Early detection of cancer is amongst the most important problems to address in biomedical research because the earlier cancer is detected, the better chance of a cure or a successful treatment. In contrast to the current approach of DNA liquid biopsy, we propose to develop an ultra-sensitive immunoassay technology that enables protein liquid biopsy for early cancer detection. By leveraging our insights in improving signal-to-background ratio, we have developed a prototype immunoassay named NULISA, or NUcleic acid-Linked Immuno- Sandwich Assay, that has achieved unprecedented level of detection sensitivity of any commercially available immunoassays at ~20,000 molecules/mL (i.e. ~30 aM). In this proposal, we aim to optimize the NULISA assay to further boost lower limit of detection and limit of quantitation (LOD and LOQ) and test a few candidate markers for their potential in early cancer detection.
The specific aims of this Phase 1 SBIR proposal include: 1) Optimize single plex NULISA for ultrasensitive detection of protein markers in plasma and demonstrate minimally 10- fold better detection sensitivity over the most sensitive immunoassay on market; and 2) Demonstrate initial proof of concept of NULISA for early cancer detection. At the end of this project, we expect to have established a high performance NULISA assay and the feasibility of novel markers for early cancer detection. The longer-term goal of the project is to develop noninvasive single- and/or pan-cancer screen tests that could detect cancer much earlier for more successful or curative treatment.

Public Health Relevance

This project aims to develop a novel ultra-sensitive immunoassay technology that enables protein liquid biopsy and demonstrates feasibility for early cancer detection. The longer-term goal of the project is to develop noninvasive single- and/or pan-cancer screen tests that could detect cancer much earlier for more successful or curative treatment.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43CA254548-01
Application #
10080139
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Pond, Monique Adrianne
Project Start
2020-07-01
Project End
2021-06-30
Budget Start
2020-07-01
Budget End
2021-06-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Alamar Biosciences, Inc.
Department
Type
DUNS #
056507139
City
Hayward
State
CA
Country
United States
Zip Code
94545