DEERFIELD BEACH, Fla., June 25, 2026 (GLOBE NEWSWIRE) -- OTraces, Inc., a diagnostics company developing proteomic blood tests for early cancer detection, announced today that the Florida Department of Health has awarded the company a $2 million, 12-month grant under the Florida Cancer Innovation Fund. The grant will support a prospective, multi center clinical study titled “High Accuracy Early Detection of Prostate Cancer Using the OTraces Proteomic Diagnostic Platform” designed to improve decision making for prostate biopsies in men with elevated prostate specific antigen (PSA) levels.
Grant Program and Study Overview
The award is funded through the Florida Biomedical Research Programs’ Florida Cancer Innovation Fund, which supports peer‑reviewed, competitive research aimed at accelerating progress toward cancer cures and improving care for Floridians. Under Contract 26C07, the grant term runs from April 1, 2026 through March 31, 2027, with a fixed‑price, fixed‑fee structure tied to defined research and reporting deliverables.
The OTraces project will conduct a prospective, multi‑center, blinded diagnostic accuracy study enrolling approximately 954 men with elevated PSA who are scheduled for a prostate biopsy as part of standard clinical care. Each participant will receive an OTraces blood test and a standard‑of‑care prostate biopsy, allowing direct comparison of test performance against biopsy histology, the current reference standard.
Clinical Need and Innovation
In the United States, approximately 1,000,000 prostate biopsies are performed annually, most often triggered by an abnormal PSA result. More than 70% of these biopsies are benign, meaning no cancer is found, despite the procedure’s cost, invasiveness, and associated risks such as pain, bleeding, and infection.
The OTraces blood test analyzes a panel of serum protein biomarkers, including IL‑6, IL‑8, TNF‑α, VEGF, and PSA, using a proprietary algorithm to determine the likelihood of clinically significant prostate cancer. By being designed to offer higher specificity than PSA alone, the test is intended to help clinicians more accurately identify which men may need a biopsy and which may be able to avoid the procedure. These potential benefits are being evaluated in the funded study.
Study Objectives and Design
The primary objective of the study is to evaluate whether the OTraces test is superior to standard PSA testing in predicting prostate biopsy outcomes in men with PSA levels of at least 3 ng/mL. Secondary objectives include differentiating aggressive from indolent prostate cancer and exploring the relationship between individual biomarkers and biopsy results.
The study will be conducted as a minimal‑risk, prospective, blinded study in Florida, with all research activities carried out at Florida sites in accordance with Good Clinical Practice. De‑identified serum samples will be processed at participating centers, shipped to a central laboratory for biomarker analysis, and then interpreted via the OTraces Laboratory Information Management System using the company’s proprietary algorithm.
Potential Impact for Florida Patients and Health System
Prostate biopsies in Florida typically cost between $4,864 and $5,334 per procedure, representing a significant burden when a majority of procedures yield benign findings. If the study’s objectives are met, more accurate biopsy referral decisions could potentially help to:
- Reduce the number of unnecessary biopsies and related complications for Florida men with elevated PSA.
- Lower overall prostate cancer diagnostic costs for the state’s health system and payers.
- Enable earlier and more targeted detection of clinically significant prostate cancer cases that require timely intervention.
“Being selected by the Florida Department of Health’s Florida Cancer Innovation Fund is a major milestone for OTraces and for men’s health in Florida,” said Alain D. Cappeluti, Co-Founder and President, OTraces, Inc. “This grant allows us to clinically validate our proteomic platform in a real‑world setting and demonstrate its ability to safely reduce the number of men undergoing unnecessary prostate biopsy.”
“Florida has made a strong commitment to supporting innovative, translational cancer research,” said Mr. Cappeluti. “By rigorously comparing the OTraces test against biopsy outcomes in nearly one thousand patients, this project is designed to generate the evidence needed to bring more precise, less invasive diagnostic options to Floridians.”
About the OTraces Proteomic Diagnostic Platform
The OTraces platform combines multiplexed measurement of serum inflammatory and angiogenic biomarkers with PSA, applying proprietary machine‑learning algorithms to generate a quantitative assessment of cancer risk from a standard blood draw. The technology is designed to be adaptable across multiple solid tumor types, with prostate cancer representing a key initial indication due to the unmet need around PSA‑driven biopsy decisions.
About OTraces, Inc.
OTraces, Inc. is a diagnostics company focused on developing and commercializing blood‑based proteomic tests for early cancer detection and treatment guidance. By leveraging advanced biomarker panels and proprietary algorithms, OTraces aims to improve diagnostic accuracy, reduce unnecessary invasive procedures, and lower the overall cost of cancer care.
Company Contact:
Alain D. Cappeluti
Co-Founder, and President & CFO
OTraces, Inc.
acappeluti@otraces.com
Media Contact:
Sasha Whitaker
Public Relations, Whitworks
Email: sasha@whitworks.io
