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Merck-Chimie to commercialize CardioGenics' proprietary paramagnetic beads

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced that CardioGenics Inc. and Merck Chimie S.A.S. have agreed on a plan to commercialize CardioGenics' proprietary paramagnetic beads, with shipments to Merck-Chimie's customers scheduled to start mid-September 2010.

4 Aug 2010

IRIS International closes AlliedPath acquisition

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that it has closed the acquisition of AlliedPath, Inc., a private, early stage high complexity, CLIA-certified laboratory focused on oncology and molecular diagnostics.

2 Aug 2010

Affymetrix second-quarter total revenue decreases to $71.7 million

Affymetrix, Inc., today reported its operating results for the second quarter of 2010. Total revenue for the quarter was $71.7 million, in line with previously announced expectations, as compared to total revenue of $81.6 million in the second quarter of 2009.

22 Jul 2010

DermaGenoma announces availability of PsoriasisDX Genetic Test as CE Marked product for PsA

Molecular dermatology research and development innovator DermaGenoma, Inc. today announced that the PsoriasisDX Genetic Test for Psoriatic Arthritis is now available as a CE Marked product under the European In Vitro Diagnostic Directive.

21 Jul 2010

Corgenix, ELITech establish broad strategic alliance

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, and the ELITech Group, a Paris, France-based, privately held group of companies and worldwide manufacturer and distributor of in-vitro diagnostic equipment and reagents, today announced a broad strategic alliance.

19 Jul 2010

CardioGenics Holdings' subsidiary signs second product agreement with Merck Chimie

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced that the Company's subsidiary, CardioGenics Inc., has entered into an agreement with Merck Chimie S.A.S. to adopt its proprietary biological-linking technology to Merck-supplied magnetic beads designed to increase yields in antibody manufacturing.

15 Jul 2010

Accuri Cytometers announces completion of $6 million Series E preferred stock financing

Accuri Cytometers, Inc., a world leader in providing life science researchers with easy-to-use, cost-effective flow cytometers, today announced completion of a $6 million Series E preferred stock financing. The financing included current investors Arboretum Ventures, Baird Venture Partners, Fidelity Biosciences, Flagship Ventures and the InvestMichigan! Program co-managed by Credit Suisse.

12 Jul 2010

IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that its IRIS Diagnostics Division submitted on June 30, 2010, a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its iChem®Velocity™ Automated Urine Chemistry Analyzer and iRICELL® Urinalysis Workstation.

1 Jul 2010

Signature Dx obtains worldwide license to Affymetrix microarray technology for development of CRC tests

Affymetrix, Inc. and Signature Diagnostics AG today announced that they have signed a Powered by Affymetrix™ (PbA) agreement. Under the agreement, Signature Dx obtains a worldwide license to use Affymetrix® microarray technology to develop and commercialize diagnostic and prognostic colorectal cancer (CRC) tests.

29 Jun 2010

AMP comments on barriers to market for molecular diagnostic tests at FDA CDRH meeting

Yesterday, the Association for Molecular Pathology (AMP) gave public comments at the FDA's Center for Devices and Radiological Health (CDRH) Council meeting on Medical Device Innovation: Barriers to Market for Molecular Diagnostic Tests.

28 Jun 2010

CardioGenics announces clinical test sites for QL Care portable blood analyzer

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care (POC) analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced the selection of four sites for clinical testing of its patented QL Care™ Analyzer, a portable diagnostic platform designed to produce test results with central lab-like accuracy in 15 minutes using whole blood.

21 Jun 2010

CardioGenics Holdings files Certificate of Change with the Secretary of State of Nevada

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced today that the Company has filed a Certificate of Change with the Secretary of State of Nevada, which implements a share consolidation of the Company's authorized and outstanding common stock on a ten (old) for one (new) basis.

19 Jun 2010

FDA seeks public input on regulation of laboratory-developed tests

The U.S. Food and Drug Administration today announced plans to hold a public meeting on July 19-20, 2010, to discuss how the agency will oversee laboratory-developed tests (LDTs).

17 Jun 2010

Bayer receives silver Medical Design Excellence Award for CONTOUR USB blood glucose meter

Bayer's CONTOUR® USB meter, the first blood glucose monitor with unique plug & play diabetes management software, today received a silver Medical Design Excellence Award (MDEA). The MDEA recognizes excellence in medical product design and manufacturing. The independent judges for the prestigious award, sponsored by the specialist journal Medical Device and Diagnostic Industry, acknowledged the great innovative power and particularly user-friendly operation of Bayer's CONTOUR USB meter.

10 Jun 2010

SFDA approves China Medical Technologies' SPR-based HPV-DNA chip

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced that it has received approval for its SPR-based HPV-DNA chip from the State Food and Drug Administration of China (the "SFDA").

10 Jun 2010

QuantRx Biomedical completes clinical testing of Q-Reader thyroid testing system

QuantRx Biomedical Corporation, a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, today announced that it has completed clinical testing of the Q-Reader thyroid testing system.

9 Jun 2010

China Medical Technologies fourth-quarter revenues down 29.3% to $25.7 million

China Medical Technologies, Inc., a leading China-based advanced in-vitro diagnostic company, today announced its unaudited financial results for the fourth fiscal quarter and the full fiscal year ended March 31, 2010.

4 Jun 2010

CardioGenics Holdings announces further update on status of its agreement with Merck Chimie

CardioGenics Holdings Inc., developer of the ultra-sensitive QL Care™ Point-Of-Care analyzer and products for the immunoassay segment of the In-Vitro Diagnostics market, announced today a further update regarding the status of its agreement with Merck Chimie S.A.S., one of the largest manufacturers and distributors of magnetic beads for the diagnostics market.

28 May 2010

Berman Institute experts available for comment on direct-to-consumer marketing of genetic test kits

Journalists covering the recent announcement by Pathway Genomics that it will sell health-related genetic marker tests to consumers—and the subsequent decision by Walgreens to postpone sales of the kits pending clarification of their legal status—are invited to interview Berman Institute experts Joan Scott or Gail Javitt.

17 May 2010

IVAX Diagnostics first-quarter net revenues decline 1.4% to $4,655,000

IVAX Diagnostics, Inc., a fully integrated in vitro diagnostics company, reports its financial results for the quarter ended March 31, 2010.

14 May 2010