# Biomarker Developmental Unit

> **NIH NIH U2C** · ARIZONA STATE UNIVERSITY-TEMPE CAMPUS · 2022 · $178,795

## Abstract

Abstract
 The Biomarker Reference Laboratory (BRL) core of the Arizona State University (ASU) Biomarker
Characterization Center (BCC) has two primary goals. The first is to adapt assays developed in the Biomarker
Discovery Laboratory (BDL) to the commercial assay platform from Meso Scale Diagnostics, LLC. (MSD) for
clinical validation. The second goal of the BRL is to participate in larger EDRN collaborative validation studies,
with support for optimization and verification of assays and improvement of diagnostic methods.
 This collaboration between ASU and MSD aims to identify and validate biomarkers related to lung cancer
and ovarian cancer. Serological markers represent a promising class of novel markers for early cancer detection.
These include autoantibodies [AAbs] against aberrant proteins from tumors, anti-glycosylated protein antibodies
(AGPA) against proteins aberrantly glycosylated in cancer, and anti-microbial antibodies against microbial
antigens that differ due to microbial differences between cancer and benign disease. Through replication of
antibody-producing B-cells, these antibodies amplify a signal from antigens at very low concentrations and at an
early stage in tumorigenesis when the corresponding antigens may not themselves be detectable in the
circulation.
 ASU’s Biodesign Institute developed a high-throughput immunoproteomics platform: Nucleic Acid-
Programmable Protein Array (NAPPA), which replaces the complex process of spotting purified proteins with the
simple process of spotting plasmid DNA followed by translation. This platform was used to identify promising
antibody candidates for both cancer types. MSD’s core expertise is development and validation of robust
multiplexed immunoassays (direct analyte detection and serology assays). The present proposal is directed
towards transferring established lung and ovarian cancer biomarkers and biomarkers discovered by the BCC
BDL onto the MSD platform. This platform is appropriate for large-scale validation testing and future clinical use.
Samples will be tested in MSD’s Bioanalytical Laboratory under Good Laboratory Practice (GLP) and at ASU.
 Up to ten biomarkers per year will be transferred to the BRL. The BDL will perform extensive clinical
validation to downselect markers for both types of cancer. Assays for the final set of approximately ten serology
and/or antigen detection assays will be validated to a level required for a Laboratory Developed Test (LDT) and
manufacturing procedures that would support the production of kits for ~10,000 samples will be developed.
 Additional collaborations of the BCC BRL with EDRN members may include development and/or scale-up
of critical reagents such as recombinant proteins or monoclonal antibodies, antibody affinity maturation, protein
assay development, extracellular vesicle detection, nucleic acid detection, multiplex panel development, assay
validation, and sample testing in MSD’s GLP laboratory.

## Key facts

- **NIH application ID:** 10487347
- **Project number:** 1U2CCA271903-01
- **Recipient organization:** ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
- **Principal Investigator:** Martin Stengelin
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $178,795
- **Award type:** 1
- **Project period:** 2022-09-01 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10487347

## Citation

> US National Institutes of Health, RePORTER application 10487347, Biomarker Developmental Unit (1U2CCA271903-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10487347. Licensed CC0.

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