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QIAGEN Announces First-Ever Regulatory Registration of Lung Cancer CDx Based on Liquid Biopsies

QIAGEN has announced the CE-IVD marking of its novel liquid biopsy-based companion diagnostic that analyzes circulating nucleic acids obtained from blood samples to assess an important genomic mutation in patients with non-small cell lung cancer (NSCLC), the most common form of this cancer. The registration, which applies to more than 30 European countries, makes the new therascreen EGFR RGQ Plasma PCR kit the first-ever regulated companion diagnostic assay that has demonstrated clinical utility for ...

Posted on: January 30, 2015
bioMerieux and Astute Medical to Co-Develop NephroCheck Assay to Assess Risk of Acute Kidney Injury

bioMérieux, a world leader in the field of in vitro diagnostics, and Astute Medical, a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers, have announced an agreement regarding the development of a test for the early risk assessment of acute kidney injury (AKI). This innovative test, known as the NephroCheck Test, detects the presence of two biomarkers: TIMP-2 (Tissue Inhibitor Metalloproteinases-2) ...

Posted on: January 29, 2015
New Molecular Diagnostic Methods Could Reduce Risk of Miscarriage in Prenatal Testing for Genetic Diseases

Early diagnosis and treatment are crucial to improving patient prognosis for 22q11 deletion syndrome and Wilson's disease, two potentially life-threatening genetic conditions. Breaking research in the Molecular Diagnostics issue of Clinical Chemistry, the journal of AACC, shows for the first time that a more precise technology for quantifying DNA could enable all newborns to be tested for 22q11 deletion syndrome; and that a new method known as cSMART can diagnose a fetus with Wilson's disease without the ...

Posted on: January 28, 2015
Pivotal Data for T2Candida and T2Dx Published in Clinical Infectious Diseases

T2 Biosystems, a company developing innovative diagnostic products to improve patient health, has announced that results from its pivotal trial evaluating its lead products, the T2Candida Panel and the T2Dx Instrument were published online in the journal Clinical Infectious Diseases (CID). The results will also appear in a forthcoming print issue of the journal.T2Candida and T2Dx were cleared for use by the FDA on Sept. 22, 2014, for the direct detection ...

Posted on: January 27, 2015
Loyola Offers Patients Free HIV Testing

Loyola University Health System has now expanded free HIV testing to patients at the Loyola Center for Health at River Forest. "HIV affects people of all ages, all races and all economic backgrounds; it is not just an urban phenomenon but exists in the suburbs," says Jerry Goldstein, research coordinator, Loyola University Health System. "The more people tested, the earlier the detection and the faster treatment is offered to save lives and prevent the spread of infection."Funded by a CDC research grant ...

Posted on: January 26, 2015
Albert Einstein College of Medicine Announces New Chair of Department of Microbiology & Immunology

Albert Einstein College of Medicine of Yeshiva University has named Steven A. Porcelli, M.D., the new chair of the department of microbiology & immunology. A noted immunologist, Dr. Porcelli is currently the Murray and Evelyne Weinstock Chair in Microbiology & Immunology and professor of medicine at Einstein.Dr. Porcelli graduated summa cum laude from Columbia University, received his M.D. from Yale University and completed a medical residency at Temple University ...

Posted on: January 25, 2015
Researchers Find That Tumor DNA and Cells in the Blood Can Be Used to Diagnose Prostate Cancer and Drug Resistance in Breast Cancer

The "Molecular Diagnostics" issue of Clinical Chemistry, the journal of AACC, features new research on a genetic test for prostate cancer that could replace the unreliable prostate specific antigen (PSA) test, as well as a more accurate test for breast cancer drug resistance. Both tests could help patients receive more targeted treatment for prostate and breast cancer, which in the U.S. are the second leading causes of cancer death in men and women, respectively.Though the prostate specific antigen (PSA) ...

Posted on: January 23, 2015
QIAGEN Launches QuantiFERON-TB Gold Plus for Detecting Tuberculosis Infections

QIAGEN N.V. has announced the CE product launch of QuantiFERON-TB Gold Plus (QFT-Plus), the fourth generation of the most accurate test for detecting tuberculosis (TB) infections.QFT-Plus builds on the legacy of QuantiFERON-TB Gold, which was the third-generation version of this important technology that has established itself as a cost-effective tool for TB infection testing with more than 20 million tests distributed worldwide since its initial launch. QFT-Plus, which was recently CE-IVD marked, is now ...

Posted on: January 22, 2015
New Recommendation for Cervical Cancer Screening, Using HPV Test Alone

About 80 million U.S. women ages 25 to 65 should be screened periodically by their health care providers for cervical cancer. At present, the standard way to do that is a Pap smear alone, or co-testing using both a Pap smear and a human papillomavirus (HPV) test.Today, the clinicians who care for those women are getting new interim guidance about the health advantages of instead using the HPV test alone as the primary screen to find cervical cancer or its precursors. Under the new guidance, the Pap smear, ...

Posted on: January 21, 2015
Carolina Liquid Chemistries Expands Branded Line of Chemistry Analyzers for Clinical Laboratories, CLC720i Chemistry Analyzer Receives FDA Clearance

Carolina Liquid Chemistries Corp. (CLC), Winston-Salem, NC, recently expanded their branded line of chemistry analyzers.  The company, known for providing clinical laboratories with instruments and reagents to run over 80 different tests to diagnose and treat patients, now offers the CLC720i. The CLC720i meets the needs of a mid-volume clinical laboratory, while offering innovative technologies not seen on other analyzers. The CLC720i produces up to 400 photometric tests and 240 ISE tests per hour ...

Posted on: January 20, 2015
Strategic Alliance between bioMérieux and COPAN to Automate Clinical Microbiology Labs and Enhance Operational Efficiency

bioMérieux, a world leader in the field of in vitro diagnostics, and COPAN, a leading manufacturer of innovative pre-analytic solutions, are pleased to announce that they have signed a strategic partnership in clinical microbiology laboratory automation. Under the terms of the agreement, COPAN has granted distribution rights for itsautomated platforms (including the WASP Walk-Away Specimen Processor and the WASPLab solutions which automate microbiology laboratory tasks and provide ...

Posted on: January 19, 2015
Korean Scientists Publish Results on Colorectal Cancer Screening Using M2-PK Test

Scientists from the College of Medicine at the Catholic University of Korea have published newest data on the M2-PK test from a multi-center study of colorectal cancer screening in the journal Gut and Liver. The results from cancer expert Prof. Yong Kim and his colleagues confirm the exceptionally high capability of the M2-PK test, particularly in comparison to the immunological fecal occult blood test (iFOBT), to detectadenomas and colorectal cancer.In their study Kim and colleagues investigated the ...

Posted on: January 18, 2015
Revisions to Molecular Testing Guideline Continue to Give Hope to Lung Cancer Patients

The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) are teaming to revise the evidence-based guideline, "Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors."The updated guideline will include new recommendations for ALK testing by IHC, ALK-EGFR resistance, and a number of emerging target molecular targets which will include, but is not ...

Posted on: January 18, 2015
New Resource Offers Curriculum to Move Pathologists to Forefront of Genomic Medicine

A new educational resource-The Genomic Pathology Workshop Instructor's Handbook and Toolkit-developed through a five-year, $1.3 million grant from the National Institutes of Health (NIH), is now available for pathology trainees worldwide.Developed by the Training Residents in Genomics (TRIG) Working Group with educational design support from the American Society for Clinical Pathology (ASCP), the handbook and accompanying online toolkit can be downloaded for free at www.pathologylearning.org/trig. The ...

Posted on: January 16, 2015
Beckman Coulter Genomics Receives Accreditation from CAP

Beckman Coulter Genomics, a leading provider of DNA Sequencing Services has announced accreditation from the College of American Pathologists (CAP). Furthering a long-standing commitment to delivering state-of-the-art sequencing services and high levels of customer satisfaction, the facility in Danvers completed a comprehensive on-site inspection as part of the CAP's Accreditation Programs.  The CAP Laboratory Accreditation Program involves a process of inspections of clinical lab records ...

Posted on: January 15, 2015
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