A new test for the early detection of Alzheimer’s Disease — potentially even before symptoms are present — show that the diagnostic caught the neurodegenerative disease in 100% of the samples from patients symptomatic for Alzheimer’s.
Researchers at the University of Washington and Seattle biotech startup AltPep are building on a track record of success with their latest publication.
Their study used 265 blood plasma samples from two different organizations and tested them in two different laboratories by different personnel.
The assay detects a certain kind of misformed, clumped protein or “oligomers” that disrupt normal brain function and as Alzheimer’s progresses form larger clumps and plaques. The defective proteins are called Amyloid‑beta (Aβ) toxic oligomers. The test from AltPep is called the Soluble Oligomer Binding Assay (SOBA‑AD).
The research was published Thursday in the journal Nature’s Scientific Reports.
“Ultimately, we want this to be used as a screening device for everybody 40 years of age and up.”
– Valerie Daggett, co-founder and CEO of AltPep
The study builds on earlier successful results with the assay. Two years ago the U.S. Food and Drug Administration (FDA) granted AltPep with a “breakthrough device designation,” conferring a prioritized status for approval for the test.
Valerie Daggett, a UW bioengineering professor and CEO of AltPep, hopes the company can get FDA approval for the assay over the next 12 months and start commercialization.
“Ultimately, we want this to be used as a screening device for everybody 40 years of age and up,” Daggett said.
In addition to the work on the diagnostic assay, the 5-year old startup is also developing a treatment for Alzheimer’s — again targeting the disease as early as possible — and is researching a test and treatment for Parkinson’s disease.
AltPep has raised $76 million from investors and won Health Innovation of the Year at last year’s GeekWire Awards.
The company last week held a grand opening for its new lab, located inside a new life sciences building on Eastlake Avenue that’s part of a growing biotech hub in Seattle’s South Lake Union neighborhood.
The move was a welcome change, Daggett said. The former location “not only was not the greatest lab space, which affected what we could do, but we were space limited,” she said. “So we are really accelerating our programs now and hiring.”
AltPep currently has about 36 employees.
Healthcare providers can detect Alzheimer’s using PET scans, but that technology is suitable for people who have had the disease for perhaps a decade or more and begun forming visible plaques in their brains. Daggett is aiming for earlier detection and treatment in the hope of catching the illness before neurological damage has occurred.
One of the additional advantages of the SOBA-AD test is it’s effective on blood plasma, and does not require cerebrospinal fluid that’s collected through a spinal tap, which carries greater risks and discomfort than a blood draw.
While the new study of the assay identified all of the cases of Alzheimer’s, it also had five false positives among the control samples. These results showed a lower signal of the toxic protein. It’s possible some or all of the five came from patients who were not yet symptomatic for the disease.
Daggett is eager to continue testing her assay against more samples, particularly those with greater racial and ethnic diversity in the patients. The most recent samples were a step in that direction, she said, but not enough.
Still, the results are encouraging.
“It’s fantastic. It’s confirmatory,” Daggett said. “It’s nice to see these things starting to really come together. But on the other hand, you just have to keep doing it. There’s no one test where you go,’OK, done and over.’ You’re constantly proving it.”
Co-authors on the paper are Amy Chen and Dylan Shea.
