CARLSBAD – A local company’s test to detect early signs of Alzheimer’s is closer to becoming available to the public.
Carlsbad-based ALZpath has developed a test that uses an antibody that can determine if the protein phosphorylated tau 217 (pTau217), an indicator of Alzheiemer’s, is in a person’s blood.
A new study has found the tests are highly accurate, and two drug companies recently have partnered with ALZpath to include their test in their platforms, making it available to many people sometime in the future.
While not a cure, early detection of the disease still can be a life safer. The U.S. Food and Drug Administration has approved two drugs to treat Alzheimer’s, but the drugs are most effective if the disease is caught early.
“We’re now entering this new era in human health where we might have treatments or even someday prevention for Alzheimer’s disease,” said ALZpath CEO Chad Holland. “And historically, it’s been really difficult to diagnose Alzheimer’s disease.”
Testing for Disease
The two primary ways of detecting Alzheimer’s have been cerebrospinal fluid (CSF) tests, which require a spinal tap, and positron emission tomography (PET) imaging, which use radiation tracers.
“So you have a radioactive substance that’s introduced in the human body, and is circulating throughout the whole system,” Holland said about PET imaging. “And of course, radiation has increased cancer risk and lots of other things across the board.”
A CSF test requires a lumbar puncture of some kind for a spinal tap, which can be painful and not something many physicians do on a routine basis, he said.
Patients may wait months for the tests, which Holland said can cost thousands of dollars and are not available around the world, while an antibody test can be performed quickly and is expected to cost between $300 and $500.
With Alzheimer’s disease and related dementias affecting 55 million people worldwide and with projections of 140 million by 2050, Holland said there is a pressing need for better early detection. An estimated 75% of patients, including millions with Alzheimer’s disease, are undiagnosed, according to data shared by ALZpath.
In June, ALZpath announced a strategic license agreement with Roche for use of the ALZpath antibody to develop and commercialize an Alzheimer’s disease diagnostic blood test that will be offered on the Roche Elecsys platform.
The FDA recently granted a breakthrough device designation to the Roche pTau217 test that will be part of an ongoing collaboration between Roche and Eli Lilly.
In July, Beckman Coulter Diagnostics signed a licensing agreement with ALZpath to use the antibody in a blood-based in vitro diagnostic test on its DxI 9000 Immunoassay Analyzer.
Holland said the company expects to sign more licensing agreements with other companies.
The next steps for the companies working with the ALZpath antibody are laboratory tests and research before seeking approval as a formal diagnostic test.
“Our mission is to make sure that we democratize access to the antibodies, so people everywhere have access to it around the world, ideally,” Holland said.
How it Works
As Holland explained, the brain has its own local circulation system that includes blood flowing through the heart and lungs for oxidation.
“But there’s something that’s really protective of the brain called blood brain barriers that only lets certain things across one way or the other,” he said. “And a lot of these molecules that we’re talking about called biomarkers, which pTau217 is one, only come across the blood barrier back in really really low concentrations, supper low concentrations.”
A field of academic research has been studying which biomarkers in blood coming from the brain are important, which also has been the mission of ALZpath.
“We’ve been tracking and designing a company to figure out which of these biomarkers that are coming back across blood brain barriers really matter,” Holland said. “And the whole field says pTau217 is what really matters.”
ALZpath has engineered an antibody that binds with pTau217, allowing it to be detected in a blood test.
Holland, who joined the company in July, said the ALZpath test could be used to detect other biomarkers.
“We can think about other antibodies we can develop, and there are other directions we can go out,” he said. “I think we might build a new type of company that hasn’t really existed before and we’re working on some of the details of that.”
Holland stressed that he does not want the company to grow too fast, but at the appropriate rate.
ALZpath
FOUNDED: 2020
HEADQUARTERS: Carlsbad
FOUNDERS: Venkat Shastri, Jerre Stead & Eric Reiman
CEO: Chad Holland
BUSINESS: Biotech company
EMPLOYEES: 14
WEBSITE: www.alzpath.bio
CONTACT: jacob@alzpath.bio
