In Vitro Diagnostics News and Research

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IRIS International places 40 iQ200 Elite Automated Urine Microscopy Analyzers in Mexico in 2010

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory,has begun to significantly penetrate the Mexican healthcare market with the initial placement in 2010 of 40 iQ®200 Elite™ Automated Urine Microscopy Analyzers within one of the largest social security healthcare systems in Mexico.

25 Jan 2011

EDMA to endorse the campaign on Hypoparathyroidism

On the occasion of the World Hypoparathyroidism Awareness Day 2011, EDMA, the European Diagnostic Manufacturers Association, highlights the crucial role the In Vitro Diagnostic (IVD) industry can play to effectively testing this rare endocrine condition.

5 Jan 2011

IRIS ships 3,000th iQ200 Automated Urine Microscopy Analyzer to Sarasota Memorial Hospital

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, has shipped its 3,000th iQ200Automated Urine Microscopy Analyzer.

5 Jan 2011

Celera seeks FDA premarketing approval for KIF6 Genotyping Assay

Celera Corporation today announced that it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its KIF6 Genotyping Assay, a new molecular In Vitro diagnostic (IVD) test designed to detect a marker for risk of coronary heart disease (CHD) independent of traditional risk factors and aid clinical evaluation when statin treatment is being considered.

3 Jan 2011

FDA joins Abbott Diabetes Careto to recall 359 glucose test strips

The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patient's health.

22 Dec 2010

Researchers receive $100,000 NFL grant to study tissue engineering for spinal injuries

Researchers from Cornell University and Weill Cornell Medical College have been awarded $100,000 by NFL Charities, the charitable foundation of the National Football League owners, to research tissue engineering for spinal injuries.

22 Dec 2010

Spartan RX CYP2C19 DNA testing system receives European CE Mark certification

Spartan Bioscience Inc., a privately held molecular diagnostics company that develops, manufactures, and markets DNA testing systems for on-demand applications, today announced its Spartan RX CYP2C19 received a CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices. The CE Mark certification allows commercial distribution in Europe as well as in all countries recognizing the CE Mark in the Middle East, Africa, Latin America, and Asia-Pacific regions.

20 Dec 2010

GP Medical, Beijing Yuande named in Deloitte Technology Fast 500 Asia Pacific 2010 program

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that its wholly-owned subsidiaries, Beijing GP Medical Technologies Co., Ltd. and Beijing Yuande Bio-Medical Engineering Co., Ltd., have been ranked 12th and 415th, respectively, in the Deloitte Technology Fast 500 Asia Pacific 2010 program.

6 Dec 2010

APHP selects Bruker´s Biotyper as exclusive MALDI-TOF mass spectrometry for microbial identification

At the 30th Reunion Interdisciplinaire de Chimothérapie Anti-Infectieuse (RICAI), Bruker announces that the Assistance Publique Hôpitaux de Paris (APHP) has selected Bruker´s IVD MALDI Biotyper as their exclusive MALDI-TOF mass spectrometry-based microbial identification tool.

2 Dec 2010

China Medical Technologies prices $125 million convertible senior notes offering

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that it increased the size of its previously announced offering of convertible senior notes. On November 30, 2010, the Company priced US$125 million in aggregate principal amount of convertible senior notes due 2016 at an issue price of 100%. The transaction is expected to close on December 6, 2010, subject to satisfaction of various customary closing conditions.

1 Dec 2010

IRIS announces product acquisition from BioMicro Systems

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and a provider of high value personalized medicine products and testing services, announced today that it has acquired the assets of a multi-purpose, bench-top instrument platform for automating highly repetitive, manual laboratory protocols for (F)ISH (fluorescence in-situ hybridization) testing and other slide-based cytogenetic applications.

30 Nov 2010

China Medical second quarter revenue increases 21.5% to RMB201.8 million

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced its unaudited financial results for the second fiscal quarter ended September 30, 2010

17 Nov 2010

China Medical Technologies' EGFR PCR Assay for lung cancer targeted drugs receives Chinese SFDA approval

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that it has received approval for its real-time PCR-based Epidermal Growth Factor Receptor Assay (the "EGFR PCR Assay") for the use of lung cancer targeted drugs from the State Food and Drug Administration of China (the "SFDA").

10 Nov 2010

Idaho seeks FDA marketing clearance for FilmArray Respiratory Panel

Idaho Technology, Inc. (ITI) announced today that it has filed a submission with the U.S. Food and Drug Administration for 510(k) clearance to market its FilmArray Respiratory Panel (RP) as an in vitro diagnostic product for patients with symptoms of upper respiratory tract infection.

4 Nov 2010

Epigenomics presents data on Septin9 biomarker clinical study for colorectal cancer at UEGW

Epigenomics AG, the cancer diagnostics company, announced that new data obtained in a clinical study with the Company's proprietary Septin9 biomarker for the blood-based detection of colorectal cancer, were presented yesterday at the 18th United European Gastroenterology Week (UEGW) in Barcelona, Spain.

28 Oct 2010

IMD receives EPO patent for NADiA ultra-sensitive protein detection and cell phenotyping platform

IRIS International, Inc. a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, and a provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that Iris Molecular Diagnostics (IMD)has been granted Patent No. EP1842226B1 by the European Patent Office (EPO) covering aspects of IMD's NADiA ultra-sensitive protein detection and cell phenotyping platform, which can detect proteins in the femtogram (1 quadrillionth) per milliter range and phenotype single cells.

14 Oct 2010

Cancer cells utilize energy-rich intermediates of sugar metabolism: Research

Cancer research is facing a radical change of direction. Cancer cells do not obtain their energy from the breakdown of sugar to carbon dioxide and water, but from energy-rich intermediates of sugar metabolism instead.

6 Oct 2010

cobas TaqScreen DPX Test now available with CE Mark: Roche

Roche announced today that the cobas TaqScreen DPX Test for use on the cobas s 201 system is now available with the CE Mark. It is the first IVD test to offer complete coverage of all human genotypes of parvovirus B19 (B19V) and hepatitis A virus (HAV) in one assay.

5 Oct 2010

Scientia Advisors reviews growth in POC market

Rapid medical tests that can be analyzed in close proximity to patients in professional settings comprise the fastest growing segment of the global $37.5B in-vitro diagnostics industry, according to a new global review of the point-of-care (POC) diagnostics industry.

15 Sep 2010

Transgenomic expands EU distribution of SURVEYOR Scan K-RAS CE IVD mutation detection kit

Transgenomic, Inc. today announced that it completed the requirements for CE IVD labeling and has significantly expanded distribution of its SURVEYOR® Scan K-RAS mutation detection kit throughout most of the European Union. The SURVEYOR Scan K-RAS CE IVD kit is a member of Transgenomic's family of mutation detection kits, which features proprietary SURVEYOR endonuclease technology.

14 Sep 2010