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VIDAS TOXO IgG Avidity assay to test for recent Toxoplasma gondii infection receives FDA clearance

On May 18, the U.S. Food and Drug Administration cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis, sometimes known as cat scratch disease, developed the infection within the past four months.

20 May 2011

Sensitive troponin assays improve clinical outcome and cardiac patient management

Research presented this week at the International Federation of Clinical Chemistry Congress and Laboratory Medicine showed that using a lower diagnostic threshold for troponin improves clinical outcomes and patient survival in patients with suspected acute coronary syndromes.

19 May 2011

New breast cancer biomarker may help identify women's response to tamoxifen

Cancer researchers at the Kimmel Cancer Center at Jefferson and an international team of collaborators have discovered a biomarker in breast cancer that may help identify which women will respond to anti-estrogen therapy.

19 May 2011

Abbott RealTime PCR assay for measuring HCV viral load receives FDA marketing approval

Abbott announced today that it has received approval from the U.S. Food and Drug Administration to market its RealTime PCR (polymerase chain reaction) test for measuring the viral load of hepatitis C (HCV), the leading cause of liver cancer in the United States.

19 May 2011

Excaliber subsidiary merges with VistaGen

Excaliber Enterprises, Ltd. announced today that its wholly-owned subsidiary has merged with VistaGen Therapeutics, Inc., a private biotechnology company focused on stem cell-based drug rescue and drug development. As a result of the Merger, VistaGen is a wholly-owned subsidiary of Excaliber.

17 May 2011

New A+PSA assay more accurately detects prostate cancer

A new test for prostate cancer that measures levels of prostate specific antigen (PSA) as well as six specific antibodies found in the blood of men with the disease was more sensitive and more specific than the conventional PSA test used today, according to a study by researchers at UCLA's Jonsson Comprehensive Cancer Center.

17 May 2011

PGT, Quintiles collaborate to bring genomic testing into mainstream drug development

Quintiles, the world's leading biopharmaceutical services company, and Population Genetics Technologies Ltd., creator of innovative solutions to reduce the costs and complexity of large-scale genomic testing and enable correlations with clinical outcomes, today announced a commercial collaboration to bring genomic testing into mainstream drug development in order to produce safer, more effective medicines.

17 May 2011

Fluidigm launches 192.24 Dynamic Array integrated fluidic circuit for genome studies

Fluidigm Corporation today introduced its 192.24 Dynamic Array™ IFC, designed to genotype 192 samples against 24 SNP assays in a single run, providing 4,608 data points in just one hour. The 192.24 integrated fluidic circuit (IFC) has immediate applicability in agricultural biotechnology and genome wide association studies.

16 May 2011

GenturaDx completes external HSV 1&2 alpha studies for IDbox System

Molecular diagnostics company GenturaDx announces the completion of external HSV 1&2 alpha studies for its IDbox instrument and cassette-based tests. Conducted at an external CLIA laboratory, the study analyzed more than 130 samples, including more than 70 clinical specimens.

16 May 2011

Researchers help explain why smart drugs are not effective in some cancer patients

Some of the most effective and expensive cancer drugs, dubbed "smart drugs" for their ability to stop tumors by targeting key drivers of cancer cell growth, are not effective in some patients. In two related studies, Yale School of Medicine researchers examined one such driver, the EGF receptor, and found that a decoy receptor might be limiting the amount of drug that gets to the intended target.

12 May 2011

FDA clears Meridian's new C. difficile immunoassay

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received clearance from the U.S. Food and Drug Administration for a new Clostridium difficile immunoassay named Premier C. difficile GDH.

11 May 2011

Fluidigm announces availability of genetic assays and primers for integrated fluidic circuit technology

Fluidigm Corporation today announced the availability of assays and primers optimized for the company's integrated fluidic circuit technology.

10 May 2011

Charisela develops breakthrough adiponectin assay

Charisela Technologies, Inc., a manufacturer of advanced assays for flow cytometers, announced today that it has developed an adiponectin assay with major advantages over existing technologies, including the elimination of dilutions. Adiponectin (Acrp30), an adipocytokine, is important in many therapeutic arenas, including type 2 diabetes, obesity, atherosclerosis, and rheumatoid arthritis.

9 May 2011

FDA clears Affymetrix's new gene profiling reagents for use in microarray instrument system

Affymetrix, Inc. today announced that the U.S. Food and Drug Administration has cleared the addition of new gene expression reagents as accessories to its GeneChip Microarray Instrument System for in vitro diagnostic use, making Affymetrix the first in the industry to provide a comprehensive microarray-based clinical toolkit for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives. Affymetrix Gene Profiling Reagents offer unparalleled convenience by simplifying assay workflow, decreasing hands-on time, and reducing quality control testing compared to research-use-only-produced products.

9 May 2011

Epigenomics presents Septin9 blood test study data in colorectal cancer at DDW 2011

Epigenomics AG, the cancer molecular diagnostics company, reports that Dr. Uri Ladabaum, Associate Professor in the Department of Gastroenterology and Hepatology at the School of Medicine of Stanford University, has presented the results of a health economic analysis of potential future colorectal cancer screening with Septin9 blood tests at the ongoing Digestive Disease Week 2011.

9 May 2011

Inovio reports VGX-3100 Phase I study data in cervical dysplasia and cancer

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, has reported data demonstrating long-term durability of immune responses induced by VGX-3100, its investigational DNA vaccine for treating cervical dysplasia and cancer caused by human papillomavirus.

9 May 2011

Epigenomics, Life Technologies enter supply agreement for second-generation colorectal cancer blood test

Epigenomics AG, the cancer molecular diagnosis company, today announced the signing of a supply agreement with Life Technologies Corporation, a global provider of innovative life science solutions.

7 May 2011

Roche seeks FDA clearance for fully automated Chlamydia and gonorrhoeae test

Roche announced today that it has filed for FDA clearance of its Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) tests.

7 May 2011

BD MAX Open System for molecular testing launched in Europe

BD Diagnostics, a segment of BD, today announced the European launch of the BD MAX™ Open System for molecular testing, which will enable laboratories to run both laboratory and BD- developed assays and offer enhanced testing services that elevate the standards of care at their institutions.

From BD (Becton, Dickinson and Company) 6 May 2011

Two breast cancer genomic tests produce broadly similar results for high and low-risk patients

Two multi-gene tests designed to predict the risk of disease progression and response to chemotherapy in breast cancer produce broadly similar results for high- and low-risk patients, but do not always agree in their predictions for those at intermediate risk, a new analysis shows.

5 May 2011

Assay News and Research

VIDAS TOXO IgG Avidity assay to test for recent Toxoplasma gondii infection receives FDA clearance

Sensitive troponin assays improve clinical outcome and cardiac patient management

New breast cancer biomarker may help identify women's response to tamoxifen

Abbott RealTime PCR assay for measuring HCV viral load receives FDA marketing approval

Excaliber subsidiary merges with VistaGen

New A+PSA assay more accurately detects prostate cancer

PGT, Quintiles collaborate to bring genomic testing into mainstream drug development

Fluidigm launches 192.24 Dynamic Array integrated fluidic circuit for genome studies

GenturaDx completes external HSV 1&2 alpha studies for IDbox System

Researchers help explain why smart drugs are not effective in some cancer patients

FDA clears Meridian's new C. difficile immunoassay

Fluidigm announces availability of genetic assays and primers for integrated fluidic circuit technology

Charisela develops breakthrough adiponectin assay

FDA clears Affymetrix's new gene profiling reagents for use in microarray instrument system

Epigenomics presents Septin9 blood test study data in colorectal cancer at DDW 2011

Inovio reports VGX-3100 Phase I study data in cervical dysplasia and cancer

Epigenomics, Life Technologies enter supply agreement for second-generation colorectal cancer blood test

Roche seeks FDA clearance for fully automated Chlamydia and gonorrhoeae test

BD MAX Open System for molecular testing launched in Europe

Two breast cancer genomic tests produce broadly similar results for high and low-risk patients

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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