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Seed Amplification Immunoassay (SAIA) for Synucleinopathies

Abstract

QABY's Seed Amplification Immunoassay (SAIA) represents a groundbreaking advancement in the diagnosis of synucleinopathies such as Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). This cutting-edge assay leverages the detection of alpha-synuclein (α-syn) aggregates, a key biomarker of these neurodegenerative disorders, offering unparalleled sensitivity and specificity.

Key Performance Indicators

91.5%

Sensitivity

90.2%

Specificity

0.96

AUC

Conclusion

The SAIA assay represents a significant advancement in the diagnosis of synucleinopathies. Its key advantages include:

  • High sensitivity and specificity for α-syn aggregates
  • Ability to detect trace amounts of aggregates, enabling early diagnosis
  • Clear differentiation between synucleinopathies and other neurodegenerative disorders
  • Potential for monitoring disease progression and treatment efficacy in clinical trials

These features position SAIA as a powerful tool in the fight against neurodegenerative diseases, offering new hope for early intervention and improved patient outcomes.

Our Development Pipeline

Plasma-Based SAIA Assay Development

Current Stage

Adaptation and validation of the Seed Amplification Immunoassay (SAIA) for use in plasma samples.

Next Steps

  • Complete optimization of plasma-based assay sensitivity and specificity.
  • Conduct validation studies in patient cohorts to ensure clinical utility.
  • Collaborate with healthcare providers for regulatory approval and implementation in diagnostic laboratories and contract research organisations.

Goal

Launch the plasma-based SAIA assay as a non-invasive, accessible diagnostic tool for early detection and differentiation of synucleinopathies.

Immuno-PET Imaging Nanobody Development

Current Stage

Nanobodies have been successfully developed and validated in vivo in animal model to bind intracellular alpha-synuclein (α-syn) aggregates with high specificity.

Next Steps

  • Conjugate the developed nanobodies with appropriate radioisotopes for PET imaging.
  • Conduct preclinical imaging studies in animal models to evaluate biodistribution, target specificity, and imaging sensitivity.
  • Validate the nanobody-based immuno-PET imaging tool in patients with Parkinson's disease and other synucleinopathies.

Goal

Launch a non-invasive diagnostic platform for early detection, disease progression monitoring, and therapeutic evaluation.

Preclinical Development of Nanobody Therapeutics

Current Stage

Preclinical studies of nanobody therapies targeting alpha-synuclein aggregates are ongoing using animal models.

Next Steps

  • Finalize preclinical efficacy and safety testing in animal models.
  • Optimize nanobody formulation for maximum intracellular delivery and stability.

Goal

Transition to Phase 1 clinical trials, focusing on disease-modifying therapies for Parkinson's disease and other synucleinopathies.

Contact Us

We're excited to hear from you and discuss how QABY can revolutionize neurodegenerative disease care.