Spear Bio unveils SPEAR UltraDetect, a new ultrasensitive immunoassay platform targeting neurology biomarkers

Spear Bio, a Massachusetts-based biotechnology firm, launched its next-generation homogeneous immunoassay platform—SPEAR UltraDetect—on July 25, 2025, aiming to transform research into neurodegenerative diseases. The initial rollout includes assays for four key neurology biomarkers: phosphorylated tau 231 (pTau231), phosphorylated tau 217 (pTau217), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL). Global distribution of the product will be managed through a partnership with Bio-Techne.

The SPEAR UltraDetect platform was designed to address limitations in traditional immunoassay formats. While most current ultrasensitive methods rely on heterogeneous approaches requiring solid surface binding and multiple wash steps, Spear Bio’s proprietary platform is the first homogeneous immunoassay system to achieve attomolar-level sensitivity without the need for washing. This innovation enables rapid, precise, and scalable biomarker quantification from minimal blood volumes—down to one microliter of diluted sample.

What is SPEAR UltraDetect and how does it differ from legacy technologies?

The SPEAR UltraDetect platform introduces a wash-free, solution-phase detection method that eliminates several bottlenecks found in conventional ultrasensitive assays. These conventional assays are typically constrained by solid-phase immobilization, which not only limits the assay’s scalability but can also introduce background signal and non-specific binding.

Spear Bio’s technology integrates a two-factor authentication mechanism that ensures signal detection occurs only when both antibody pairs remain co-localized on a target biomolecule for a sustained duration. This approach significantly reduces the rate of false positives, which has been a persistent challenge in heterogeneous immunoassay formats. The system also demonstrates compatibility with widely available quantitative PCR (qPCR) instrumentation, offering highly reproducible results across different platforms and lab environments.

According to the company, SPEAR UltraDetect enables consistent detection of low-abundance neurological markers—particularly critical when working with blood samples, where target proteins are often present in trace concentrations due to the restrictive properties of the blood-brain barrier.

Why these four neurology biomarkers matter in current research

The four biomarkers featured in the launch—pTau231, pTau217, GFAP, and NfL—are widely recognized as critical indicators in the pathology of Alzheimer’s disease and related neurodegenerative conditions.

Phosphorylated tau proteins, particularly pTau217 and pTau231, have shown promise as early indicators of Alzheimer’s disease progression. Elevated levels of these proteins are associated with tauopathy and neuronal damage. GFAP is a structural protein of astrocytes, often elevated in response to neuroinflammation. NfL is a marker of axonal damage and is emerging as a reliable indicator of disease progression in disorders like ALS, multiple sclerosis, and traumatic brain injury.

The ability to detect these markers with attomolar precision from peripheral blood rather than cerebrospinal fluid (CSF) could significantly ease biomarker testing, making longitudinal tracking and early diagnosis more accessible and less invasive.

Clinical and research applications for SPEAR UltraDetect

Spear Bio emphasized that SPEAR UltraDetect’s sensitivity, precision, and compatibility with standard lab equipment position it as a valuable tool in both academic and clinical research settings. By offering a homogeneous format, the platform simplifies integration into high-throughput screening workflows and routine diagnostic pipelines.

This capability could be particularly important for large-scale clinical trials evaluating disease-modifying therapies for Alzheimer’s and other neurodegenerative diseases. Blood-based biomarker quantification enables more frequent and less burdensome monitoring, which can enhance data resolution and patient compliance.

In research labs, where reproducibility and scalability are critical, SPEAR UltraDetect’s uniform performance across multiple qPCR platforms reduces variability and increases confidence in longitudinal biomarker data.

Event showcase and market timing

Spear Bio will present SPEAR UltraDetect at the 2025 Alzheimer’s Association International Conference (AAIC), scheduled for July 27–30 in Toronto. The company will exhibit at Booth #1527, showcasing the platform to neurologists, biopharma researchers, and diagnostics developers.

The timing of the launch aligns with heightened interest in blood-based biomarkers for neurodegenerative disease monitoring. Over the past two years, multiple FDA-cleared diagnostics have entered the market leveraging markers like pTau and NfL. These include blood tests from C2N Diagnostics and Quanterix, among others. However, many of these tools still rely on heterogeneous immunoassays or require proprietary hardware systems. SPEAR UltraDetect’s ability to function on commonly used qPCR platforms could lower barriers to adoption and open access to a wider range of users.

Industry positioning and collaborative distribution

Spear Bio’s collaboration with Bio-Techne signals a strategic move to accelerate commercial adoption and scale manufacturing capacity. Bio-Techne, a global supplier of life sciences tools and reagents, will help distribute the SPEAR UltraDetect assays worldwide. This partnership may also serve to validate the platform’s scalability and expand its availability to clinical labs and translational research centers globally.

Feng Xuan, PhD, Co-founder and CEO of Spear Bio, described the platform as “the first of its kind ultrasensitive immunoassay solution” to directly address the long-standing challenges in detecting low-abundance neurology biomarkers from blood. He stated that the solution would empower both academic and clinical researchers to improve diagnostics and treatment development for neurological disorders.

What this launch could mean for neurology research advancement

The commercial availability of a homogeneous, ultra-sensitive immunoassay like SPEAR UltraDetect™ could mark a pivotal advancement in the toolkit available to neurological researchers. By addressing the twin barriers of sensitivity and operational complexity, the platform provides a more accessible solution for labs that have historically lacked the infrastructure for complex heterogeneous assays. This democratization of technology has the potential to shift the current paradigm, allowing researchers in community hospitals, regional clinics, and smaller academic institutions to participate in cutting-edge biomarker studies with greater accuracy and efficiency.

Moreover, as global health systems increasingly move toward proactive and preventive models, especially in neurodegenerative disease care, the demand for minimally invasive, blood-based diagnostics is expected to rise. Platforms such as SPEAR UltraDetect are well-positioned to support these evolving care models by enabling earlier detection, real-time disease monitoring, and more nuanced stratification of patient populations for clinical trials. Its compatibility with standard qPCR systems not only facilitates cost-effective implementation but also broadens its utility in biobanks, population studies, and resource-constrained settings.

Industry analysts note that widespread access to high-quality biomarker data may accelerate the development of precision neurology approaches, where therapeutic interventions can be tailored based on a patient’s unique biomarker profile. While broader clinical adoption will depend on long-term validation studies, regulatory reviews, and health economics assessments, the scientific infrastructure provided by SPEAR UltraDetect signals a strong foundation for the next decade of innovation in neurological diagnostics and translational medicine. If adopted at scale, it could serve as a catalyst for collaborative biomarker-driven research initiatives and help bridge the translational gap between benchside discovery and bedside application.