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Cola Seeks Waived Labs to Participate In Pilot Programs

COLA, a leading U.S. laboratory accreditor, is launching a Waived Testing Pilot Program, designed to obtain laboratory feedback on a series of products for waived labs. Participating laboratories will receive complimentary lab resources, ranging from an on-site survey to enrollment in year-long Proficiency Testing, depending on the pilot program.The accreditor plans to conduct four pilot programs starting this fall. These include: Training Competency - Pilot labs will be provided with a ...

Posted on: October 01, 2014
Clinical Results Presented for Trovagene's Urine-Based High-Risk HPV Assay.

Trovagene Inc.,a developer of cell-free molecular diagnostics, announced that results from two independent clinical studies, were presented at the 29th International Papillomavirus (IPV) Conference, demonstrated that the company's urine-based assay for the detection of high-risk HPV had high sensitivity (greater than 90%) for identifying women with high grade cervical intraepithelial neoplasia (CIN2/3). Assay performance was comparable to traditional HPV testing with commercially available tests in ...

Posted on: September 30, 2014
Novel Biomarker May Detect Early Rheumatoid Arthritis Better than Conventional Methods Alone

A novel biomarker for rheumatoid arthritis (RA) has significant potential to help physicians better identify early-stage disease, when treatment can often arrest further disease progression and disability, according to a new study in The Journal of Rheumatology.Researchers from Quest Diagnostics and other institutions found that elevated blood-serum levels of the 14-3-3eta protein outperformed conventional antibody-serum testing, including rheumatoid factor (RF) and anti-citrullinated peptide antibodies ...

Posted on: September 29, 2014
Sunquest Information Systems and Cellnetix Forge Strategic Partnership to Transform Diagnostic Workflow in Labs

Sunquest Information Systems, the market leading lab information service provider for anatomic pathology, and CellNetix Pathology & Laboratories, recognized for pathology excellence and creating a new model for the delivery of pathology professional and technical services, have announced a strategic partnership to transform pathology workflow.This partnership aims to redefine the Pathology workflow, addressing key industry challenges around case reporting, integration of molecular and genetics, and ...

Posted on: September 28, 2014
WHO Recommends Use of p16 IHC to Help Diagnose High-Grade Cervical Disease

Ventana Medical Systems has announced that the World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease. In doing so, the WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012. Traditionally, the ...

Posted on: September 26, 2014
German Biotech Company sphingotec Expands into the U.S.

sphingotec GmbH (www.sphingotec.de/en/)  has established its U.S. headquarters in Cambridge, Mass. The Germany-based biotechnology company develops tests to detect individual risk factors for cancer, cardiovascular conditions and kidney disease. Its expansion into the U.S. will enable sphingotec to more rapidly meet growing market demand.Commercial activities in the U.S. will be led by Karla M. Gonye, who will serve as president of the U.S. subsidiary. Gonye's experience includes more than 20 ...

Posted on: September 25, 2014
Genomic Health to Present Positive Results from Latest Prostate Cancer Clinical Validation Study at the European Society for Medical Oncology Congress

Genomic Health Inc. will present results from nine studies of Oncotype DX in prostate, breast and renal cancers at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Sept. 26 - 30. Included in the program is the first presentation of strongly positive results from an additional large independent clinical validation study of the Oncotype DX prostate cancer test, conducted in collaboration with the Center for Prostate Disease Research, Rockville, Md. This new study demonstrates ...

Posted on: September 24, 2014
Astute Medical to Release First Test for Risk Assessment of Kidney Injury

A novel test used to assess risk for acute kidney injury (AKI) could help physicians significantly improve management of intensive care unit (ICU) patients at risk for AKI, who annually account for 5 million admissions. Inadequacies in assessment and management of AKI have been cited as contributing to an increased number of deaths and excess healthcare costs.Astute Medical Inc. has received 510(k) clearance through the FDA's de novo classification process for its first biomarker-based immunoassay known ...

Posted on: September 23, 2014
CRI IQCP Workshops Help Labs Prep for CMS IQCP Interpretive Quality Control Guidelines

CRI's IQCP Workshops, presented by leading experts in the field of IQCP, will be held Oct. 15, at the CRI Symposium for Clinical Laboratories, at Buena Vista Palace Hotel & Spa, 1900 E. Buena Vista Drive, Orlando, Fla. The full-day interactive workshops include informative presentations by several experts in the field of risk assessment.CRI IQCP Workshops also include hands-on breakout sessions to create an IQCP for your laboratory in a live setting and to review your plan with the experts. Each ...

Posted on: September 22, 2014
American Society of Hematology Endorses New NHLBI Report on Sickle Cell Disease

The American Society of Hematology (ASH), the world's largest professional organization dedicated to the causes and treatments of blood disorders, has endorsed a new evidence-based expert panel report on the management of sickle cell disease published by the National Heart, Lung, and Blood Institute (NHLBI) aimed at improving the care of patients with sickle cell disease (SCD).SCD is an inherited, lifelong disorder affecting nearly 100,000 Americans. Individuals with the disease produce abnormal ...

Posted on: September 21, 2014
COLA Receives ISO Recertification

COLA, an internationally respected clinical laboratory accreditation firm, has been recertified as meeting high "Quality Management System" standards established by the International Organization for Standardization (ISO), an international-standard-setting body composed of representatives from various standards organizations.COLA's recertification, which comes from ISO registrar British Standards Institute (BSI), covers COLA's delivery and administration of its CLIA-equivalent accreditation program ...

Posted on: September 20, 2014
Myriad myPath Melanoma Test Reduced Indeterminate Cases by 76% and Changed Treatment in 35% of Cases

Myriad Genetics, Inc. recently presented results from a pivotal clinical utility study of the Myriad myPath Melanoma test at the 2014 College of American Pathologists (CAP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a novel diagnostic test that differentiates malignant melanoma from benign skin lesions with greater than 90% accuracy and helps physicians deliver a more objective andconfident diagnosis for patients.This study evaluated the impact of the myPath Melanoma diagnostic test on ...

Posted on: September 19, 2014
Orlando Symposium to Feature Wide-Ranging Topics for Laboratorians

The educational subsidiary of COLA, COLA Resources Inc. (CRI), will sponsor a Symposium for Clinical Laboratories Oct. 15-18 at the Buena Vista Palace Hotel and Spa, Orlando, FL. The conference is expected to draw professionals from every area of laboratory medicine -- including physicians operating an office laboratory, diagnostic laboratory staff, physician assistants, nurses and other medical personnel -- for a series of educational and networking opportunities.The ...

Posted on: September 19, 2014
Aquaro Biosystems' Pacesetter Section Mounting System Enables Hands-Free Operation

Aquaro Biosystems introduced its PaceSetter section mounting system, a product developed to streamline the histology workflow, at the National Society for Histotechnology Annual Convention in Austin, Texas. The PaceSetter is the first benchtop instrument to automate the transfer of paraffin-embedded tissue sections directly from microtomes to glass slides.The PaceSetter section mounting system, which attaches directly and easily to microtomes, uses a water channel to gently transfer sections to glass ...

Posted on: September 17, 2014
Human Brain Deficits of PKCe: Targeted for Alzheimer's Disease Diagnostic and Therapeutic Trials

Researchers at the Blanchette Rockefeller Neurosciences Institute (BRNI) recently announced findings from a new study entitled, "PKCe Deficits in Alzheimer's Disease Brains and Skin Fibroblasts."  These new findings offer significant promise for a new therapeutic and diagnostic approach to Alzheimer's disease (AD) that has remained so refractory to effective and early drug treatment. This approach is now the major focus of ongoing clinical trials being conducted by at BRNI/Neurotrope Inc. ...

Posted on: September 17, 2014
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