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PCL Alverno, in Partnership with Beckman Coulter Diagnostics, Unveils New Fully Automated Laboratory

PCL Alverno, a full service, community-based medical laboratory, in partnership with Beckman Coulter Diagnostics, unveiled its new, fully automated laboratory solutions at the Alverno Central Laboratory facility in Hammond, Ind. PCL Alverno Clinical Laboratories awarded Beckman Coulter Diagnostics the new installation agreement in February 2014. Processing more than 23 million tests per year, and dedicated to improving the quality of patient care, PCL Alverno was recently named a leader in innovation in ...

Posted on: March 27, 2015
AMP Submits Written Comments to FDA on NGS Regulation, Need for Consistent Tests

The Association for Molecular Pathology (AMP), the global, non-profit organization serving molecular diagnostic professionals, submitted written comments on March 20 to the U.S. Food and Drug Administration (FDA) in response to the agency's request for feedback in association with its February 20, 2015 public workshop entitled, "Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests." In its comments, AMP urged FDA to focus its attention on helping to ensure the performance ...

Posted on: March 26, 2015
Take a Look Inside Einstein's Brain

Leica Biosystems, a global leader in automation and workflow solutions for anatomic pathology, is providing participants of the USCAP meeting in Boston, Mass., through Friday, with a rare opportunity to look inside Albert Einstein's brain.Leica Biosystems invites attendees to come to the Best Brains in Pathology exhibit at booth #901 to explore over 500 slides of Einstein's brain and examine the Nobel Prize-winning physicist's neuroanatomy. The original slides were prepared by Dr. Thomas Harvey, who ...

Posted on: March 25, 2015
Denver Health Medical Center and Accelerate Diagnostics Awarded $5 Million Grant To Study Antibiotic Resistant 'Super Bug'

The National Institutes of Health awarded a five year, $5 million grant to Denver Health Medical Center and Accelerate Diagnostics to develop a fast and reliable test to detect common bacteria directly from blood, with corresponding antibiotic susceptibility, in less than three hours. This study will focus on the detection of an antibiotic resistant "Super Bug" known as carbepenem-resistant Enterobacteriaceae (CRE).The challenge physicians currently face in diagnosing infections caused by bacteria is that ...

Posted on: March 24, 2015
First Liquid Biopsy RAS Biomarker Testing Center Opens in Europe

Merck Serono, the biopharmaceutical business of Merck, has announced that the first liquid biopsy RAS biomarker testing center has opened in Vall d'Hebron's Institute of Oncology, Barcelona, Spain, and will initially test patients as part of its research program. This is an important milestone in making the new liquid biopsy RAS test available to patients with metastatic colorectal cancer (mCRC), and a significant step forward in Merck Serono's collaboration with Sysmex Inostics GmbH,Hamburg, Germany. The ...

Posted on: March 23, 2015
bioLytical's INSTI HIV Assay Receives FDA Approval for HIV-2

bioLytical Laboratories Inc., a leading manufacturer of point-of-care rapid diagnostic tests, has received  FDA approval of its INSTI HIV Antibody Test for use in detecting antibodies to HIV type 2 (HIV-2). With this approval, the INSTI HIV-1/2 Antibody Test is available for use in detecting HIV-1 and HIV-2 antibodies in as little as 60 seconds.The CDC estimates that over 1.2 million persons aged 13 years and older are living with HIV infection in the United States, including over 168,300 (14%) who ...

Posted on: March 22, 2015
GENALICE Releases DNA Data Analysis Solution GENALICE Map On Amazon

Biomedical big data solutions company GENALICE announced that they have added a cloud solution via Amazon Web Services (AWS) to its on-premise solution, the GENALICE VAULT.  Both are deployment options of GENALICE MAP, the company's breakthrough Next-Generation Sequencing (NGS) data processing software. GENALICEMAP processes genomics data up to 100-fold faster than conventional tools and produces improved quality outcome data, while radically reducing the storage ...

Posted on: March 20, 2015
Nearly Half a Million Americans Suffered from Clostridium Difficile Infections in a Single Year

Clostridium difficile (C. difficile) caused almost half a million infections among patients in the United States in a single year, according to a recent study released by the CDC.Approximately 29,000 patients died within 30 days of the initial diagnosis of C. difficile.  Of those, about 15,000 deaths were estimated to be directly attributable to C. difficile infections, making C. difficile a very important cause of infectious disease death in the United States.  More than 80% of the deaths ...

Posted on: March 19, 2015
Alere Receives IVD CE Mark for Alere q HIV-1/2 Detect Assay for POC Molecular Diagnosis of HIV

Alere Inc., a global leader in rapid diagnostic tests, has announced it has received IVD CE marking in Europe for the Alere q HIV-1/2 Detect assay, the first molecular diagnostic at the point of care (POC) that identifies HIV-1 and HIV-2 in less than 60 minutes. Molecular testing of HIV nucleic acids is required for acute detection as well as accurate Early Infant Diagnosis (EID). Current antibody POC tests cannot discriminate between a mother's and infant's antibodies to detect if a newborn has become ...

Posted on: March 18, 2015
Interpace Diagnostics Announces New Data Supporting Use of ThyraMIR with ThyGenX Thyroid Oncogene Panel to Improve Identification of Thyroid Nodules

PDI, Inc. subsidiary Interpace Diagnostics, has announced new data supporting the use of combination platform testing with ThyraMIR, the first and only microRNA expression classifier, and ThyGenX Thyroid Oncogene Panel, a DNA and RNA mutational analysis, to improve thyroid cancer diagnosis. The study, presented at ENDO 2015: The 97th Annual Meeting & Expo of the Endocrine Society held March 5-8, 2015 in San Diego, CA, showed that benign or malignant nodules can be identified with high sensitivity and ...

Posted on: March 17, 2015
Corgenix and Fio Combine Rapid Ebola Test with Automated Analysis and Data Capture to Improve Frontline Care and Case Tracking

Corgenix Medical Corporation and Fio Corporation  announced that they are working together to integrate two technological advances to help end the Ebola outbreak in West Africa: a rapid test, backed by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation, that can detect the virus in minutes; and a mobile device, which is being adapted with further funding from the Gates Foundation, to analyze and upload results directly to a central data system.Fio ...

Posted on: March 16, 2015
Report: Tissue and Cell Diagnostics Market Nears $8 Billion

With fast and effective testing techniques, the tissue and cell diagnostics market was estimated to have reached $7.7 billion in 2014 for in vitro diagnostic (IVD) and other reagents used by clinical laboratories, according to Kalorama Information. Fluorescence in situ hybridization (FISH) was a leading category, according to the healthcare market research publisher. The estimate was made in Kalorama's recent report, The World Market for Tissue Diagnostics and Cell-Based Diagnostics.Speed is a factor in ...

Posted on: March 15, 2015
Roche and BioMed X Collaborate to Develop Nanomaterial-Based Biosensors for Near-Patient Testing

Roche and BioMed X announced today that they have entered into a collaboration agreement to establish a research group focusing on the development of a novel sensor technology platform based on new nanomaterials such as graphene.Outstanding early career scientists from leading academic institutions world-wide are invited to submit original project proposals in the fields of biotechnology, nanotechnology and engineering. Roche and BioMed X will jointly select the best ideas and research talents to form a ...

Posted on: March 13, 2015
A Tool for Studying Broken Chromosomes Becomes a Quality Assurance Asay for Genome Editing

A research team at Boston Children's Hospital's Program in Cellular and Molecular Medicine (PCMM) has developed a quality assurance tool for scientists using genome-editing technologies like the increasingly popular CRISPR. The assay, called high throughput genome translocation sequencing (HTGTS), rapidly gauges--for any given gene--these technologies' accuracy and their risk for causing potentially dangerous genomic collateral damage.The assay's ability to provide such information, the team notes in a ...

Posted on: March 12, 2015
FDA Considers Standards for Next-Generation Sequencing

Recognizing the expanding clinical applications of next-generation sequencing (NGS) and the challenges of overseeing such testing, the FDA recently held a day-long workshop to gather public comment on how best to regulate NGS. An FDA discussion paper released in anticipation of the workshop explains that oversight of NGS testing can be difficult given the ability to sequence the whole genome and identify a potentially unlimited number of variants. The FDA acknowledges it is impractical to ...

Posted on: March 11, 2015
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