ALT BioScience, LLC continues to support research efforts on a broad neurodegenerative biomarker in various fluids for future diagnostic platforms and formats across multiple disease states. GS that is released from the brain and liver tissue may be detected in various bodily fluids and is currently being evaluated. The development of the technology has been supported by NIH grants for over 25 years and is based on the detection of an enzyme (glutamine synthetase or GS) that is released from the brain during the progression of Alzheimer?s Disease (AD), Lou Gehrig's disease (ALS) and possibly other neurological diseases. The technology allows for detection of enzyme and protein differences found in serum and cerebrospinal fluid of normal versus diseased subjects. The detection of GS by photoaffinity labeling was reported as a potential diagnostic test for AD and published in the 1992 Proceeding of the National Academy of Science (PNAS).

Glutamine synthetase (GS) detoxifies ammonia and glutamate and is overly expressed after brain impairment. In the AD brain, studies show GS is elevated in cerebral spinal fluid and serum due to its reduced function at nerve connections (synapses). Many researchers worldwide acknowledge the importance of this protein as a potential valid biomarker for Alzheimer?s disease.

ALT BioScience™ is currently co-developing a high sensitivity diagnostic biomarker to detect the increases of GS in serum. It is believed that the detection of GS occurs during early stages of Alzheimer?s disease, which may allow for early diagnosis and treatment, therefore delaying the onset of disease symptoms. This cascade of events starts before the formation of amyloid plaques, which is the main focus of a large portion of research. This formation of plaque starts before mild cognitive impairment occurs, which is the first symptomatic stage of Alzheimer?s disease. Therefore, the detection of increased GS expression may occur in earliest stages.

The University of Kentucky patented the technology and it is exclusively licensed to ALT BioScience™. The PNAS publication led to an increased use of Nucleotide Photoaffinity Labeling Technology as an important research tool for developing diagnostic testing procedures and led other researchers to the confirmation of the Alzheimer's protein as a biomarker to be relatively specific and elevated in only one other neurological disease, Lou Gehrig's or ALS (amyotrophic lateral).

Feasibility studies are currently being evaluated for clinical co-developments. Ongoing research continues to define development opportunities, including neuroscience and other disease state applications.