NucleoBio, Corp., a biotechnology innovator in precision oncology diagnostics, has announced a new strategic collaboration with PreCheck Health Services, a high-complexity CLIA-certified and CAP-accredited clinical laboratory. The partnership will support the clinical development and processing of Prostac™, NucleoBio’s proprietary diagnostic assay for prostate cancer.
This collaboration represents a significant step toward bringing Prostac™ into broader clinical application. By combining NucleoBio’s expertise in biomarker discovery and assay development with PreCheck’s advanced laboratory infrastructure, the initiative will focus on validating the assay in real-world settings, supporting early detection, risk stratification, and potentially revolutionizing the way prostate cancer is diagnosed and managed.
Prostac™: A Next-Generation Diagnostic Solution
At the heart of the collaboration is Prostac™, a composite biomarker-based assay designed to improve the accuracy of prostate cancer testing. Unlike conventional diagnostic tools, which rely heavily on prostate-specific antigen (PSA) testing, Prostac™ uses a more advanced molecular approach.
The test quantifies expression levels of long non-coding RNA (lncRNA) biomarkers derived from the PVT1 gene, specifically exons 4A, 4B, and 9. These exons are significantly overexpressed in prostate cancer tissue, particularly in men of African ancestry, who are disproportionately affected by the disease.
By integrating these expression data points into a composite score using supervised machine learning—most notably support vector classifiers—Prostac™ can generate an accurate prediction of cancer likelihood. Early laboratory studies have demonstrated 100% sensitivity and specificity in distinguishing malignant from non-malignant samples across prostate epithelial and prostate cancer cell lines.
Dr. Olorunseun Ogunwobi, co-developer of Prostac™ and co-founder of NucleoBio, emphasized the novelty of the approach:
“Combining novel molecular markers with mathematical oncology through machine learning allows for robust and scalable diagnostic solutions. The ability to accurately identify early and aggressive cases of prostate cancer—non-invasively—represents a paradigm shift.”
From Discovery to Translation: Technology Transfer Success
The foundation of Prostac™ traces back to research conducted within the City University of New York (CUNY) system. The CUNY Technology Commercialization Office (TCO) played a pivotal role in licensing the core intellectual property to NucleoBio for development and commercialization.
Neeti Mitra, Associate Director at CUNY TCO, noted the alignment of vision between the university and NucleoBio:
“The process of moving scientific findings or innovations from research institutions into the commercial sector and generating social impact is the main goal of any tech transfer. The vision of CUNY and NucleoBio was the same from the beginning: to turn cutting-edge research into market-ready products. Hence, we are excited about this collaboration between NucleoBio and PreCheck Health Services.”
This collaboration highlights the importance of partnerships between academia, biotechnology startups, and clinical laboratories in translating early discoveries into solutions with the potential for global healthcare impact.
PreCheck’s Role: Enabling Scalable, CLIA-Compliant Processing
As part of the agreement, PreCheck Health Services will become the exclusive laboratory partner for processing Prostac™ clinical samples during its validation phase. The lab will leverage its established automation infrastructure, genetic testing expertise, and quality assurance systems to ensure scalability and regulatory compliance.
By conducting all processing under CLIA and CAP standards, the collaboration ensures that Prostac™ will meet the rigorous requirements needed for clinical use. This foundation is critical as the assay progresses from research use only (RUO) toward potential submission as a laboratory-developed test (LDT) and eventual broader adoption.
Francis Pittilloni, Chief Operating Officer of PreCheck Health Services, emphasized the lab’s commitment to innovation:
“As a clinical lab focused on precision medicine, we are proud to support a next-generation assay like Prostac™. This initiative exemplifies our mission to bring forward validated, clinically actionable genetic tests that meet the highest standards of scientific and operational integrity.”
Addressing a Critical Gap in Prostate Cancer Care
Prostate cancer is the most diagnosed solid tumor in men worldwide, affecting millions each year. According to the World Health Organization, it accounts for more than 1.4 million new cases annually. Despite its prevalence, current diagnostic methods are far from perfect.
PSA testing, the standard tool used for decades, is plagued by high false-positive rates, lack of specificity, and poor predictive value. Elevated PSA levels can often be caused by benign conditions such as prostatitis or benign prostatic hyperplasia (BPH), leading to unnecessary biopsies and patient anxiety. Conversely, aggressive cancers can sometimes develop in men with only modest PSA elevations, leaving clinicians uncertain about treatment strategies.
These limitations disproportionately impact men of African ancestry, who face significantly higher incidence and mortality rates. Genetic differences, including PVT1 exon overexpression, may contribute to these disparities.
Prostac™ directly addresses these challenges by focusing on biologically relevant markers of disease progression. By offering a molecularly precise assessment of cancer likelihood, it could reduce reliance on invasive biopsies, improve patient stratification, and guide earlier intervention for aggressive disease.
As Mitra of CUNY noted:
“This is improved medical care—transferring medical technologies like this with the future goal of bringing good quality healthcare to remote areas, reducing mortality, and improving well-being. It will revolutionize treatment, making healthcare more personalized and accessible.”
Scientific Foundations: The Role of PVT1
The scientific basis for Prostac™ is supported by numerous peer-reviewed studies, including research published in Frontiers in Oncology, PLOS ONE, and Genes. These studies confirm that the PVT1 locus—particularly exon 9—plays a critical oncogenic role in prostate cancer initiation and progression.
- Upregulation of PVT1 is associated with castration resistance, increased cell proliferation, and poorer clinical outcomes.
- Its activity correlates with aggressive disease features, making it a powerful biomarker for both detection and prognosis.
- In men of African ancestry, the overexpression of PVT1 exons is even more pronounced, making it especially relevant for addressing racial disparities in outcomes.
By quantifying these exons and incorporating them into a machine-learning model, Prostac™ has the potential to provide a clinically actionable score that reflects real tumor biology.
Looking Ahead: From Validation to Clinical Adoption
Initially, Prostac™ will be deployed under research use only (RUO) conditions as NucleoBio and PreCheck conduct larger validation studies. The goal is to establish clinical utility across diverse patient populations and demonstrate scalability for routine use.
Both organizations reaffirm their commitment to compliance with FDA and CMS guidelines governing laboratory-developed tests (LDTs), ensuring that all results are interpreted within appropriate regulatory frameworks.
Once validated, the test could become a valuable tool for:
- Early detection of prostate cancer in at-risk populations.
- Risk stratification, distinguishing indolent from aggressive disease.
- Reducing unnecessary biopsies, thereby lowering costs and patient burden.
- Guiding personalized treatment decisions in precision oncology settings.
A Vision for the Future
The collaboration between NucleoBio and PreCheck Health Services underscores the importance of partnerships in advancing cancer diagnostics. By bridging academic research, biotech innovation, and clinical laboratory excellence, the alliance sets the stage for delivering more precise, accessible, and equitable cancer testing.
If Prostac™ continues to demonstrate high accuracy and reproducibility, it could mark a turning point in prostate cancer care, particularly for populations that have historically faced worse outcomes.
As Dr. Ogunwobi summarized:
“The ability to accurately identify prostate cancer non-invasively, and to do so in a way that accounts for biological differences across populations, is a major step forward. This collaboration brings us closer to making that vision a reality.”
About NucleoBio, Corp.
NucleoBio is a translational biotechnology company that spun out of Hunter College of The City University of New York (CUNY). Focused on addressing cancer health, NucleoBio develops RNA-based assays and molecular diagnostics derived from peer-reviewed research, including pioneering work on the PVT1 gene and its application in prostate cancer. NucleoBio’s core technologies are built on the foundation of validated molecular biology and machine learning models that support precision oncology.
About PreCheck Health Services
PreCheck Health Services is a CAP-accredited, CLIA-certified high-complexity laboratory specializing in advanced molecular testing for oncology, pharmacogenetics, and neurogenetics. Serving providers nationwide, PreCheck combines rigorous scientific standards with cutting-edge automation, offering scalable, compliant, and clinically relevant diagnostic services that support personalized care and medical innovation.
About CUNY
The City University of New York is the nation’s largest urban public university, a transformative engine of social mobility that is a critical component of the lifeblood of New York City. Founded in 1847 as the nation’s first free public institution of higher education, CUNY today has 26 colleges spread across New York City’s five boroughs, serving nearly 240,000 degree-seeking students of all ages and awarding 50,000 degrees each year.
More than 80 percent of the University’s graduates stay in New York, contributing to all aspects of the city’s economic, civic and cultural life and diversifying the city’s workforce in every sector. The University’s historic mission continues to this day: provide a public first-rate education to all students, regardless of means or background.
