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Analytical Suitability and Storage-Stability Pilot for a Serum NMR-Based Multi-Omics Multi-Cancer Early Detection Assay Using Pre-Diagnostic PLCO Specimens

Principal Investigator

Name
PATRICK STRASSER

Degrees
M.Sc.

Institution
Wholomics GmbH

Position Title
CEO

Email
strasserp@wholomics.com

About this CDAS Project

Study
PLCO (Learn more about this study)

Project ID
2026-0185

Initial CDAS Request Approval
Sep 15, 2026

Title
Analytical Suitability and Storage-Stability Pilot for a Serum NMR-Based Multi-Omics Multi-Cancer Early Detection Assay Using Pre-Diagnostic PLCO Specimens

Summary
Most cancers are detected at advanced stages, when curative treatment options are limited. While screening has reduced mortality for a small number of cancers, no validated tool exists for population-scale early detection across multiple cancer types. Blood-based multi-cancer early detection (MCED) assays offer a promising route, but current approaches face limitations in early-stage sensitivity, specimen volume requirements, and cost.

This project evaluates the analytical suitability of pre-diagnostic PLCO serum specimens for a serum-based nuclear magnetic resonance (NMR) multi-omics MCED assay that interrogates proprietary metabolomic, lipidomic, and proteomic molecular signatures from a single low-volume serum sample. The assay has demonstrated 95.0% Stage I sensitivity at 99.0% specificity (AUC 0.991) across ten solid-tumor types in independent blinded validation using a locked machine-learning pipeline. Before requesting irreplaceable PLCO specimens for a full retrospective validation study, the suitability of long-term archived PLCO serum for this assay must be established.

We propose a small analytical pilot using 100 PLCO serum specimens: 50 incident solid-tumor cases (lung, colorectal, ovarian, bladder) and 50 matched cancer-free controls, split equally between specimens stored at −70 °C (T0–T2) and −157 °C (T4/T5). The primary objectives are to assess (1) analytical quality and signal recovery of archived PLCO serum on the NMR platform, and (2) the effect of differing long-term storage conditions on assay readouts.

Analyses will characterize spectral quality, signal recovery, and analyte stability, comparing the two storage strata. Successful demonstration of analytical suitability and storage robustness will provide the foundation for a subsequent full retrospective case–control validation study — including formal assay reproducibility assessment — to be submitted as a separate EEMS application. This pilot directly addresses the NCI strategic priority of improving early cancer detection.

Aims

Aim 1 — Analytical quality and signal recovery. Determine whether long-term archived PLCO serum yields spectral quality and signal recovery sufficient for the serum NMR multi-omics MCED assay, characterizing any evidence of analyte degradation associated with archival storage.

Aim 2 — Effect of storage conditions. Compare assay readouts between specimens stored at −70 °C (T0–T2) and −157 °C (T4/T5), using a balanced 25/25 case/control allocation per storage stratum, to assess the impact of storage temperature and archival duration on assay performance.

Exploratory. Assess preliminary concordance of assay-derived molecular signatures with known case/control status, to inform the design, powering, and reproducibility planning of a subsequent full retrospective validation study.