NucleoBio, Corp., a leading biotechnology innovator in precision oncology diagnostics, and PreCheck Health Services, a high-complexity CLIA-certified and CAP-accredited clinical laboratory, today announced a strategic collaboration to support clinical development and processing of the proprietary Prostac™ assay. This partnership aims to enable future application of the test across a broader clinical setting, supporting ongoing research and validation efforts for early detection and risk stratification in prostate cancer.

The collaboration will leverage PreCheck’s advanced laboratory infrastructure and operational expertise to further validate and process Prostac™—a qPCR-based composite assay developed by NucleoBio to assess expression levels of specific long non-coding RNA biomarkers derived from the PVT1 gene.

Prostac™: A Novel Biomarker-Based Composite Score

At the core of this collaboration is Prostac™, a composite diagnostic score derived from the quantification of PVT1 exons 4A, 4B, and 9. These specific exons are significantly overexpressed in prostate cancer tissue in men of African ancestry and have demonstrated high accuracy in both preclinical and clinical models for distinguishing malignant from non-malignant samples.

Prostac™ integrates the measured expression levels using supervised machine learning techniques—specifically, support vector classifiers—to generate a score that accurately predicts the likelihood of prostate cancer. The assay has shown promising early results, with 100% sensitivity and specificity in preliminary in vitro evaluations using prostate epithelial and prostate cancer cell lines.

“Combining novel molecular markers with mathematical oncology through machine learning allows for robust and scalable diagnostic solutions,” stated Dr. Olorunseun Ogunwobi, co-developer of Prostac™ and co-founder of NucleoBio. “The ability to accurately identify early and aggressive cases of prostate cancer—non-invasively—represents a paradigm shift.”

“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,” says Neeti Mitra, Associate Director, CUNY Technology Commercialization Office, from where the core technology was licensed. “The vision of CUNY and NucleoBio was 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.”

Enabling Scalable, CLIA-Compliant Processing

PreCheck Health Services will serve as the exclusive laboratory processing facility for clinical samples analyzed using the Prostac™ assay during its validation phase. Leveraging PreCheck’s robust genetic testing platform and automation infrastructure, this collaboration ensures consistency, compliance, and scalability under CLIA and CAP regulations.

“As a clinical lab focused on precision medicine, we are proud to support a next-generation assay like Prostac™,” said Francis Pittilloni, Chief Operating Officer at PreCheck Health Services. “This initiative exemplifies our mission to bring forward validated, clinically actionable genetic tests that meet the highest standards of scientific and operational integrity.”

The assay will initially be utilized for research use only (RUO) and early validation studies. Both companies affirm their commitment to maintaining full compliance with FDA and CMS guidelines concerning laboratory-developed tests (LDTs), including appropriate use disclosures.

Addressing a Critical Clinical Gap

Prostate cancer remains the most diagnosed solid tumor among men globally, with significant racial disparities in incidence and mortality. While PSA testing remains the current standard, its limitations—high false-positive rates, lack of specificity, and poor predictive value—have underscored the need for new biomarkers. “This is improved medical care,” says Neeti Mitra, Associate Director CUNY TCO, “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.”

According to studies published in Frontiers in Oncology, PLOS ONE, and Genes, the PVT1 locus, particularly exon 9, plays a key oncogenic role in the initiation and progression of prostate cancer. Its upregulation correlates with castration resistance, increased cell proliferation, and poor prognosis.

The Prostac™ composite score is being developed to address this unmet need—offering clinicians a more precise and biologically relevant indicator of disease activity, with the potential to reduce unnecessary biopsies and enhance early intervention.

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.

Forward Outlook

Both parties plan to expand the clinical applications of the Prostac™ assay beyond the research phase, targeting broader clinical validation and potential inclusion in future clinical decision pathways. Further details regarding commercialization timelines and payer engagement will be announced following regulatory clearance and additional peer-reviewed studies.

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Early Prostate Cancer Detection: A Breakthrough Test NucleoBio and PreCheck Health Services partner to bring Prostac™, a highly accurate, non-invasive test to market, improving early detection and reducing disparities.