Enzyme-Linked DNA Displacement (ELIDIS) Assay as an innovative immunoassay platform

Introduction

Since its introduction more than 50 years ago, ELISA (Enzyme-Linked Immunosorbent Assay) remains one of the most widely used technologies for research, drug discovery, and diagnosis. The reasons for this extraordinary longevity are manifold: ELISA combines the high specificity of antibody-antigen interactions with the high sensitivity of enzyme amplification.

Limitations of ELISA

However, ELISA also has disadvantages:

• Multiple washing steps and reagents are required.
• A specialized instrument is needed, which is not always available in all laboratories.

An innovative immunoassay technology that can overcome the limitations of ELISA while retaining all of its best features would therefore represent a turning point in the global immunoassay market (> $35 billion in 2023).

Development of ELIDIS

Under the ERC Consolidator Grant PRO-TOOLKITS, we have developed a novel immunoassay, which we have named Enzyme-Linked DNA Displacement (ELIDIS). This technology has all the characteristics to meet this need and become an alternative to ELISA.

In short, ELIDIS involves two steps and is based on the use of enzyme-conjugated DNA strands and disposable electrodes. ELIDIS retains the advantageous properties of ELISA (high sensitivity and specificity) but, unlike ELISA, is easier to perform, does not require enzyme-labeled antibodies, and, more importantly, can be performed using portable electronic devices such as a laptop or smartphone without the need for additional instruments.

Project Goals

With these considerations in mind, in this PoC project we will validate the ELIDIS assay as a candidate to replace ELISA in any biotech and biopharma laboratory. To achieve the above goal, we will:

1. Validate the ELIDIS assay for the detection of two model targets (Trastuzumab and EGFR).
2. Develop two prototype kits using disposable sensor arrays and a portable device (or an app/software).
3. Create a “manufacturing plan” for assay production.
4. Develop an IP strategy for patent filing/maintenance.
5. Create a plan for business/commercialization.