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AACC Joins AMA, Others Urging FDA to Withdraw Proposed Framework for Laboratory Developed Tests

The FDA issued its long-awaited proposal on Oct. 3 for overseeing laboratory developed tests -- medical tests that are created and used within a single lab, and often developed to fulfill unmet clinical needs. AACC is concerned that this guidance could hinder the ability of labs to provide physicians with the vital information they need to treat patients, and has joined the American Medical Association (AMA), American Hospital Association (AHA), and 48 other major healthcare organizations in ...

Posted on: November 20, 2014
BloodCenter of Wisconsin Launches Next Generation Sequencing HemeOnc Panel

BloodCenter of Wisconsin's Diagnostic Laboratories have announced the availability of a comprehensive cancer mutation HemeOnc Panel using next generation sequencing (NGS) technology. The NGS panel developed by BloodCenter of Wisconsin is designed to detect variants in 30 genes that are either prognostic or diagnostic for 10 different myeloid hematologic malignancies.Genetic profiling of hematologic malignancies through NGS is transformative technology for cancer diagnostics and patient care.BloodCenter's ...

Posted on: November 20, 2014
New Test Will Combat Major Cause of Preventable Blindness In Africa

A new test will accelerate global progress toward eliminating onchocerciasis, a leading cause of preventable blindness in Africa. PATH, an international nonprofit health organization, has announced the availability of the SD BIOLINE Onchocerciasis IgG4 rapid test, manufactured and distributed by Standard Diagnostics. Designed for use in disease surveillance, the antibody-based test is faster, easier-to-use, and more acceptable to impacted communities than the current option. It is the first in a suite of ...

Posted on: November 19, 2014
PDI Prevantics Device Swab Is Only 3.15% Chlorhexidine Gluconate/70% Alcohol Solution with FDA Market Authorization

Clinical investigators recently released results from the first and only randomized, cross-over, prospective, comparative effectiveness clinical study evaluating the benefits of a 3.15% Chlorhexidine Gluconate (CHG) and 70% Isopropyl Alcohol over 70% Isopropyl Alcohol alone in disinfecting needleless connectors. The study was funded by the CDC Epicenters Program and executed by Rush University in Chicago, Ill. The results were presented at the 2014 IDWeek Conference in Philadelphia on Oct.11.The ...

Posted on: November 18, 2014
Quest Diagnostics Introduces BRCAvantage Plus, Providing New Choices in Genetic Breast Cancer Risk Testing

Quest Diagnostics, the world's leading provider of diagnostic information services, has announced BRCAvantage Plus, the company's first suite of lab-developed test services for assessing genetic breast cancer risk based on clinically validated non-BRCA as well as BRCA genes. The new service is now available in all 50 states.BRCAvantage Plus is the first major line extension to BRCAvantage, a suite of lab-developed tests for assessing BRCA1 and BRCA2 gene mutations launched ...

Posted on: November 17, 2014
University Hospitals Case Medical Center Expands Use of Data Analytics to Include Microbiology and Billing/Accounts Receivables

Viewics Inc. today has announced that University Hospitals Case Medical Center in Cleveland, Ohio, is expanding its use of Viewics Health Insighter (VHI) by adding the solution on its microbiology department's SCC Soft Computer Microbiology information system, SoftMic, as well as their billing and accounts receivable system SoftA/R. UH Case Medical Center went live with VHI in November 2013 within their clinical and anatomic pathology laboratories. Due to the return on investment they have received within ...

Posted on: November 17, 2014
Scientists Generate First Human Stomach Tissue in Lab with Stem Cells

Scientists used pluripotent stem cells to generate functional, three-dimensional human stomach tissue in a laboratory - creating an unprecedented tool for researching the development and diseases of an organ central to several public health crises, ranging from cancer to diabetes.Scientists at Cincinnati Children's Hospital Medical Center reported in Nature they used human pluripotent stem cells - which can become any cell type in the body - to grow a miniature version of the stomach. In collaboration ...

Posted on: November 16, 2014
Medicare to Cover Combinatorial Genetic Testing to Guide Individualized Selection Of Depression Meds

The promise of genetic testing to guide more effective treatment for millions of older and disabled Americans suffering from depression has shifted from a futuristic vision to a practical reality.Medicare has issued a Local Coverage Determination (LCD) that will provide coverage for GeneSight Psychotropic, the first combinatorial pharmacogenomic test to help guide medication decisions for depression.  Prior to GeneSight, no psychiatric pharmacogenomic test has achieved a favorable coverage decision ...

Posted on: November 14, 2014
Beckman Coulter's Hemoglobin A1c Test Available on All Clinical UniCel DxC and AU Chemistry Systems

Beckman Coulter Diagnostics has launched its next generation Hemoglobin A1c (HbA1c) assay with improved performance across all of its chemistry systems. The assay has been standardized for use on all platforms of the company's AU clinical chemistry systems for offline sample preparation use, in addition to online sample preparation use on the company's UniCel DxC systems. FDA 510(k) clearance has been received for this assay on both the AU and DxC series of chemistry analyzers. The next generation ...

Posted on: November 13, 2014
ASCP and ASH Partner on Grant to Enhance and Expand MDS Curriculum

The American Society for Clinical Pathology (ASCP) and the American Society of Hematology (ASH) have announced that the two organizations are partnering on an independent educational grant from Summit, N.J.-based Celgene Corporation to update, enhance and expand ASCP's existing Myelodysplastic Syndromes (MDS) curriculum. This represents the second independent educational grant award by Celgene to ASCP for this program. The curriculum titled, "The Diagnosis, Classification, and Clinical Care of MDS ...

Posted on: November 12, 2014
Cartagenia Launches Advanced Genetic Variant Assessment Platform for NIH Undiagnosed Disease Program

Cartagenia, a leader in providing genetic labs and clinicians with software-based workflow support for variant assessment, lab reporting, and integration of diagnostic knowledge-bases, announced today the successful launch of a software platform for genetic variant assessment and reporting within the National Institutes of Health (NIH) Undiagnosed Disease Program (UDP). Over the past year, Cartagenia has been engaged by NIH  to build a tailored version of the Cartagenia Bench Lab platform - a ...

Posted on: November 11, 2014
Beckman Coulter Genomics Integrates Clarity LIMS

Beckman Coulter Genomics, providers of expert genomics solutions to research and healthcare institutions worldwide, has integrated a Genologics Clarity Laboratory Information Management System (LIMS) into their Illumina HiSeq-based workflows to offer Next Generation Sequencing (NGS) with the highest level of data management and methods control.RNA sequencing, target capture, whole-genome sequencing and pre-made library samples are tracked by the LIMS from acquisition through QC, library prep and Illumina ...

Posted on: November 10, 2014
Quest Diagnostics Names Mayo Clinic Executive Franklin R. Cockerill, MD, Vice President and Chief Laboratory Officer

Quest Diagnostics, the world's leading provider of diagnostic information services, recently named Franklin R. Cockerill, III, MD, vice president and chief laboratory officer.Cockerill will oversee quality, regulatory, technology, standardization and medical operations across Quest's network of laboratories and will play a major role in advancing Quest's medical affairs, academic and government strategies and collaborations. Cockerill succeeded Stephen C. Suffin, MD, who previously announced plans to ...

Posted on: November 09, 2014
Sylvester, Holmberg Win ASBP's 2014 Lifetime Achievement Award

The Armed Services Blood Program awards retired Air Force Lt. Col. Ruth Sylvester and retired Navy Cmdr. Jerry Holmberg with this year's Lifetime Achievement Award.  Both Sylvester and Holmberg have had distinguished military careers, leaving a long-lasting impact on the military banking community. Established in 2009, the Lifetime Achievement Award has since recognized those who exemplify tireless dedication to the military blood program. Each year, the ASBP awards individuals whose ...

Posted on: November 07, 2014
Leica Biosystems to Acquire Devicor Medical Products

Leica Biosystems, a global leader in anatomic pathology laboratory solutions and instruments, announced that it has entered into a definitive agreement to acquire Devicor Medical Products, Inc.Devicor is a global market leader in breast biopsy instruments and consumables, with annual revenues of approximately $170 million. Devicor, headquartered in Cincinnati, Ohio, has more than 550 employees and sells products in more than 50 countries around the world. "Leica Biosystems' products and solutions address ...

Posted on: November 06, 2014
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