Predictive Oncology Announces Planned European Launch of its ChemoFx® Treatment Selection Marker and Tumor Profiling Assay

Rhea-AI Summary

Predictive Oncology (NASDAQ: POAI) has announced plans to launch its ChemoFx® drug response assay in Europe and expand its availability in the United States. The assay, initially focusing on gynecological cancers, tests individual cancer patients' tumor responses to various chemotherapies before treatment selection.

The company's biobank contains approximately 150,000 live cell tumor samples, with nearly half being gynecological cancers. The platform has been validated against 175 FDA-approved drugs and 130 primary ovarian tumor samples. The market opportunity is significant, with about 115,000 new gynecological cancer cases annually in the US and 250,000 in Europe.

According to CEO Raymond Vennare, when previously introduced to the market, ChemoFx® generated gross revenues exceeding $25 million annually. The technology serves dual purposes: personalized cancer treatment and development of AI-driven clinical decision support tools in oncology.

Positive

• Previous ChemoFx® revenue generation exceeded $25M annually
• Large market opportunity with 365,000 combined annual gynecological cancer cases in US and Europe
• Extensive biobank of 150,000 live cell tumor samples
• Platform validated against 175 FDA-approved drugs

Negative

• None.

Insights

Medical Research Analyst

The planned European launch of ChemoFx® represents a strategic expansion into a substantial market with 250,000 annual gynecologic cancer cases. The assay's ability to test tumor responses to multiple chemotherapies before treatment provides important personalization capabilities that could significantly improve patient outcomes. The historical revenue generation of $25 million annually demonstrates proven commercial viability.

The biobank's extensive collection of 150,000 live cell tumor samples, with approximately 75,000 gynecological cancer specimens, provides a robust foundation for AI-driven drug discovery and personalized medicine. The validation against 175 FDA-approved drugs and 130 primary ovarian tumor samples establishes strong clinical credibility.

Financial Analyst

This expansion represents a significant revenue opportunity for POAI, particularly given the historical precedent of $25 million annual gross revenue from ChemoFx®. The European market, with more than double the gynecologic cancer cases compared to the US (250,000 vs 115,000), presents substantial growth potential. The dual revenue streams from clinical testing services and AI-driven drug discovery create multiple paths to monetization.

For a company with a market cap of just $8.2 million, successfully penetrating the European market could transform their financial profile. The combination of immediate revenue potential from clinical testing and long-term value creation through AI-driven drug discovery positions POAI for significant growth. The established validation data and extensive biobank create high barriers to entry for competitors.

Tech Expert

The integration of AI and machine learning with live cell testing creates a powerful competitive advantage. The platform's validation against 175 FDA-approved drugs demonstrates robust real-world applicability. The ability to build multi-omic models for predicting patient survival outcomes represents advanced AI implementation in oncology.

The combination of physical biobank assets with AI-driven analysis creates a unique value proposition that's difficult to replicate. The platform's dual utility for both personalized treatment selection and drug discovery optimization showcases sophisticated AI application in healthcare, with potential for expanding into clinical decision support tools.

Initial plans target European clinical trials while providing standard testing to clinicians for individual patients

There are an estimated 250,000 gynecologic cancers diagnosed annually across Europe

PITTSBURGH, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a leader in AI-driven drug discovery, today announced plans to launch its validated flagship live cell ChemoFx® drug response assay in Europe and expanded availability in the United States. The ChemoFx® treatment selection marker and tumor profiling assay will initially focus on ovarian and other gynecological cancers and may include testing of other major tumor types of interest over time.

The ChemoFx® drug response assay is a treatment selection marker for chemotherapies that quantifies an individual cancer patients’ in vitro tumor response to various chemotherapeutic agents.

“The drug response results are critical to Predictive Oncology’s live tumor cell platform that uses AI to create predictive models of drug response to streamline and de-risk the drug discovery process,” said Dr. Arlette Uihlein, Senior Vice President of Translational Medicine and Medical Director. “Data sets extracted from these models can be applied to clinical trial design as well as biomarker discovery and companion diagnostic development efforts.”

According to the American Cancer Society, nearly 115,000 new gynecological cancer cases are diagnosed in the United States each year with more than 34,000 deaths attributed to these cancers. In Europe, an estimated 250,000 gynecologic cancer cases are diagnosed each year, the most frequent of which are endometrial, cervical and ovarian.

“Of the approximately 150,000 live cell tumor samples that Predictive has in its biobank, nearly half of those specimens are gynecological cancers, and half of those are ovarian,” said Raymond Vennare, Chief Executive officer of Predictive Oncology. “Our artificial intelligence and machine learning platform was validated against 175 FDA-approved drugs and 130 primary samples from ovarian tumors, and the use of those same data sets to build multi-omic models to predict short and long-term survival in ovarian cancer patients speaks for itself.”

By testing multiple chemotherapies on a patients’ cancer cells before treatment selection, the drug response assay helps determine which chemotherapies are more likely to be effective on the tumor and which are less likely to provide benefit to the patient.

Mr. Vennare added, “While much can be said about the significance of our biobank for drug discovery, ChemoFx® not only represents an equally crucial asset for the personalized treatment and care of cancer patients, the development of AI-driven clinical decision support tools in oncology. Both opportunities come with the potential to generate significant short-term revenue and long-term gains. When first developed and introduced to the market, ChemoFx® generated gross revenues in excess of $25 million annually.”

About Predictive Oncology

Predictive Oncology is on the cutting edge of the rapidly growing use of artificial intelligence and machine learning to expedite early biomarker and drug discovery and enable drug development for the benefit of cancer patients worldwide. The company’s proprietary AI/ML platform has been scientifically validated to predict with 92% accuracy if a tumor sample will respond to a certain drug compound, allowing for a more informed selection of drug/tumor type combinations. Together with the company’s vast biobank of more than 150,000 assay-capable heterogenous human tumor samples, Predictive Oncology offers its academic and industry partners one of the industry’s broadest AI-based drug discovery solutions, further complimented by its wholly owned CLIA laboratory facilities. Predictive Oncology is headquartered in Pittsburgh, PA. 

Contacts:

For Predictive Oncology (investors):

Tim McCarthy  

LifeSci Advisors, LLC  

tim@lifesciadvisors.com

Forward-Looking Statements: 
Certain matters discussed in this release contain forward-looking statements. These forward- looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, changes in management, plans and objectives of management are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “would,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading “Risk Factors” in our filings with the SEC. Except as expressly required by law, the company disclaims any intent or obligation to update these forward-looking statements. 

FAQ

What is the expected market size for POAI's ChemoFx® in Europe?

The European market opportunity includes approximately 250,000 gynecologic cancer cases diagnosed annually, encompassing endometrial, cervical, and ovarian cancers.

How much revenue did POAI's ChemoFx® generate in its previous market introduction?

When first developed and introduced to the market, ChemoFx® generated gross revenues exceeding $25 million annually.

How many live cell tumor samples does POAI have in its biobank?

POAI has approximately 150,000 live cell tumor samples in its biobank, with nearly half being gynecological cancers, and half of those being ovarian cancer samples.

How many FDA-approved drugs has POAI's AI platform been validated against?

POAI's artificial intelligence and machine learning platform has been validated against 175 FDA-approved drugs and 130 primary samples from ovarian tumors.

What is the initial focus of POAI's ChemoFx® launch in Europe?

The initial launch will focus on ovarian and other gynecological cancers, with plans to potentially include testing of other major tumor types over time.