vitamin D Total assay for use on Access 2 and UniCel DxI immunoassay systems receives CE Mark

Beckman Coulter, Inc. announces the CE Mark approval of Access 25 (OH) Vitamin D Total assay for use on the Access 2 and UniCel DxI series of immunoassay systems. Offering enhanced performance, the new assay is an important addition to the company’s bone metabolism assay menu.

23 Oct 2013

SeraCare Life Sciences announces expansion of R&D facilities in Milford, Massachusetts

SeraCare Life Sciences, a manufacturer of life sciences tools, bulk plasma, and quality controls for diagnostic companies and clinical laboratories, announced an expansion of its research and manufacturing facilities at its Milford, Massachusetts headquarters.

21 Sep 2013

65 metabolites in urine simultaneously measured by clinical IEM-by-NMR screening study in Turkey

At the 12th International Congress of Inborn Errors of Metabolism (www.iciem2013.com), Bruker announces another milestone in the cost-effective use of NMR (nuclear magnetic resonance) spectroscopy screening as a clinical research tool for metabolic screening and small molecule in vitro diagnostics (IVD) research and validation.

4 Sep 2013

Companion diagnostics: an interview with Trevor Hawkins, SVP, Strategy, Innovation and Business Development for Siemens Healthcare Diagnostics

Companion diagnostics is critical in helping to pave the way for personalized medicine, in which the treatment is adapted and precisely tailored to the patient.

From Siemens Healthineers 27 Aug 2013

GE, UW scientists to develop new medical device for detecting infectious disease

You've heard of on-demand TV, now imagine on-demand medical diagnosis - anytime, anywhere in the world. Scientists at GE Global Research, the technology development arm of the General Electric Co. (NYSE: GE), are working with a team based at the University of Washington to develop a new medical device, the size of a pack of playing cards, that can detect infectious disease by way of a simple nasal swab, in less than an hour.

9 Aug 2013

Qualigen's FastPack Vitamin D Immunoassay receives FDA clearance

Qualigen, Inc., a privately owned company that provides rapid, easy to use, fully quantitative diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration for its FastPack Vitamin D Immunoassay for use on its proprietary FastPack System for the rapid determination of vitamin D status.

16 Jul 2013