CEA Biomarker Detection Test

Introduction:

Carcinoembryonic antigen (CEA) is used as the primary biomarker for treatment response monitoring in colorectal cancer and as a secondary biomarker in breast and pancreatic cancer. India sees 70,000 new colorectal cancer cases every year, with a median survival rate of 90% at stage-1, and reducing to 50% at stage-3.

Technology:

• To measure CEA levels in serum extracted from blood.

• The device operates based on cyclic voltammetry, a widely used electrochemical technique. It measures the current response of an electrochemical cell as the potential is varied over time. The basic principle involves using a three-electrode system working, reference, and counter electrodes to detect the concentration of specific analytes based on their redox reactions. This methodology enables short-time analysis for the target analytes.

• The detector is an electrochemical biosensor, which measures a certain antigen based on the composition of the biosensor. Different composition leads to the detection of different antigens, for instance in one case, CEA-biomarker in blood serum, and in another case, oral cancer detection through saliva.

Current Stage: TRL 4 (in a lab environment using PBS Solution with CEA).

Sensitivity: LOD of 0.30 pg/mL (healthy – 1.55 ng/mL; colon cancer – 2.95 ng/mL).

Turn Around Time (TAT): 10 minutes (post serum extraction).

Use Case: For treatment response monitoring (test recommended every 3 months by Oncologists) to assess the effectiveness of the treatment and the likelihood of recovery or relapse after treatment.

USP: Rapid TAT and significantly lower operating cost than ELISA, CLIA, etc.

Target Partners: Antigen testing centers, device manufacturers, and NGOs.

Industry Partnership:

To make the device market-ready and bring it into commercial use.

Stage: 1 – Taking the device from TRL 4 to TRL 8 through industry-sponsored R&D.

Stage: 2 – Industry-sponsored clinical validation to validate the product viability.

Stage: 3 – Industry-sponsored manufacturing and market distribution/operations.

Commercials:

Industry expenditures in the first two stages will be credited towards the part-payment of the upfront licensing fee, with the balance due at the start of Stage 3, followed by lifetime royalty on sales.

Next Steps:

Contact bandhan@utopicplanet.org to initiate the NDA and arrange a meeting with the inventors and the team to materialize cost-effective CRC treatment monitoring.