Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative.

Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced it plans to offer laboratory testing based on the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test from Fujirebio, a global leader in the field of high-quality IVD testing.

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer’s Disease (AD).

Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or dementia.

The National Medical Products Administration (NMPA) has announced the priority review approval for Roche Diagnostics GmbH under its Priority Approval Procedure for Medical Devices (2016 No. 168).

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

A respected organization acclaimed for their groundbreaking work with neurological diseases, C2N Diagnostics, LLC, is partnering with The Michael J. Fox Foundation For Parkinson’s Research (MJFF) to better understand the connections amongst neurodegenerative conditions, Alzheimer’s disease (AD) and neuronal a-synuclein disease (NSD), which encompasses Parkinson’s disease (PD), Lewy body dementia (LBD) and REM behavior disorder (RBD).

The Davos Alzheimer's Collaborative (DAC) announced on Wednesday that it is partnering with Janssen Research & Development and Danaher subsidiary Beckman Coulter Diagnostics to validate blood-based biomarkers for Alzheimer's disease.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Bio-Techne Corporation (NASDAQ: TECH) today announced a strategic partnership with ALZpath, Inc to accelerate breakthroughs in neurodegenerative disease research and treatment, including Alzheimer's disease. The collaboration leverages Bio-Techne's Ella™ fully automated, multiplexing immunoassay platform and ALZpath's proprietary pTau217 antibody to provide the Simple Plex Human Phospho-Tau (T217) ALZpath Assay.