May 4 Quick Takes: FDA clears Fujirebio’s Alzheimer’s diagnostic 

Adults aged 55 years and older may now be diagnosed with Alzheimer’s Disease using the Lumipulse G β-amyloid Ratio test from Fujirebio Inc., after FDA authorized the first in vitro diagnostic for the disease Wednesday. The test, which offers an alternative to PET imaging, measures the ratio of Aβ42 and Aβ40 concentrations in cerebral spinal fluid (CSF), and must be interpreted in the context of other patient clinical information. In a clinical study of 292 CSF samples, 97% of individuals with a positive Lumipulse G test result had β-amyloid plaques by PET scan and 84% of individuals with negative results did not. While a CSF test gets around the need for certain specialized equipment and radiation exposure, even more accessible, less invasive blood tests are in development. One such test, from C2N Diagnostics LLC, which also measures the Aβ42/40 ratio, is CLIA certified and was launched in 2020. 

New investor Sectoral Asset Management led a $62.5 million series C round for Apnimed Inc. that will allow the biotech to progress lead obstructive sleep apnea program AD109 into Phase III testing. AD109 is a fixed dose combination of norepinephrine reuptake inhibitor atomoxetine and muscarinic receptor antagonist aroxybutynin. New investors Alpha Wave Ventures and NexPoint also participated, alongside existing investors Morningside Ventures, Seligman Investments and Tao Capital Partners. Sectoral’s Stefan Larson, Alpha Wave’s Chris Dimitropoulos and Morningside’s Isaac Cheng will join Apnimed’s board. Cheng replaces Gerald Chan...