In Vitro Diagnostics News and Research

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China Medical Technologies first-quarter fiscal 2010 revenues decrease 10.9% to RMB186.2 million

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

16 Aug 2010

A*STAR's Singapore Immunology Network, Institut M-rieux and bioM-rieux partner in TB research

An investment of S$3 million is being pumped into tuberculosis (TB) research by A*STAR's Singapore Immunology Network (SIgN), bioindustrial group Institut M-rieux and its in vitro diagnostics company bioM-rieux. The project, which involves setting up a joint laboratory in Biopolis, Singapore aims to investigate and identify novel biomarkers that could allow early identification of individuals at risk of TB disease development and disease reactivation. This could lead to better diagnosis and treatment for the highly contagious disease.

13 Aug 2010

Transgenomic second-quarter net loss increases to $1.1 million

Transgenomic, Inc. today reported financial results for the three and six months ended June 30, 2010, and provided a business update.

13 Aug 2010

AdvanDx announces European launch of CE-IVD marked GNR Traffic Light PNA FISH test

AdvanDx today announced the launch of its CE-IVD marked GNR Traffic Light™ PNA FISH® test in Europe. GNR Traffic Light PNA FISH is the first-ever test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures in less than 90 minutes.

12 Aug 2010

GenMark second-quarter revenues increase 162% to $651,000

GenMark Diagnostics, Inc. today reported revenues of $651,000 for the quarter ending June 30, 2010, a 162% increase over second quarter 2009. Net loss for the second quarter was $5.1 million, or $0.60 per share, compared to a net loss of $4.3 million and $1.08 per share for the same period last year.

10 Aug 2010

Epitomics launches EP Clone Rabbit Monoclonal Antibodies

Epitomics, Inc., the rabbit monoclonal antibody company, announces today the launch of EP Clone™ Rabbit Monoclonal Antibodies and their detection systems for pathology applications. These diagnostic immunohistochemistry (IHC) products are manufactured by the In Vitro Diagnostic (IVD) Division of the Company. This new line of products are developed in compliance with regulation for IHC antibodies and detection systems in the United States, these products are manufactured under FDA's Quality System Regulation (21 CFR, Part 820).

9 Aug 2010

IL releases new HemosIL HIT-Ab(PF4-H) assay

Instrumentation Laboratory (IL) today announced the release of the new HemosIL HIT-Ab(PF4-H) assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in minutes, the HemosIL HIT-Ab(PF4-H) assay detects total immunoglobulin against Platelet Factor 4-Heparin complexes, the antibodies associated with the pathology of HIT.

4 Aug 2010

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