# Genomic marker to distinguish aggressive and indolent prostate cancer

> **NIH NIH R43** · BIOMARKER CORPORATION · 2023 · $404,201

## Abstract

ABSTRACT
Prostate cancer is the most commonly diagnosed cancer in men, with an estimated 268,490 new cases in the
U.S. in 2022. At the time of a prostate cancer biopsy, pathologists use the tumor material to determine the grade
and stage. Primary treatment decisions are based on the biopsy tissue information and the PSA (prostate specific
antigen, blood test). About 80% of newly diagnosed cases are considered low-risk. Since in the majority of newly
diagnosed, low-risk prostate cancer cases the disease is indolent (~70%) and surgery comes with significant
adverse effects, a unique treatment option for many men with prostate cancer is Active Surveillance. There is
an urgent need for biomarkers that could supplement standard clinical variables (i.e., Gleason score, PSA, tumor
staging, number of positive biopsies, patient age) to predict tumors that will become aggressive cases that
require treatment and those that can safely elect Active Surveillance. The DNA copy number signature of the
tumor, called GEMCaP (Genomic Evaluators of Metastatic Cancer of the Prostate), was discovered by the
Principal Investigator. GEMCaP was validated in the post-surgery setting to identify those cases poised for
biochemical recurrence and metastasis. GEMCaP was recently evaluated in the Active Surveillance setting using
archived surgical tissue, adjacent to where the biopsy was sampled, in men with low-risk prostate cancer as
defined by clinical variables. GEMCaP independently predicted adverse pathology alongside a commercially
available RNA risk predictor. When combined with clinical variables, GEMCaP resulted in improved predictive
power of biochemical recurrence post-surgery compared to a commercial RNA assay. GEMCaP was also shown
to identify cases that can safely be managed with Active Surveillance, which has not previously been achieved
by commercially-available RNA competitor products. The goal of Biomarker Corporation’s NIH SBIR Phase I
project is to work toward commercializing GEMCaP using biopsy tissue and a custom sequencing panel. Biopsy
biospecimens for this study will be provided by the Canary Foundation’s well-annotated Active Surveillance
biospecimen collection of biopsy tissue with associated clinical variables and outcome data. The study will use
a commercial RNA biomarker assay as a comparator. The aims of this project are to 1) Determine if GEMCaP
can identify aggressive CaP in a cohort of patients considered clinically low-risk based on biopsies and compare
Biomarker Corp.’s proprietary algorithm in the Active Surveillance setting with the binary cut-off method, 2) Test
GEMCaP in identifying low-risk cases who can safely stay on Active Surveillance, 3) Compare GEMCaP’s
performance to a commercially available RNA predictor. In Phase II we will validate our findings in a larger cohort,
using the calling method identified in Aim 1. Successful clinical validation as a Phase II and implementation of
GEMCaP will improve prediction accuracy and thereby...

## Key facts

- **NIH application ID:** 10820859
- **Project number:** 1R43CA287601-01
- **Recipient organization:** BIOMARKER CORPORATION
- **Principal Investigator:** Randall Davis
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $404,201
- **Award type:** 1
- **Project period:** 2023-09-22 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10820859

## Citation

> US National Institutes of Health, RePORTER application 10820859, Genomic marker to distinguish aggressive and indolent prostate cancer (1R43CA287601-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10820859. Licensed CC0.

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