Inanovate's biomarker screening system, the i-Assay™, is a proprietary reverse capture assay procedure for the rapid and accurate screening of auto-antibody biomarkers. The i-Assay™ is a unique method of biomarker discovery. It differs from standard biomarker profiling methods by asking the question: ‘What does the immune system see?’ This is a critical and powerful distinction which provides powerful benefits to researchers profiling protein based biomarkers. Some key features of the i-Assay™ include:

• It's based upon profiling robust auto-antibodies as opposed to more fragile antigens.
• It's based on native antigen recognition resulting in higher disease correlation - a key and powerful differentiator to alternative reverse capture approaches.
• It's based on the simultaneous and multiplexed recognition of many antigens, as opposed to a single or small set of antigens used with other protein based disease detection systems.
• It's based on a positional micro-array approach enabling both the discovery and validation processes.

Limitations of current biomarker screening systems

Existing techniques are limited in their capacity to screen effectively for biomarkers. Indeed, at present most biomarkers used in clinical practice do not reach the required levels for sensitivity and specificity. Furthermore, there are several conditions for which few or no biomarkers exist. Specific problems include:

• Complexity of the system and very strong matrix affect: With splice variants and post translational modifications there maybe be over 300,000 different proteins in the human plasma serum proteome.
• High patient variability: Differences in read outs of samples taken from the same patient at different times on the same day, driven by environmental influences and diet.
• Low stability: Many antigens are rapidly cleared form the body, transiently expressed and/or subjected to proteolysis.
• Low sensitivity: Antigen biomarker abundance can be too low for early stage detection.
• Low disease specificity: Typical antigen biomarkers are not exclusively expressed as a result of disease, but present in a variety of biological processes.

Furthermore, existing reverse capture screening systems rely on recombinant antigens as capture probes. Unfortunately, a critical flaw in this technique is that it can lead to antibody biomarkers that have low correlations across patient populations. By introducing the 'native antigen' as a capture probe, biomarker correlations across patient populations have been shown to increase from 0.2 to over 0.9, directly addressing this issue from existing reverse capture systems.

Benefits of the i-Assay

The i-Assay™ provides the following key benefits to researchers working in biomarker discovery and / or validation:

• Lowers the complexity of the matrix: Because antibodies, not protein antigens, are being screened, serum matrix effects can be eliminated through a simple separation step and introduction of a uniform sample buffer.
• Provides higher reproducibility and lower patient variability: Auto-antibodies are more stable than the antigens with no matrix affect, and are not as succeptable to environmental or dietary effects.
• Provides higher sensitivity and disease specificity: The immune system response effectively amplifies the presence of low abundance proteins.
• Higher disease correlation: Recognizes antigens with post translational modifications.

In addition to working directly with biomarker researchers wishing to benefit from the i-Assay™, Inanovate continues to seek collaborations and strategic alliances to help deliver the i-Assay™ to end users within pre-clinical research based markets. The offering includes:

• A license to market and sell assay kits based on the patented reverse capture process.
• Access to expertise, facilities and biomarker content to support the development and validation of the new assay kits.