Topic:

Diagnostics

Latest Headlines

Latest Headlines

Biomarker could improve early rheumatoid arthritis diagnosis

A novel biomarker could make it easier for physicians to diagnose rheumatoid arthritis early, thereby improving patients' prospects. The best results come when conventional antibody testing is combined with the new biomarker.

Survey says people want neurological diagnosis, regardless of cure

The argument for the importance of patient diagnosis often relies upon the efficacy of subsequent treatment. But according to a recent study, three-quarters of people would want to know if they have a particular neurological disorder even if it had no cure.

Cheap, portable Dx device detects an array of medical and environmental conditions

Harvard researchers have developed an inexpensive handheld device for use in the world's poorest regions that can monitor diabetes, detect malaria and analyze drinking water through electrochemical analysis and then send the information to a computer anywhere on the globe by standard mobile phone.

Abbott gets $20M from DOD to develop portable concussion test

Abbott Laboratories and the United States Department of Defense are collaborating to develop a test that can be used to assess potential concussions quickly in the field. Abbott's handheld diagnostic i-Stat System is already in use by the military; the test will be developed for use on it.

Foundation Medicine teams with MD Anderson for new trial of cancer Dx

Foundation Medicine is teaming up with the MD Anderson Cancer Center in Texas for a new trial of the the Cambridge, MA-based company's molecular diagnostic cancer test that targets therapies matched to individual patients.

UCLA researchers develop wearable biosensor for detecting GI disorder postsurgery

Researchers have developed a device that could determine how soon patients should be fed following surgery. Patients with the intestinal problem postoperative ileus fall sick if they eat too soon after surgery and must stay in the hospital for an additional two to three days.

Four unanswered questions about the looming LDT regulations

The FDA described the contents of its proposed regulatory framework to Congress, but the details of its plan remain a mystery. Following the July 31 notification to Congress, the agency must wait at least 60 days before the release of its draft guidance on the topic.

Scientists work toward faster, easier, cheaper Ebola diagnostics

While test strips and expensive polymerase chain reaction (PCR) machines exist in the Ebola detection market, scientists are after a medical device that can detect and prevent the spread of Ebola at a low cost.

Nanopores, microfluidics get $14.5M from NIH for new DNA sequencing tech

The National Institutes of Health (NIH) has awarded $14.5 million in eight grants to researchers working to develop high quality and low cost DNA sequencing. The grants are each for two to four years and are awarded through the Advanced DNA Sequencing Technology program of the National Human Genome Research Institute, a part of NIH.

UPDATED: FDA announces intention to comprehensively regulate lab-developed tests

FDA announced July 31 that it intends to issue a draft guidance soon that would require moderate and high-risk diagnostics to obtain 510(k) or PMA approval, regardless of their place of origin, putting an end to a battle to regulate laboratory-developed tests that's been waged for several years.