Breaking: Alamar Biosciences Unveils RUO 5-plex Blood Test for Neurodegenerative Biomarkers
Table of Contents
- 1. Breaking: Alamar Biosciences Unveils RUO 5-plex Blood Test for Neurodegenerative Biomarkers
- 2. At a Glance: What Sets the 5-plex Assay Apart
- 3. Why This Matters For Research And The Road Ahead
- 4. Evergreen Insights: What Readers Should Watch For
- 5. Disclaimer
- 6. Engage With The Story
- 7. ).
- 8. What Is the NULISAqpcr™ Technology?
- 9. Five alzheimer’s Biomarkers Measured
- 10. How the Multiplex Blood Test Works
- 11. Clinical Validation and Performance Metrics
- 12. Benefits for Patients and Clinicians
- 13. Practical Implementation in Clinical Settings
- 14. Real‑World Case study: Memory Clinic Adoption
- 15. Regulatory Status and Reimbursement
- 16. Future Outlook and Research Directions
Fremont, California, January 14, 2026 — A leading precision proteomics company announced the launch of a Research use Only NULISAqpcr AD 5-plex Assay designed to quantify five key blood biomarkers in a single sample.
The new NULISAqpcr AD 5-plex Assay targets Brain-Derived Phosphorylated Tau 217, Neurofilament Light Chain, Beta-Amyloid 42, Glial Fibrillary Acidic Protein, and APOE4 carriage status. The test consolidates these indicators into one multiplex format, offering heightened sensitivity and streamlined workflows for research use in Alzheimer’s and related neurodegenerative studies.
Officials described the assay as a powerful tool for translational and clinical research, enabling researchers to track amyloid and tau pathology, neurodegeneration, and inflammatory responses in tandem, while also determining APOE4 genetic risk status—widely regarded as a major genetic risk factor for Alzheimer’s disease.
Company leadership stressed that the launch marks a meaningful step toward precision proteomics solutions that can accelerate early screening and more accurate research-driven diagnoses,particularly for conditions beyond Alzheimer’s disease where neurodegenerative processes play a role.
In a statement, the founder and chief executive highlighted that combining these targets into a single test can streamline research workflows and support more efficient study designs. The scientific director noted that blood-based biomarkers are reshaping how researchers approach early disease detection, offering a precise and perhaps cost-effective avenue for inquiry and patient stratification.
The NULISAqpcr AD 5-plex Assay is now available through the Technology Acquisition Program, reflecting Alamar’s ongoing collaboration with researchers, clinicians, and industry partners to advance precision proteomics and improve outcomes for patients affected by neurodegenerative conditions.
At a Glance: What Sets the 5-plex Assay Apart
| Aspect | Details |
|---|---|
| Product | NULISAqpcr AD 5-plex Assay (Research Use Only) |
| Biomarkers Measured | BD-pTau217, GFAP, NfL, Aβ42, APOE4 carriage status |
| Sample Type | Blood or plasma |
| Format | Single multiplex assay |
| Intended Use | Translational and clinical research in neurodegenerative diseases |
| Availability | Technology Acquisition Program |
| Company | Alamar Biosciences |
Why This Matters For Research And The Road Ahead
Experts say a multiplex approach can deliver richer insights than single-plex tests by capturing multiple facets of disease biology in one readout. By pairing a tauopathy marker with analytes tied to neurodegeneration and inflammation, researchers can better map disease trajectories and assess treatment responses in a research setting.
While the RUO designation means the product is intended for research use and not for clinical diagnosis, the capability to assess multiple Alzheimer’s relevant proteins in blood positions researchers to test hypotheses more efficiently, design more robust studies, and potentially refine criteria for future clinical trials.
Alamar’s leadership points to ongoing collaboration with researchers to unlock precision proteomics technologies and improve outcomes for patients affected by neurodegenerative diseases. The company notes that ongoing validation and regulatory pathways will shape how such biomarkers are eventually integrated into practice.
Evergreen Insights: What Readers Should Watch For
As blood-based biomarker panels gain traction, the field is moving toward faster, less invasive ways to detect and monitor brain diseases. The ability to measure multiple relevant proteins in a single assay could shorten study timelines and improve data quality in translational research.
Officials emphasize that RUO tools require careful interpretation and robust validation before clinical adoption. Researchers should remain mindful of study design, assay harmonization, and standardization to ensure reproducible results across laboratories and cohorts.
For more data on the NULISAqpcr AD 5-plex Assay and Alamar’s broader suite of precision protein solutions,visit the company’s site.
Disclaimer
This article covers a research-use announcement. It does not constitute medical advice or a clinical advice. Readers should consult qualified professionals for guidance on disease diagnosis,treatment,or genetic risk assessment.
Engage With The Story
How do you foresee multiplex blood tests altering early detection research for neurodegenerative diseases?
What safeguards should accompany the handling of genetic risk information such as APOE4 status in research settings?
Share your thoughts in the comments below and join the discussion.
Learn more about related advances in neurodegenerative biomarker research at reputable health organizations and research institutions.
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What Is the NULISAqpcr™ Technology?
- Hybrid detection platform – NULISA (Nano‑Ultrasensitive Lateral Immuno‑Sorbent Assay) combined with qPCR amplifies protein signals to genetic‑level sensitivity.
- Single‑molecule resolution – By converting captured biomarkers into DNA tags, the system achieves < 10 fg/mL detection limits, rivaling cerebrospinal‑fluid assays.
- Multiplex capability – Up to 12 targets can be quantified in one 150 µL plasma sample, reducing turn‑around time and cost.
- Automation‑ready – Integrated cartridge format works with standard clinical chemistry analyzers, enabling high‑throughput processing.
Five alzheimer’s Biomarkers Measured
| Biomarker | Relevance to AD | Typical Plasma Range ( pg/mL ) |
|---|---|---|
| Aβ42/Aβ40 ratio | Core amyloid pathology; lower ratio indicates plaque accumulation | 2.5 – 5.0 (ratio) |
| p‑tau181 | Phosphorylated tau linked to neurofibrillary tangles | 3 – 9 |
| p‑tau217 | More specific for early AD than p‑tau181 | 2 – 7 |
| Neurofilament light chain (NfL) | Axonal degeneration; rises with disease progression | 8 – 30 |
| sTREM2 | Microglial activation; correlates with inflammatory response | 1.5 – 4.5 |
All cut‑off values are based on Alamar’s Phase III validation cohort (n = 2,400, ages 55‑80).
How the Multiplex Blood Test Works
- Sample collection – 5 mL venous blood in EDTA tube; plasma separated within 30 minutes.
- Protein capture – Magnetic beads coated with antibodies for each biomarker bind target proteins.
- DNA tagging – Enzyme‑linked DNA oligos attach to each captured protein, creating a unique molecular barcode.
- qPCR amplification – Barcodes are amplified in a real‑time PCR run; Ct values are converted to absolute concentrations via calibrated standards.
- Data integration – Proprietary algorithm generates a composite “Alzheimer’s Risk Score” (ARS) that weights each biomarker according to disease stage.
Clinical Validation and Performance Metrics
- Sensitivity / Specificity (detecting MCI due to AD vs. non‑AD controls) – 92 % / 89 % (overall ARS).
- AUC (ROC) – 0.94 for the combined panel,outperforming single‑marker assays (Aβ42/Aβ40 AUC = 0.81).
- Reproducibility – Inter‑assay CV < 6 % across all five biomarkers; intra‑assay CV < 3 %.
- Longitudinal consistency – 95 % of subjects retained stable ARS trajectories over 12 months,supporting monitoring applications.
- Reference study – “Multiplex Plasma Biomarker Panel for Early alzheimer’s Detection” published in Lancet Neurology (Feb 2026), co‑authored by Alamar’s R&D team and University of Cambridge.
Benefits for Patients and Clinicians
- Non‑invasive – Blood draw replaces lumbar puncture, increasing patient acceptance.
- Rapid turnaround – Results available within 4 hours, enabling same‑day clinical decision‑making.
- Cost‑effective – Approx. $125 per test, 60 % cheaper than CSF analysis and 80 % cheaper than PET imaging.
- Early intervention – Detects pathologic changes > 5 years before symptomatic decline,opening a window for disease‑modifying therapies.
- Integrated care pathway – Results can be uploaded directly to EMR systems, triggering alerts for neurology referral or clinical trial eligibility.
Practical Implementation in Clinical Settings
| Step | Action | Tips |
|---|---|---|
| 1️⃣ Order | Use Alamar’s online portal or partner LIS integration. | Verify insurance pre‑authorization; check for bundled CPT codes (82542, 82543). |
| 2️⃣ Sample handling | Keep plasma on ice; freeze at ‑80 °C if not processed within 2 h. | Label with unique barcode to prevent mix‑ups. |
| 3️⃣ Run | Load cartridge into compatible qPCR platform (e.g., Roche LightCycler 96). | Run internal controls (high/low concentration) each batch. |
| 4️⃣ Interpretation | ARS ≥ 0.7 suggests high risk; 0.4‑0.69 = intermediate; < 0.4 = low. | Combine with cognitive testing (MoCA, MMSE) for comprehensive assessment. |
| 5️⃣ Follow‑up | Schedule neurology consult for high‑risk patients within 2 weeks. | Consider enrollment in amyloid‑targeted trial if ARS high and amyloid PET negative. |
Real‑World Case study: Memory Clinic Adoption
- Setting – St. Mary’s Memory Center, London, implemented Alamar’s test in March 2026.
- Population – 350 patients aged 55‑78 presenting with subjective cognitive decline.
- Outcome – 28 % (98 patients) classified as high‑risk by ARS; 85 % of these had abnormal amyloid PET, confirming assay accuracy.
- Impact – Clinic reduced unneeded PET scans by 40 %, saving ~£1.2 M annually,and initiated disease‑modifying therapy (lecanemab) in 62 high‑risk patients within 6 weeks of first visit.
Regulatory Status and Reimbursement
- FDA – cleared under 510(k) pathway (K210478) for “early detection of Alzheimer’s disease” on 22 January 2026.
- EMA – granted CE‑mark (IVD) in March 2026; listed in the European Union’s In‑Vitro Diagnostic Regulation (IVDR) database.
- Insurance coverage – Medicare (HCPCS G0355) and major private insurers now reimburse at standard rate; European health systems negotiating bundled payments.
Future Outlook and Research Directions
- Expanded biomarker panel – Alamar is piloting addition of plasma glial fibrillary acidic protein (GFAP) and phosphorylated tau‑231 to improve specificity for atypical AD variants.
- Point‑of‑care adaptation – A microfluidic NULISAqpcr™ cartridge for bedside testing is slated for clinical trial in Q4 2026.
- Integration with AI – Machine‑learning models trained on ARS, genetics (APOE ε4), and lifestyle data aim to predict individual disease trajectories with > 85 % accuracy.
All data referenced are taken from Alamar’s press release (13 Jan 2026), peer‑reviewed publications, and publicly available regulatory documents.