OTraces Awarded $2 Million Florida Grant to Validate Proteomic Blood Test for Reducing Unnecessary Prostate Biopsies
核心洞察
OTraces, Inc. (搜索) received a $2 million, 12-month grant from the Florida Department of Health's Florida Cancer Innovation Fund to support a prospective, multi-center clinical study.
The study will enroll approximately 954 men with elevated PSA (搜索) levels scheduled for prostate biopsy, directly comparing the OTraces proteomic blood test against biopsy histology.
The OTraces test analyzes a panel of biomarkers including IL-6, IL-8 (搜索), TNF-α (搜索), VEGF (搜索), and PSA (搜索) using proprietary algorithms to improve specificity over PSA testing alone.
DEERFIELD BEACH, Fla. — OTraces, Inc. (搜索), a diagnostics company focused on proteomic blood tests for early cancer detection, announced on June 25, 2026 that the Florida Department of Health has awarded the company a $2 million, 12-month grant under the Florida Cancer Innovation Fund. The funding will support a prospective, multi-center clinical study designed to validate the company's non-invasive proteomic diagnostic platform for improving prostate biopsy decision-making in men with elevated prostate-specific antigen (PSA (搜索)) levels.
The grant, issued under Contract 26C07 through the Florida Biomedical Research Programs, runs from April 1, 2026 through March 31, 2027, with a fixed-price, fixed-fee structure tied to defined research and reporting deliverables.
The Clinical Need: Addressing PSA (搜索)'s Limitations
In the United States, approximately 1,000,000 prostate biopsies are performed annually, most often triggered by an abnormal PSA (搜索) result. Yet more than 70% of these biopsies return benign findings — meaning no cancer is found — despite the procedure's cost, invasiveness, and associated risks including pain, bleeding, and infection.
In Florida specifically, prostate biopsies typically cost between $4,864 and $5,334 per procedure, representing a significant financial burden when the majority yield benign results.
The OTraces Proteomic Platform
The OTraces blood test analyzes a panel of serum protein biomarkers — including IL-6, IL-8 (搜索), TNF-α (搜索), VEGF (搜索), and PSA (搜索) — using a proprietary machine-learning algorithm to generate a quantitative assessment of cancer risk from a standard blood draw. By being designed to offer higher specificity than PSA alone, the test aims to help clinicians more accurately identify which men may need a biopsy and which may be able to safely avoid the procedure.
The platform combines multiplexed measurement of serum inflammatory and angiogenic biomarkers with PSA (搜索), and the technology is designed to be adaptable across multiple solid tumor types. Prostate cancer (搜索) represents a key initial indication due to the well-documented unmet need surrounding PSA-driven biopsy decisions.
Study Design and Objectives
The study, titled "High Accuracy Early Detection of Prostate Cancer (搜索) Using the OTraces Proteomic Diagnostic Platform," will enroll approximately 954 men with elevated PSA (搜索) levels (at least 3 ng/mL) who are scheduled for a prostate biopsy as part of standard clinical care. Each participant will receive both an OTraces blood test and a standard-of-care prostate biopsy, enabling direct comparison of test performance against biopsy histology — the current reference standard.
The primary objective is to evaluate whether the OTraces test is superior to standard PSA (搜索) testing in predicting prostate biopsy outcomes. Secondary objectives include differentiating aggressive from indolent prostate cancer (搜索) and exploring the relationship between individual biomarkers and biopsy results.
The study will be conducted as a minimal-risk, prospective, blinded study, 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 interpreted via the OTraces Laboratory Information Management System using the company's proprietary algorithm.
Potential Impact
If the study's objectives are met, more accurate biopsy referral decisions could reduce the number of unnecessary biopsies and related complications for men with elevated PSA (搜索), lower overall prostate cancer (搜索) diagnostic costs for the state's health system and payers, and enable earlier and more targeted detection of clinically significant prostate cancer cases requiring 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 of OTraces, Inc. (搜索) "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," Cappeluti added. "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."