It’s game time for Abbott Laboratories’ 15-minute concussion test now that FDA clearance is in hand. The I-Stat traumatic brain injury cartridge uses whole blood, allowing bedside assessment of patients without lab processing.
Exact Sciences Corp. reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including Barrett’s esophagus.
Scientists from Abbvie Deutschland GmbH & Co. KG and Abbvie Inc. have identified radiolabeled compounds capable of imaging and targeting microtubule-associated protein Tau (PHF-tau; MAPT) aggregates acting as positron emission tomography (PET) imaging agents reported to be useful for the diagnosis of progressive supranuclear palsy.
Researchers from Massachusetts General Hospital recently detailed the discovery of [11C]SY-08, a new PET radiotracer that detects aggregated α-synuclein (α-Syn) fibrils in individuals with neurological disorders such as Parkinson’s disease, multiple system atrophy and dementia with Lewy bodies.
The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot.
An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC.
Laboratory Corporation of America Holdings expanded its blood biomarker test portfolio for Alzheimer’s disease, making its pTau217 test available by prescription in the U.S. as well as for research globally. The standalone test can also be used in monitoring patients undergoing treatment for the neurodegenerative disease.
Researchers from the University of Stellenbosch in South Africa are seeking protection for a simple and user-friendly point-of-care device for diagnosing tuberculosis. Their electrochemical lateral flow device merges lateral flow device technology and electrochemical device technology by using porous electrodes that are capable of transporting electrolytic liquid and fluid sample.
In what represents their first patenting, a researcher from the University of California is seeking protection for non-invasive methods of brain monitoring that use electroencephalography (EEG) to detect new or worsening brain injury in pediatric patients.
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