
NEW YORK – With recent licensing deals with in vitro diagnostic firms Roche and Beckman Coulter, Alzheimer's testing firm Alzpath has carved out a place at the center of the growing market for blood-based tests for the disease.
The company has licensed its antibody to phosphorylated-tau 217 to the two IVD outfits, part of what President and CEO Chad Holland said is its larger strategy of tackling the Alzheimer's market by supplying global testing firms with the antibodies needed for their diagnostics in the space.
Alzpath does not aim to compete with large diagnostic companies like Roche and Beckman Coulter, Holland said. "We're not interested in that space. We are looking broadly at how we can benefit patients together."
Blood-based testing is a rapidly growing area within Alzheimer's as it could allow clinicians to evaluate patients suspected of having the disease without requiring expensive and invasive PET or cerebrospinal fluid testing — the current standards of care.
P-tau 217 has emerged as a particularly important blood-based marker for Alzheimer's disease as it allows clinicians to assess whether an individual has the amyloid brain pathology characteristic of the condition. Tests for the marker are likely to play a role in qualifying patients for treatment with anti-amyloid therapies, including Eisai and Biogen's Leqembi (lecanemab), which was approved by the US Food and Drug Administration last year, and Eli Lilly's Kisunla (donanemab), which was approved by the FDA this month. Given this, the relative ease and scalability of blood-based testing as compared to PET and CSF tests is likely to become even more important.
A number of laboratory and diagnostic companies have developed or are developing p-tau 217 assays. Quest Diagnostics, Laboratory Corporation of America, C2N Diagnostics, and Quanterix have plasma p-tau 217 laboratory-developed tests (LDTs) on the market. Roche and Beckman Coulter have announced plans to launch plasma p-tau 217 IVDs, licensing the Alzpath antibody for that purpose.
Kathleen Orland, senior VP and general manager of Chemistry and Immunoassay for Beckman Coulter Diagnostics, said that the license agreement with Alzpath was part of a larger move by the company into the blood-based Alzheimer's and neurodegenerative testing space enabled by the release of its DxI 9000 Immunoassay Analyzer. Launched in 2023, the DxI 9000 offers the increased sensitivity required to effectively measure brain-based markers in blood, Orland said. She noted that while the new instrument is intended to cover the company's entire immunoassay portfolio, its sensitivity makes it an "ideal match" for neurology and blood-based neurology assays.
Beckman Coulter is developing the p-tau 217 test in-house at its Chaska, Minnesota, facility using the Alzpath antibody. Orland declined to say what the company's timeline is for submitting the assay to the FDA and bringing it to market.
Beckman Coulter has also partnered with diagnostics firm Fujirebio to develop a blood-based beta-amyloid (Aβ) 42 assay for the DxI 9000.
Orland said the company may either offer the p-tau 217 assay alone or with Aβ42 as a ratio. "We are evaluating both … with regards to diagnosis and separate of [healthy individuals] from patients with disease," she said.
She added that Beckman Coulter is exploring other markers in the Alzheimer's and broader neurodegeneration space, including glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), apolipoprotein E4 (APOE4), Aβ40, and p-tau 181.
Roche, meanwhile, aims to submit its Elecsys PTau217 plasma test to the FDA in 2026. Intended for use in individuals 60 years and older, the assay will be a rule-in test for Alzheimer's and could be used to qualify patients for anti-amyloid treatments or participation in clinical trials. Developed as part of an ongoing collaboration with Eli Lilly, the test received FDA breakthrough device designation in April.
Roche and Eli Lilly are also working on Elecsys plasma tests for p-tau 181 and APOE4 for use in ruling out Alzheimer's disease. The company plans to submit FDA and EU regulatory filings for those tests in 2025. Roche currently offers FDA-cleared tests for CSF Aβ42 and CSF p-tau 181.
Regarding plasma p-tau 217, Bruce Jordan, international business leader of personalized healthcare solutions, neurology and general medicine at Roche, said the company sees it as a potential key marker for guiding treatment with anti-amyloid drugs.
These therapies "will need that definitive presence of amyloid [brain pathology] to be demonstrated in one way or another, and we think that a biomarker like p-tau 217 could play a role in ruling in patients that could have that amyloid pathology," he said.
Holland likewise said Alzpath sees p-tau 217 as "a really important biomarker" in Alzheimer's, and added that the company's p-tau 217 antibody has shown strong performance on large automated immunoassay platforms like those sold by Roche and Beckman Coulter.
Holland took over as Alzpath president and CEO this month, replacing former CEO and Cofounder Venkat Shastri. In a recent interview with 360Dx while he was still CEO, Shastri said the company aims to license its Alzheimer's antibodies widely to diagnostics firms interested in developing Alzheimer's tests while targeting its own tests to the pharma services market.
"Our model is that we have an ecosystem of partners through whom we [offer the antibody]," he said. "If you look at the [IVD] market, installed base-wise, there are about five or six companies who are top dogs. If we get stuck [exclusively] with one, we don't have access [to much of the market]. Our mission is to democratize our assets through as many channel partners as we can."
"We want to make sure that as a small company, whoever wins the fight [for the Alzheimer's testing market], we get a piece of it," he added.
Holland reiterated this strategy and characterized the leadership change as a "cooperative" one driven by the company's shift toward a more commercial focus.
Shastri "has recognized that for the company to grow it needs a new set of skills," he said. "We need commercialization. We need fundraising. We need partnering."
Holland said that while Alzpath does not plan to compete with large diagnostics companies, it is exploring whether there are complementary diagnostics markets it could serve. It also continues to develop additional antibody content in the Alzheimer's and neurodegenerative space that it hopes to license to larger firms.