Biocerta Precision Diagnostics Announces Exclusive Licensing Agreement With the University of Miami and Strategic Development Partnership With Acumen Partners

Agreements Advance Biocerta’s Functional Precision Oncology Platform, Aiming to Deliver the Right Treatment, First Time, Every Time

PITTSBURGH--(BUSINESS WIRE)--Biocerta Precision Diagnostics, Inc., a biotechnology company pioneering functional drug sensitivity testing (DST) to personalize cancer therapy, today announced two major business milestones: (1) an exclusive licensing agreement with the University of Miami covering core intellectual property assets which contribute to Biocerta’s DST technology, and (2) a strategic development and commercialization agreement with Acumen Partners to support the Company through early stages of commercialization.

Together, these agreements align Biocerta’s scientific foundation and commercial execution to accelerate the availability of its CertaPath™ diagnostic platform, designed to guide oncologists toward the most effective and least toxic treatments for each individual patient.

“Every day, cancer patients endure toxic therapies that ultimately fail to help them. Too often, cancer drugs fail for any given patient, often discovered only after weeks of side effects and tens of thousands of dollars in wasted costs,” comments Kurt Weiss, MD, musculoskeletal oncologist at the University of Pittsburgh and UPMC Hillman Cancer Center, Biocerta’s Co-Founder and Medical and Scientific Advisory Board Chair. “For patients with rare or relapsed cancers, this trial-and-error approach typically means running out of time before finding an effective therapy.”

The core problem is that most cancer care still relies on population averages rather than individual biology. Genomic testing identifies actionable targets in only about 30% of cancers, leaving the majority of patients without clear guidance. Existing functional testing platforms are slow to yield results and are limited in scope, testing only a small number of compounds, while ignoring how normal tissue responds to treatment.

Biocerta’s platform directly addresses these limitations. Using fresh tumor tissue, the company’s functional drug sensitivity test screens more than 200 FDA-approved compounds in just 14 days, simultaneously measuring cancer cell death and normal tissue toxicity. This dual assessment, unique to Biocerta, provides clinicians with actionable, personalized insights into which drugs are most likely to work for each patient, while minimizing harmful side effects.

The University of Miami has granted Biocerta an exclusive license to intellectual property covering ex vivo drug sensitivity testing technology developed by a team of researchers that included Biocerta’s Chief Scientific Officer, Dr. Lohse, as co-inventor.

Under the terms of the agreement, the University of Miami received an equity position in the Company. Biocerta was represented on the transaction by its IP counsel, ArentFox Schiff LLP, and corporate counsel, Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP.

“This agreement builds on years of scientific collaboration and validates the clinical importance of functional precision diagnostics,” said Ines Lohse, PhD, Chief Scientific Officer of Biocerta Precision Diagnostics. “Building on the technology licensed from the University of Miami, we can accelerate translation of this technology from the laboratory into clinical use, where it can make a tangible difference for patients.”

Preceding the University of Miami licensing agreement, Biocerta entered into a comprehensive development and commercialization agreement with Acumen Partners, a healthcare investment and advisory firm. Acumen principals will assume an active, collaborative role in the Company and on the Board of Directors.

“Biocerta, its CertaPath™ DST, and the collaboration with Acumen Partners represent a powerful alignment between scientific excellence and commercial execution,” said Doug McCormack, CEO of Acumen Partners. “Biocerta offers cancer patients and oncologists game-changing technology, the potential for game-changing improvements in patients' outcomes, and we are committed to supporting its efforts to realize its potential.” McCormack will serve as Biocerta’s Chairman.

Biocerta’s initial focus is to advance functional drug sensitivity testing across cancers where treatment decisions are most uncertain, beginning with rare and aggressive tumors, where unmet needs are high and the regulatory approval process may be accelerated. The insights and regulatory groundwork from these early applications form the foundation for expanding into more common types of cancer.

Biocerta’s platform has already demonstrated promising results in early clinical validation. In pediatric sarcoma, we observed treatment suggestions lying outside of standard treatment, highlighting the need for individual solutions with one patient achieving over 90% tumor necrosis following Biocerta’s recommendations. In relapsed leukemia patients where standard treatments achieved no responses, 60% of patients responded to therapy guided by Biocerta’s DST.

By reducing ineffective treatments and associated toxicity, Biocerta’s approach aligns with payer and health-system incentives to improve outcomes while lowering costs.

“Our mission is simple but urgent—ensure that every patient receives the right treatment, first time, every time,” said Dr. Lohse. “These agreements provide the scientific and commercial foundation to make that vision a clinical reality.”

About Biocerta Precision Diagnostics: Based in Pittsburgh, PA, Biocerta Precision Diagnostics is a functional precision oncology company transforming cancer care from trial-and-error to individualized therapy selection. Its ex vivo drug sensitivity testing platform evaluates fresh tumor tissue against more than 200 FDA-approved compounds within 14 days, uniquely comparing cancer and normal tissue responses to identify therapies that maximize efficacy while minimizing toxicity. Biocerta’s mission: Right treatment, first time, every time.

About the University of Miami: The University of Miami is one of America's top research universities located in one of the most dynamic and multicultural cities in the world. With more than $456 million in research and sponsored program expenditures annually, the University of Miami is a member of the prestigious Association of American Universities (AAU). Only 3 percent of four-year institutions in the nation are invited to join the AAU, which recognizes breadth and quality of research and scholarship. While the majority of this work is housed at the Miller School of Medicine, investigators conduct hundreds of studies in other areas, including marine science, engineering, education, and psychology.

About Acumen Partners: Acumen Partners is a Washington, D.C., healthcare investment and advisory firm specializing in active engagement with technical founders and innovative, early-stage companies to realize vision through driven execution.

Forward-Looking Statements: Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially. Such statements include expectations regarding commercialization, clinical performance, and strategic milestones. Biocerta disclaims any obligation to update or revise these statements except as required by law.