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Breaking Down the Regulation of LDTs: Moving Forward

August 4, 2014 3:29 pm | by Richard Park, Contributing Editor | Blogs | Comments

The letter stated that in order to move toward equal regulation, FDA should share its thinking on what it believes LDT regulation under FDCA should look like in practice, or how it plans to deregulate IVDs, by releasing its draft guidance...

Blood and Saliva Tests Help Predict Return of HPV-Linked Oral Cancers

August 4, 2014 3:08 pm | by Johns Hopkins Medicine | News | Comments

Physicians at Johns Hopkins have developed blood and saliva tests that help accurately predict recurrences of HPV-linked oral cancers in a substantial number of patients. The tests screen for DNA fragments of the human papillomavirus (HPV)...

See-Through Organs and Bodies Will Accelerate Biomedical Discoveries

August 4, 2014 2:55 pm | by Cell Press | News | Comments

The ability to see through organs and even the entire body to visualize long-range connections between cells as well as fine-grained cellular structures has been a long-time dream of biologists. A study published by Cell Press July 31st in...

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FDA Clearance of ElMindA’s BNA Analysis System

August 4, 2014 2:24 pm | by ElMindA | News | Comments

ElMindA Ltd. announced today that the United States Food and Drug Administration (FDA) has cleared the company’s BNA Analysis System for the assessment of brain function. Brain Network Activity (BNA) combines non-invasive, multi-channel EEG...

Smartphones as a Health Tool for Older Adults

August 4, 2014 11:02 am | by Universitat Politècnica de Catalunya (UPC) | News | Comments

A team of researchers from the Universitat Politècnica de Catalunya BarcelonaTech (UPC) and the Universitat Autònoma de Barcelona (UAB) is creating a smartphone app that will help older adults to understand their state of health and develop...

Researchers Make Cancer Glow

August 4, 2014 10:43 am | by University of Pennsylvania | News | Comments

The best way to cure most cases of cancer is to surgically remove the tumor. The Achilles heel of this approach, however, is that the surgeon may fail to extract the entire tumor, leading to a local recurrence. With a new technique, researchers...

23andMe Receives Over $1.3 Million in Funding from NIH

August 4, 2014 10:23 am | by 23andMe Inc. | News | Comments

23andMe, the leading personal genetics company, has received from the National Institutes of Health (NIH) a grant totaling $1,367,504 for a two-year project to support the further development of 23andMe's web-based database and research engine...

Tecan Acquires IBL International to Offer Integrated Solution for Specialty Diagnostics

August 4, 2014 10:05 am | by Tecan Group | News | Comments

The Tecan Group has announced the acquisition of IBL International as an important strategic step to support Tecan's evolution into a solutions business with a higher share of recurring revenues. IBL International is a leading company in the...

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U.S. to Remain World’s Leading Diagnostic X-Ray Systems Market by 2020

August 4, 2014 9:36 am | by GlobalData | News | Comments

The U.S. diagnostic X-ray systems market value will grow from $694 million in 2012 to approximately $1.1 billion by 2020, at a moderate Compound Annual Growth Rate (CAGR) of 6.1%, according to research and consulting firm GlobalData. The...

Siemens Unveils New Chemistry and Immunoassay Systems at AACC 2014

August 4, 2014 9:26 am | by Siemens Healthcare | News | Comments

Siemens Healthcare introduces the ADVIA Chemistry XPT System1 and ADVIA Centaur XPT Immunoassay System2 at the 2014 AACC Annual Meeting and Clinical Lab Expo, Chicago, July 27-31. The newest in the company’s portfolio of chemistry and... 

Hope for More Accurate Diagnosis of Memory Problems

August 4, 2014 9:02 am | by University of East Anglia | News | Comments

More accurate tests could be created to diagnose diseases such as Alzheimer's or memory problems stemming from head injuries, leading to earlier intervention, according to new findings from the University of East Anglia (UEA). The research...

Innovative Scientists Update Old-School Pipetting with New-Age Technology

August 4, 2014 8:59 am | by Whitehead Institute for Biomedical Research | News | Comments

A team of Whitehead Institute researchers is bringing new levels of efficiency and accuracy to one of the most essential albeit tedious tasks of bench science: pipetting. And, in an effort to aid the scientific community at large, the group...

FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests

August 4, 2014 8:20 am | by FDA | News | Comments

The U.S. Food and Drug Administration has taken important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results. First, the FDA is issuing a final...

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A blood test for suicide?

July 31, 2014 4:09 pm | by EurekAlert! | News | Comments

Johns Hopkins researchers say they have discovered a chemical alteration in a single human gene linked to stress reactions that, if confirmed in larger studies, could give doctors a simple blood test to reliably predict a person's risk of attempting suicide. The discovery, described online in The American Journal of Psychiatry, suggests that ...

UK psychologist creates patient tool to assist with lung cancer screening decision

July 31, 2014 2:57 pm | by EurekAlert! | News | Comments

The phrase "we caught it early" is possibly the best news a patient can hear in the midst of a cancer diagnosis. Combating cancer in its earliest stages, when the disease is localized to a certain part of the body, gives patients the best chances of survival. Screenings for breast, skin, colon, prostate and other forms of cancer are touted for saving lives through early detection. Many health care providers recommend ...

Potential 'Universal' Blood Test for Cancer Discovered

July 29, 2014 3:10 pm | by EurekAlert! | News | Comments

Researchers from the University of Bradford, UK, have devised a simple blood test that can be used to diagnose whether people have cancer or not. The test will enable doctors to rule out cancer in patients presenting with certain symptoms, saving time and preventing costly and unnecessary invasive procedures such as ...

The LDT Letter Battle

July 28, 2014 9:30 am | by Richard Park, Contributing Editor | Blogs | Comments

Earlier this month, five democratic U.S. Senators sent a letter to the Office of Management and Budget (OMB) regarding the regulation of laboratory-developed tests (LDT). In this letter, Senators Edward J. Markey (D-MA), Richard Blumenthal...

New Chlamydia and Gonorrhea Assays on the BD Viper LT System Receive FDA 510k Clearance

July 28, 2014 9:17 am | News | Comments

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced it has received 510(k) clearance from the U.S. Food and Drug Administration for the BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT System.

Beckman Coulter Diagnostics to Demonstrate Solutions at 2014 AACC Annual Meeting and Clinical Lab Expo

July 25, 2014 11:24 am | News | Comments

Beckman Coulter Diagnostics will be featuring its latest solutions at the 2014 American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo in Chicago, Ill., July 27-31, 2014. The Beckman Coulter Diagnostics booth themed, "New laboratory challenges require new thinking," will showcase

Heart attack patients could be treated more quickly after Manchester research

July 25, 2014 10:47 am | by Manchester University | Product Releases | Comments

Clinical judgement, combined with an electrocardiogram (ECG) and blood test on arrival, is effective in reducing unnecessary hospital admissions for chest pain, a new study shows. The findings of a research group in Manchester, published in the Emergency Medicine Journal, could potentially make a huge difference to a large number of patients.

System anticipates driver fatigue in the vehicle to prevent accidents

July 25, 2014 10:37 am | by Instituto de Biomecánica de Valencia (Biomechanics Institute - IBV) | News | Comments

Instituto de Biomecánica de Valencia (Biomechanics Institute - IBV) has worked on the development of a system with seamlessly integrated smart textiles, able to measure heartbeat and respiratory rate, to prevent driver fatigue and sleepiness at the wheel in the framework of the European project HARKEN.

Gene Changes in Breast Cancer Cells Pinpointed with New Computational Method

July 24, 2014 3:07 pm | by Carnegie Mellon University | News | Comments

Computer scientists at Carnegie Mellon University, working with high-throughput data generated by breast cancer biologists at Lawrence Berkeley National Laboratory, have devised a computational method to determine how gene networks are...

Silicon Technology to Enable a Revolution in Healthcare

July 24, 2014 2:54 pm | by Dr. Liesbet Lagae, R&D Manager Life Science Technologies, imec | Imec | Articles | Comments

Much of the research in healthcare is directed at the major medical challenges of the coming decade. How are we going to cope with the diseases of a growing elderly population, such as brain diseases, cancers, and diabetes? How can we improve...

Test To Screen Donors of Blood, Tissues, and Organs for Hepatitis E Virus Receives CE Mark

July 24, 2014 2:27 pm | by Grifols | News | Comments

Grifols, one of the world’s leading companies in the plasma-derived biological medicines and transfusion medicine sectors, has announced CE mark for the Procleix HEV assay. The test, developed in collaboration with Hologic, Inc. (HOLX)...

FDA 510(k) Clearance for Philips’ Ultra Mobile VISIQ Ultrasound System

July 24, 2014 12:15 pm | by PR Newswire | News | Comments

Royal Philips has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its innovative ultra mobile ultrasound system, VISIQ, in the U.S. VISIQ is the first Philips ultrasound system to combine...

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