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Roche to provide the RealTime ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs under EUA

The Roche assay for the 2009 H1N1 influenza virus detects RNA from the 2009 H1N1 Influenza A virus and provides a rapid means of identification of patients infected with this virus. In order to ensure continued specificity and sensitivity of the Roche's Influenza A/H1N1 assay, Roche performs sequence comparisons with all available 2009 H1N1 Influenza Virus sequences on a regular basis.

3 Dec 2009

Novel multi-analyte approach to develop urine-biomarker based diagnostic assay to be presented

Predictive Biosciences today announced that Company scientists will be presenting a novel multi-analyte approach to the development of a non-invasive, urine-biomarker based diagnostic assay during the 10th Annual Meeting of the Society of Urologic Oncology (SUO).

3 Dec 2009

Over twenty new drug metabolism assays launched by Absorption Systems

Absorption Systems, a leader in drug safety and ADMET (absorption, distribution, metabolism, excretion and toxicity) testing, today announced the introduction of a more complete series of drug metabolism assays designed to support the pharmaceutical R&D process, from early-stage discovery through late-stage clinical development.

2 Dec 2009

FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

Roche announced today that the United States Food & Drug Administration (FDA) approved an additional intended use for its licensed nucleic acid test, to screen source plasma in pools comprised of up to 96 individual donations. The test, called the cobas® TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative, in-vitro test for the simultaneous, direct detection of the human immunodeficiency virus (HIV-1 Group M RNA, HIV-1 Group O RNA , HIV-2 RNA), hepatitis C virus RNA and hepatitis B virus DNA in human plasma.

From Roche Sequencing and Life Science 2 Dec 2009

Avioq receives premarket approval from FDA for Avioq HIV-1 Microelisa System

Avioq, Inc. announced it has received premarket approval from the U.S. Food and Drug Administration (FDA) for the Avioq HIV-1 Microelisa System.

1 Dec 2009

FDA provides marketing clearance for Prodesse's ProParaflu+ assay

Gen-Probe Incorporated announced today that the US Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProParaflu+(TM) assay, a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections.

25 Nov 2009

New technology developed to rapidly identify compounds for the treatment of heart failure

Research conducted by University of Minnesota scientists, in collaboration with Celladon Corporation, has led to the invention of technology to more rapidly identify compounds for the treatment of heart failure.

24 Nov 2009

STD infections continue to rise among young people

Sexually spread diseases continue to rise, with reported chlamydia cases setting yet another record in 2008, officials at the Centers for Disease Control recently reported. The CDC estimates that approximately 19 million new STD infections occur each year. Approximately half of them occur in young people between 15 to 24 years of age.

23 Nov 2009

WPI researchers develop new model system to study fungal infections

A team of researchers at the Worcester Polytechnic Institute (WPI) Life Sciences and Bioengineering Center at Gateway Park has developed a new model system to study fungal infections. The system can be a powerful tool for screening potential drug targets for conditions like thrush, athlete's foot and vaginal yeast infections, which affect millions of people each year but are difficult to treat with existing medications. Using the new model, the researchers also identified a gene that may be a promising target for a new anti-fungal drug.

20 Nov 2009

NanoString Technologies to investigate molecular networks with the Broad Institute of MIT and Harvard

NanoString Technologies, Inc., a privately held life sciences company marketing a molecular barcoding detection system, today announced that it is collaborating with the Broad Institute of MIT and Harvard to investigate molecular networks involved in immune response and other important biological processes.

From NanoString Technologies 19 Nov 2009

Ionian Technologies receives supplemental funding from the Gates Foundation

Ionian Technologies, Inc., will continue its efforts to develop a rapid point-of-care diagnostics platform for use in the developing world with supplemental funding from the Bill & Melinda Gates Foundation. This grant from the Foundation will extend the total commitment to this program, which was initiated in November 2008, to $3 million over two years.

18 Nov 2009

Chembio Diagnostics to present possibilities of OTC home-use HIV test kits at the FDA meeting

Chembio Diagnostics, Inc., a company that develops, manufactures, licenses, and markets proprietary rapid diagnostic tests, announced today that it will present at a meeting of the Blood Products Advisory Committee ("BPAC") of the U.S. Food and Drug Administration ("FDA") in Bethesda, Maryland, on the afternoon of November 17, 2009.

18 Nov 2009

Verax Platelet PGD test receives FDA clearance

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today that the U.S. Food and Drug Administration has cleared the Verax Platelet PGD® test as a quality control test to detect bacterial contamination in whole blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive global distributor of the test, which was developed by Verax Biomedical of Worcester, Mass.

18 Nov 2009

Asterand to acquire BioSeek

Asterand plc (LSE: ATD), a leading provider of human tissue and human tissue-based services to pharmaceutical and biotechnology companies engaged in drug discovery research, today announces it has signed an agreement to acquire BioSeek Inc.

18 Nov 2009

Asuragen enters into an exclusive agreement with Life Technologies

Asuragen, Inc. announced today that it has entered into an exclusive agreement with Life Technologies Corporation to develop and distribute worldwide an in-vitro diagnostic test intended to aid clinicians in the monitoring and treatment of individuals afflicted with chronic myeloid leukemia (CML).

18 Nov 2009

Quest Diagnostics' Simplexa Influenza A H1N1 (2009) test receives CE mark

Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, today announced that the Simplexa Influenza A H1N1 (2009) test developed by its Focus Diagnostics business has been CE marked and is now available as a test kit for distribution to approximately 35 countries in Europe.

From Quest Diagnostics 18 Nov 2009

Study to test anti-tumor effects of AEOL 10150 initiated

Aeolus Pharmaceuticals, Inc. announced today the initiation of a study to test the anti-tumor effects of AEOL 10150 when combined with radiation and chemotherapy in nude mice bearing human non-small cell lung cancer (NSCLC) xenografts.

18 Nov 2009

Abbott and BG Medicine announce a development and commercialization agreement for galectin-3 biomarker

Abbott and BG Medicine, Inc. today announced a development and commercialization agreement for galectin-3, a novel biomarker that may play a role in detecting the development and progression of heart failure. The assay will be developed for Abbott's ARCHITECT immunochemistry instrument platform, specifically the company's i1000SR and i2000SR instruments. The agreement grants Abbott a license to BG Medicine's intellectual property related to galectin-3.

17 Nov 2009

CD4 Initiative selects Zyomyx's CD4 POC technology as best for measuring CD4 T-cell count in HIV/AIDS patients

Zyomyx, Inc., a leader in chip-based bioanalysis technologies, today announced that its readerless CD4 point-of-care (POC) technology was selected by Imperial College London's CD4 Initiative as the best-performing POC test method for measuring CD4 T-cell count in HIV/AIDS patients. Zyomyx's CD4 assay is now the only remaining POC product being supported by the CD4 Initiative.

17 Nov 2009

Roche receives EUA from FDA for its RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 virus

Roche`s RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The Roche kit detects RNA from the 2009 H1N1 influenza A virus and allows rapid and accurate identification of patients infected with this virus.

17 Nov 2009

Assay News and Research

Roche to provide the RealTime ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs under EUA

Novel multi-analyte approach to develop urine-biomarker based diagnostic assay to be presented

Over twenty new drug metabolism assays launched by Absorption Systems

FDA approves additional intended use of Roche's cobas TaqScreen MPX Test

Avioq receives premarket approval from FDA for Avioq HIV-1 Microelisa System

FDA provides marketing clearance for Prodesse's ProParaflu+ assay

New technology developed to rapidly identify compounds for the treatment of heart failure

STD infections continue to rise among young people

WPI researchers develop new model system to study fungal infections

NanoString Technologies to investigate molecular networks with the Broad Institute of MIT and Harvard

Ionian Technologies receives supplemental funding from the Gates Foundation

Chembio Diagnostics to present possibilities of OTC home-use HIV test kits at the FDA meeting

Verax Platelet PGD test receives FDA clearance

Asterand to acquire BioSeek

Asuragen enters into an exclusive agreement with Life Technologies

Quest Diagnostics' Simplexa Influenza A H1N1 (2009) test receives CE mark

Study to test anti-tumor effects of AEOL 10150 initiated

Abbott and BG Medicine announce a development and commercialization agreement for galectin-3 biomarker

CD4 Initiative selects Zyomyx's CD4 POC technology as best for measuring CD4 T-cell count in HIV/AIDS patients

Roche receives EUA from FDA for its RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 virus

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