Three new immunoassays targeting key neurodegeneration biomarkers require just 1 µL of plasma and run on standard laboratory instruments.

Spear Bio has introduced three new ultrasensitive immunoassays designed to advance blood-based biomarker testing for Alzheimer’s disease and Parkinson’s disease, debuting the products at the International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD 2026) in Copenhagen last week.

The new SPEAR UltraDetect immunoassays target brain-derived phosphorylated tau 217 (BD-pTau 217), α-synuclein (α-syn), and phospho-Ser129-α-synuclein (pS129-α-syn)—protein biomarkers associated with neurodegenerative proteinopathies. The product launches coincide with the Woburn, Mass.-based company’s establishment of direct-to-customer operations in both North America and Europe.

BD-pTau 217: Detecting Alzheimer’s at the Preclinical Stage

The SPEAR UltraDetect BD-pTau 217 Assay was first released to early adopters last month and is described by the company as the only brain-derived pTau 217 test to achieve 100% quantifiability in both healthy and diseased plasma samples, according to a release. Operating in a homogeneous, wash-free format, the assay requires just 1 µL of diluted plasma, achieves a functional lower limit of quantification of 25 fg/mL, and an average intra-plate coefficient of variation of 5.7%.

According to the company, those performance characteristics allow investigators to detect Alzheimer’s disease–related tau changes at the preclinical stage while conserving sample volume for longitudinal studies—a critical consideration for researchers managing limited biobanked specimens.

“Our goal is to place the most sensitive protein biomarker tools in the hands of scientists tackling complex neurodegenerative diseases,” says Feng Xuan, founder and chief executive officer of Spear Bio, in a release. “By expanding our assay portfolio and transitioning to direct customer engagement, we are empowering researchers to generate higher-quality data with greater efficiency, accelerating the path from discovery to clinical impact.”

New Assays Target Parkinson’s and Related Synucleinopathies

Alongside the BD-pTau 217 offering, the newly introduced α-syn and pS129-α-syn assays are designed to address biomarker detection needs in Parkinson’s disease and related synucleinopathies. Both kits quantify monomeric, oligomeric, and post-translationally modified synuclein species at low-femtogram concentrations using only 1 µL of diluted sample, according to the company.

The platform is compatible with widely available quantitative polymerase chain reaction instruments, eliminating the need for proprietary readers.

“SPEAR UltraDetect delivers attomolar sensitivity using just 1 µL of sample,” says Oliver Tassinari, vice president of business development and strategy at Spear Bio, in a release. “For researchers working with precious biobanked samples, low sample volume requirement means richer data from more assays without depleting samples.”

Direct Access and Conference Presence

The product launches come alongside Spear Bio’s move to direct-to-customer operations—a structural shift the company says will streamline access to its technology for laboratories investigating neurodegenerative diseases. Previously reliant on distribution partners, the new model covers both North American and European markets.

Spear Bio served as an official sponsor of AD/PD 2026, presenting new validation data across multiple poster sessions and hosting a product theater on March 21 at the Bella Center in Copenhagen.

The assay introductions come amid growing momentum in the blood-based biomarker space for Alzheimer’s diagnosis. Last year, the Alzheimer’s Association released its first clinical practice guideline recommending the use of blood-based biomarker tests—including plasma phosphorylated tau 217 (p-tau217)—as both triaging and confirmatory tools in patients with objective cognitive impairment presenting in specialized memory-care settings. The guideline specifies that qualifying tests must meet sensitivity and specificity thresholds of at least 90% and 75%, respectively, for triage use, or 90% for both metrics when used as a confirmatory test. Several commercial p-tau217 tests are now in various stages of regulatory review or active clinical use.

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