Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has received approval from the Hainan Medical Products Administration for its suite of Alzheimer’s disease (AD) cerebrospinal fluid diagnostic kits. The approved products include Elecsys β-Amyloid (1-42) CSF II, Elecsys Phospho Tau (181P) CSF, Elecsys Total Tau CSF detection reagents, along with compatible calibration solutions and quality control products, totaling nine items. These innovative diagnostic tools will be deployed at Shanghai Ruijin Hospital’s Hainan subsidiary.
These clinically urgent imported medical devices mark a first in China, offering the ability to quantitatively measure key biomarkers associated with Alzheimer’s disease in cerebrospinal fluid. The kits can assess cognitive impairment by evaluating the concentrations of β-amyloid protein (1-42) (Aβ-42), phosphorylated Tau protein (P-Tau), and total Tau protein (T-Tau). Their use extends to not only diagnosing Alzheimer’s disease but also to risk-stratifying patients with mild cognitive impairment, distinguishing those at low and high risk of further cognitive decline.- Flcube.com
