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CHLA, House Research Institute receive FDA approval to begin pediatric ABI clinical trial

L.A.-based House Research Institute and Children's Hospital Los Angeles announced today that the United States Food and Drug Administration (FDA) has given final approval to begin a clinical trial of an Auditory Brainstem Implant (ABI) procedure for children.

22 Jan 2013

PathCentral announces roll-out of new pathology network

PathCentral, a technology-enabled company dedicated to the success of the international pathology community, and China-based Kindstar Globalgene Technology, Inc., today announced the roll-out of the PathCentral Pathology Network, an online professional pathology network that will enable Kindstar to access US pathologists and facilitate pathology consultations for more than 3,300 hospitals throughout China.

22 Jan 2013

Researchers identify and test first blood-based circulating miRNA biomarkers for Parkinson's

Parkinson's disease (PD) is a progressive neurological condition. At present, it is usually diagnosed only when motor features are present. Hence, there is a need to develop objective and measurable biomarkers to improve PD diagnostics during its earlier stage, prior to its motor onset. In this pilot study, researchers identified and tested the first blood-based circulating microRNA (miRNA) biomarkers for PD.

21 Jan 2013

FDA approves Protein Sciences’ Flublok to prevent seasonal influenza

The US Food and Drug Administration has approved Protein Sciences Corporation's vaccine Flublok for the prevention of seasonal influenza in adults 18 to 49 years of age. Diamyd Medical holds about 8 percent of the shares in Protein Sciences Corporation.

18 Jan 2013

Life Technologies, ASU partner on new project to quickly measure radiation exposure

Arizona State University's Biodesign Institute- has announced a partnership with Life Technologies Corporation as it enters the next phase of a multi-million-dollar, multi-institutional research project to develop a medical device to rapidly assess an individual's exposure to radiation in the event of a nuclear incident.

18 Jan 2013

FDA clears Sanovas’ Vas Zeppelin Smart Catheter to treat chronic pulmonary diseases, lung cancer

Sanovas Inc., a life science technology company developing and commercializing the next-generation of micro-invasive diagnostics, devices and drug delivery technologies, announced today that it has filed with the U.S. Food and Drug Administration for clearance of the company's Vas Zeppelin Smart Catheter for the treatment of chronic pulmonary diseases and lung cancer.

17 Jan 2013

FDA categorizes Cepheid's Xpert CT/NG test as 'Moderate Complexity' under CLIA

Cepheid today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert CT/NG test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA).

17 Jan 2013

FDA approves St. Jude Medical’s Merlin.net Patient Care Network

St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval of the next-generation Merlin.net Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

17 Jan 2013

Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA).

17 Jan 2013

Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations.

17 Jan 2013

New method based on mass sequencing can detect hereditary breast and ovarian cancer syndrome

Researchers of the Catalan Institute of Oncology (ICO) at the Bellvitge Biomedical Research Institute (IDIBELL) have developed and validated a new method to diagnose hereditary breast and ovarian cancer syndrome based on mass sequencing of BRCA1 and BRCA2 genes. The model is based on a genetic and bioinformatic analysis which has been proved very effective.

17 Jan 2013

Thermo Scientific QMS Everolimus Assay Kit receives CE Mark for liver transplant application

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its Thermo Scientific QMS Everolimus Assay Kit has been CE marked for sale in the European Union for a third application, namely liver transplants.

From Thermo Fisher Scientific Inc. 16 Jan 2013

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

GE Healthcare today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.

16 Jan 2013

Zimbabwe continues to face medicine shortages, stock-outs, PlusNews reports

"Chronic shortages of generic and antiretroviral drugs, stock-outs, high medication costs, and long distances to clinics are some of the hurdles people face in their quest to access essential medicines in Zimbabwe," PlusNews reports.

16 Jan 2013

Thermo Fisher's expandable portfolio of lab automation solutions to be showcased at SLAS 2013

Thermo Fisher Scientific Inc., the world leader in serving science, today introduced a new range of laboratory automation and screening solutions during the Second Annual Society for Laboratory Automation and Screening (SLAS) conference and exhibition.

From Thermo Fisher Scientific Inc. 16 Jan 2013

Thermo Scientific VisionTracker database software to be showcased at SLAS 2013

Thermo Fisher Scientific Inc., the world leader in serving science, today introduced the new Thermo Scientific VisionTracker database software for more accurate and efficient management, tracking and retrieval of laboratory samples. VisionTracker will be showcased this week at Society for Laboratory Automation and Screening (SLAS) 2013, Gaylord Palms Resort and Convention Center, January 12-16, 2013, Booth #807.

From Thermo Fisher Scientific Inc. 15 Jan 2013

FDA clears Hologic's APTIMA Trichomonas vaginalis Assay

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing its APTIMA Trichomonas vaginalis Assay on the Company's fully-automated PANTHER System.

From Hologic, Inc. 15 Jan 2013

Scientists develop playbook to end devastating impact of fibrotic diseases

A team of scientists has developed a playbook for ending the devastating impact of fibrotic diseases of the liver, lung, kidney, and other organs, which are responsible for as many as 45 percent of all deaths in the industrialized world.

11 Jan 2013

Johns Hopkins develops PapGene test to diagnose ovarian and endometrial cancers

Using cervical fluid obtained during routine Pap tests, scientists at the Johns Hopkins Kimmel Cancer Center have developed a test to detect ovarian and endometrial cancers. In a pilot study, the "PapGene" test, which relies on genomic sequencing of cancer-specific mutations, accurately detected all 24 (100 percent) endometrial cancers and nine of 22 (41 percent) ovarian cancers. Results of the experiments are published in the Jan. 9 issue of the journal Science Translational Medicine.

11 Jan 2013

UMDNJ develops rapid detection test for Exserhilum rostratum

A rapid detection test for Exserhilum rostratum, the fungus primarily responsible for 39 deaths among patients injected last year with a contaminated steroid medication, has been developed by a research team led by David S. Perlin, PhD, Executive Director of the Public Health Research Institute (PHRI) at the University of Medicine and Dentistry of New Jersey-New Jersey Medical School.

10 Jan 2013

Diagnostics News and Research

CHLA, House Research Institute receive FDA approval to begin pediatric ABI clinical trial

PathCentral announces roll-out of new pathology network

Researchers identify and test first blood-based circulating miRNA biomarkers for Parkinson's

FDA approves Protein Sciences’ Flublok to prevent seasonal influenza

Life Technologies, ASU partner on new project to quickly measure radiation exposure

FDA clears Sanovas’ Vas Zeppelin Smart Catheter to treat chronic pulmonary diseases, lung cancer

FDA categorizes Cepheid's Xpert CT/NG test as 'Moderate Complexity' under CLIA

FDA approves St. Jude Medical’s Merlin.net Patient Care Network

Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Astellas announces FDA acceptance of Tarceva sNDA for EGFR activating mutation-positive NSCLC

New method based on mass sequencing can detect hereditary breast and ovarian cancer syndrome

Thermo Scientific QMS Everolimus Assay Kit receives CE Mark for liver transplant application

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

Zimbabwe continues to face medicine shortages, stock-outs, PlusNews reports

Thermo Fisher's expandable portfolio of lab automation solutions to be showcased at SLAS 2013

Thermo Scientific VisionTracker database software to be showcased at SLAS 2013

FDA clears Hologic's APTIMA Trichomonas vaginalis Assay

Scientists develop playbook to end devastating impact of fibrotic diseases

Johns Hopkins develops PapGene test to diagnose ovarian and endometrial cancers

UMDNJ develops rapid detection test for Exserhilum rostratum

Industry Focus eBook - Biotechnology (4th edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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