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BIDMC calls for new training program for personalized healthcare

The Department of Pathology at Beth Israel Deaconess Medical Center (BIDMC) have issued "A Call to Action" for the medical profession to catch up with the technology and business communities in the application of genomics to personalized health care.

2 Jul 2010

FIOCRUZ receives Brazil's Anvisa regulatory approval to market Chembio's Dual Path Platform HIV 1/2 rapid test

Chembio Diagnostics, Inc., which develops, manufactures, markets and licenses point-of-care diagnostic tests, has been notified that Bio-Manguinhos, a division of the Oswaldo Cruz Foundation of Brazil ("FIOCRUZ"), has received regulatory approval from Brazil's National Health Surveillance Agency (Anvisa) to market Chembio's Dual Path Platform (DPP®) HIV 1/2 rapid test for use with oral fluid, blood, serum or plasma samples. The approval triggers $400,000 in license revenues payable to Chembio within 120 days of the date of approval.

1 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

BioImagene, KUMC partner to develop Companion Algorithms for digital pathology

BioImagene, Inc., the leading provider of innovative digital pathology solutions, announced a collaboration with the University of Kansas Medical Center (KUMC) Department of Pathology & Laboratory Medicine to develop Companion Algorithms™ for next generation companion diagnostics for digital pathology.

1 Jul 2010

Roche, IBM announce agreement to develop nanopore-based sequencer for decoding human DNA

Roche and IBM announced today an agreement to develop a nanopore-based sequencer that will directly read and decode human DNA quickly and efficiently. Focused on advancing IBM's recently published "DNA Transistor" technology, the collaboration will take advantage of IBM's leadership in microelectronics, information technology and computational biology and Roche's expertise in medical diagnostics and genome sequencing.

1 Jul 2010

GSD signs agreement with Axis-Shield to distribute its proprietary assays in the U.S. Market

Gold Standard Diagnostics, Inc. a leading supplier of products and services to the medical diagnostic industry today announced the execution of an agreement with Axis-Shield to distribute their proprietary assays in the U.S. Market. Axis-Shield owns a number of patents in the areas of cardiovascular and neurodegenerative diseases, rheumatoid arthritis, diabetes and more recently, sepsis. GSD will initially focus on distribution of Homocysteine, but also gains access to distribute Axis-Shield's other key products such as Anti-CCP.

1 Jul 2010

Khon Kaen University deploys Aruba's adaptive Wi-Fi networks and AirWave Wireless Management System

Aruba Networks, Inc., a global leader in distributed enterprise network solutions, today announced that Thailand's Khon Kaen University Faculty of Medicine has deployed its adaptive Wi-Fi networks and AirWave Wireless Management System to support X-Ray image archiving, healthcare and drug dosage record access, and Internet access to 2,000 staff members and 1,200 students. The new system replaces legacy Cisco and 3COM autonomous FAT access points, and was deployed by Aruba authorized partner World Information Technology Company.

30 Jun 2010

USPTO grants Vermillion Alzheimer's disease biomarker patent

Vermillion, Inc., a molecular diagnostics company, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance of a patent entitled "Biomarkers for Alzheimer's disease" to the Company.

29 Jun 2010

Claros point-of-care system for PSA receives European CE Mark approval

Claros Diagnostics, a developer of novel point-of-care in vitro diagnostic systems, today announced the CE Mark approval for its rapid quantitative point-of-care diagnostic platform, which can now be used for prostate specific antigen (PSA) testing throughout the European Union. The approved system consists of a small portable analyzer and credit card-sized disposable.

29 Jun 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

Response Biomedical signs subscription agreement for C$8 million private placement

Response Biomedical Corporation announced today the signing of a subscription agreement providing for the sale of C$8 million of its common shares to funds affiliated with OrbiMed Advisors, LLC. The closing of the private placement is subject to receipt of all necessary regulatory approvals, including the approval of the Toronto Stock Exchange and the shareholders of the Company.

29 Jun 2010

Shrink Nanotechnologies, Lydall enter technology integration and development agreement

Shrink Nanotechnologies, Inc., an innovative nanotechnology company developing products and licensing opportunities in the solar energy production, medical diagnostics and sensors, and biotechnology research and development tools businesses, announced today that it has entered into a technology integration and development agreement with Lydall, Inc..

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

Aeterna Zentaris, Almac collaborate on study of AEZS-108 doxorubicin LHRH targeted conjugate compound

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced a collaborative study with Almac's Diagnostics division for the Company's doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, aimed at determining LHRH receptor expression through the development of a companion diagnostic tool.

28 Jun 2010

Helicos BioSciences to develop, market MDx tests that utilize HeliScope Single Molecule Sequencer

Helicos BioSciences Corporation announced today that it is in the early stages of validating molecular diagnostic (MDx) tests that utilize its HeliScope® Single Molecule Sequencer. The HeliScope Sequencer's ability to sequence single molecules of natural, unamplified DNA or RNA simplifies the diagnostic testing workflow obviating the need for the amplification steps utilized by most genetic analysis methods.

28 Jun 2010

Cardiac MRI helps avoid hospital admissions for chest pain patients

A new study done by researchers at Wake Forest University Baptist Medical Center indicates that chest pain may no longer have to mean a hospital stay - there is another option for diagnosing heart-related chest pain that costs less and, in some cases, allows the patient to return home the same day.

28 Jun 2010

Patient enrollment completed in pilot study of CyPath labeling solution for early detection of lung cancer

Cancer diagnostics company Biomoda, Inc. today announced it completed patient enrollment and sample collection in a pilot study to determine the clinical sensitivity and specificity of its CyPath labeling solution for the early detection of lung cancer. Top-line data and results will be released when available.

25 Jun 2010

PGXL announces new contractual agreement with GH

PGXL, a Louisville-based molecular diagnostics laboratory, announced a new contractual agreement with Generation Health, Inc. The agreement makes PGXL a preferred genetic testing lab for GH. The lab will provide molecular diagnostic tests for GH, which will help physicians make therapeutic decisions and facilitate what has come to be known as "personalized medicine."

25 Jun 2010

Researchers develop new assay test for bladder cancer

Researchers from the Danish Cancer Society and the Herlev University Hospital of Copenhagen have developed a novel assay to test for multiple tumor markers in bladder cancer.

25 Jun 2010

MDS Nordion, Guerbet, Cyceron collaborate to develop new PET radiotracers for cancer diagnostics

MDS Nordion, a leading provider of products and services to the global health science market, Guerbet, a pharmaceutical group specialized in medical imaging, and Cyceron, a biomedical imaging centre in France, announced today they have entered into an agreement to develop new Positron Emission Tomography (PET) radiotracers for cancer diagnostics.

24 Jun 2010

Diagnostics News and Research

BIDMC calls for new training program for personalized healthcare

FIOCRUZ receives Brazil's Anvisa regulatory approval to market Chembio's Dual Path Platform HIV 1/2 rapid test

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

BioImagene, KUMC partner to develop Companion Algorithms for digital pathology

Roche, IBM announce agreement to develop nanopore-based sequencer for decoding human DNA

GSD signs agreement with Axis-Shield to distribute its proprietary assays in the U.S. Market

Khon Kaen University deploys Aruba's adaptive Wi-Fi networks and AirWave Wireless Management System

USPTO grants Vermillion Alzheimer's disease biomarker patent

Claros point-of-care system for PSA receives European CE Mark approval

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

Response Biomedical signs subscription agreement for C$8 million private placement

Shrink Nanotechnologies, Lydall enter technology integration and development agreement

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

Aeterna Zentaris, Almac collaborate on study of AEZS-108 doxorubicin LHRH targeted conjugate compound

Helicos BioSciences to develop, market MDx tests that utilize HeliScope Single Molecule Sequencer

Cardiac MRI helps avoid hospital admissions for chest pain patients

Patient enrollment completed in pilot study of CyPath labeling solution for early detection of lung cancer

PGXL announces new contractual agreement with GH

Researchers develop new assay test for bladder cancer

MDS Nordion, Guerbet, Cyceron collaborate to develop new PET radiotracers for cancer diagnostics

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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