A Carlsbad company has developed a blood test that can be used for the early detection of Alzheimer’s disease.
The blood test ALZpath, Inc. has developed detects the presence of phosphorylated tau 217 (pTau217) in blood – a protein that is an indicator of Alzheimer’s disease, said Venkat Shastri, a founder, director, and CEO of ALZpath.
Formed in 2020, ALZpath is a virtual company with most of the company’s 11 employees scattered across the country working remotely, Shastri said.
The company contracts out any lab work it needs to be done, using labs in the U.S. and Europe, Shastri said.
The new test can tell well before other methods of testing if someone is developing Alzheimer’s, Shastri said, giving them time to adjust lifestyle habits that can delay or help mitigate the debilitating effect of the disease.
“Large case studies say that if you simply change your lifestyle habits, you eat less fatty foods, less carbohydrates, less sugar, workout more, read more, that pushes the cognitive decline from three to five years out,” Shastri said.
Once someone has been diagnosed with Alzheimer’s, it moves quickly. In three to five years, someone can go from being completely independent to being completely dependent, Shastri said.
With treatments for Alzheimer’s in the works, early detection is more critical than ever, Shastri said.
“You can start treatment sooner. You can also can find out which patients can be most benefitted by the treatment,” Shastri said. “You want to have a screening tool.”
Beyond helping to determining if someone has Alzheimer’s, Shastri said the blood tests can help monitor the effectiveness of treatments.
“For all stages of treatment, we need blood tests and with very good diagnostic accuracy,” Shastri said. “We are launching something that hopefully will satisfy many of those requirements.”
A challenge in developing blood tests for Alzheimer’s is that because of a brain blood barrier, only a fraction of the proteins ever make it into the blood, Shastri said.
Company officials presented analytic and initial clinical performance data on the test at the Clinical Trials in Alzheimer’s Disease Conference in late November in San Francisco.
The company’s tests are already available for use in research studies and Shastri said the goal is to have them approved for clinical trials in 2023.
“By the end of 2024, the mission of the company is to see if it could be available in every hospital network, that’s the mission of the company,” he said.
“We are basically preparing the marketplace for all the drugs that are going to come on the market in the next five years,” Shastri added.
Shastri said that he chose Carlsbad as the company’s headquarters because he lives in Carlsbad and San Diego County “is a better area for recruitment” for biotech companies because of its talent pool.
When the company started, there were just the three founders.
“We actually didn’t pay ourselves. We had day jobs,” said Shastri, who is chairman of the Department of Electrical Engineering and De Sanctis Professor of Engineering & Entrepreneurship at the University of San Diego.
“We are highly dedicated people who believe in the mission,” Shastri said.
Doing it Right
While most biotech companies have their own labs and require workers to be in the lab or office at least part time, Shastri said ALZpath will continue to operate virtually for the foreseeable future — but that could change long term as the company grows.
“I’m getting talent that’s at the highest level when I give them this flexibility. I really want to go as far as I can with this model,” Shastri said. “It’s not about how big we can be. It is about doing it right and actually executing correctly so that it scales up and it’s useful in the marketplace.”
Founders: Venkat Shastri, Jerre Stead and Eric Reiman
Business: Biotech company
Notable: ALZpath operates virtually, with employees working remotely from scattered locations across the U.S.