Predictive Oncology Announces Planned European Launch of its ChemoFx® Treatment Selection Marker and Tumor Profiling Assay
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.
Predictive Oncology (NASDAQ: POAI) ha annunciato piani per lanciare il suo test di risposta ai farmaci ChemoFx® in Europa e ampliarne la disponibilità negli Stati Uniti. Il test, inizialmente focalizzato sui tumori ginecologici, valuta le risposte dei tumori dei singoli pazienti oncologici a varie chemioterapie prima della selezione del trattamento.
La biobanca dell'azienda contiene circa 150.000 campioni di tumori a cellule vive, con quasi la metà riguardante i tumori ginecologici. La piattaforma è stata validata con 175 farmaci approvati dalla FDA e 130 campioni di tumori ovarici primari. L'opportunità di mercato è significativa, con circa 115.000 nuovi casi di tumori ginecologici ogni anno negli Stati Uniti e 250.000 in Europa.
Secondo il CEO Raymond Vennare, quando è stata precedentemente lanciata sul mercato, ChemoFx® ha generato ricavi lordi superiori ai 25 milioni di dollari all'anno. La tecnologia ha un duplice scopo: il trattamento personalizzato del cancro e lo sviluppo di strumenti di supporto decisionale clinico guidati da IA in oncologia.
Predictive Oncology (NASDAQ: POAI) ha anunciado planes para lanzar su ensayo de respuesta a medicamentos ChemoFx® en Europa y ampliar su disponibilidad en los Estados Unidos. El ensayo, que se centra inicialmente en los cánceres ginecológicos, evalúa las respuestas de los tumores de los pacientes de cáncer individuales a varias quimioterapias antes de la selección del tratamiento.
El biobanco de la compañía contiene aproximadamente 150,000 muestras de tumores de células vivas, siendo casi la mitad cánceres ginecológicos. La plataforma ha sido validada con 175 fármacos aprobados por la FDA y 130 muestras primarias de tumores ováricos. La oportunidad de mercado es significativa, con alrededor de 115,000 nuevos casos de cáncer ginecológico anualmente en los EE.UU. y 250,000 en Europa.
Según el CEO Raymond Vennare, cuando se introdujo anteriormente en el mercado, ChemoFx® generó ingresos brutos superiores a $25 millones anuales. La tecnología cumple dos propósitos: el tratamiento personalizado del cáncer y el desarrollo de herramientas de apoyo a la decisión clínica impulsadas por IA en oncología.
Predictive Oncology (NASDAQ: POAI)는 ChemoFx® 약물 반응 검사 를 유럽에서 출시하고 미국 내 가용성을 확대할 계획을 발표했습니다. 이 검사는 처음에 부인 종양에 중점을 두고, 치료 선택 이전에 개별 암 환자의 종양 반응을 다양한 항암제에 대해 검사합니다.
이 회사의 바이오뱅크는 약 150,000개의 살아 있는 세포 종양 샘플을 포함하고 있으며, 그 중 거의 절반이 부인 종양입니다. 이 플랫폼은 FDA 승인을 받은 175개 약물과 130개의 원발성 난소 종양 샘플에 대해 검증되었습니다. 시장 기회는 미국에서 매년 약 115,000건, 유럽에서 250,000건의 새로운 부인 종양 사례가 발생하는 것으로 상당합니다.
CEO 레이몬드 베나레에 따르면, ChemoFx®가 시장에 이전에 소개되었을 때, 연간 2,500만 달러 이상의 매출을 올렸습니다. 이 기술은 개인 맞춤형 암 치료와 종양학에서 AI 기반 임상 의사 결정 지원 도구 개발이라는 두 가지 목적을 가지고 있습니다.
Predictive Oncology (NASDAQ: POAI) a annoncé des plans pour lancer son test de réponse médicamenteuse ChemoFx® en Europe et élargir sa disponibilité aux États-Unis. Le test, initialement axé sur les cancers gynécologiques, évalue les réponses tumorales des patients cancéreux individuels à diverses chimiothérapies avant la sélection du traitement.
La biobanque de l'entreprise contient environ 150 000 échantillons de tumeurs de cellules vivantes, dont près de la moitié concernent des cancers gynécologiques. La plateforme a été validée avec 175 médicaments approuvés par la FDA et 130 échantillons de tumeurs ovariennes primaires. L'opportunité de marché est significative, avec environ 115 000 nouveaux cas de cancer gynécologique chaque année aux États-Unis et 250 000 en Europe.
Selon le PDG Raymond Vennare, lorsque ChemoFx® a été précédemment lancé sur le marché, il a généré des revenus bruts supérieurs à 25 millions de dollars par an. La technologie a double fonction : traitement personnalisé du cancer et développement d'outils d'aide à la décision clinique pilotés par IA en oncologie.
Predictive Oncology (NASDAQ: POAI) hat Pläne angekündigt, seinen ChemoFx® Arzneimittelreaktionstest in Europa einzuführen und die Verfügbarkeit in den Vereinigten Staaten zu erweitern. Der Test, der sich zunächst auf gynäkologische Krebserkrankungen konzentriert, prüft die Tumorreaktionen einzelner Krebspatienten auf verschiedene Chemotherapien vor der Behandlungsauswahl.
Die Biobank des Unternehmens enthält etwa 150.000 lebende Zelltumormuster, von denen fast die Hälfte gynäkologische Krebserkrankungen sind. Die Plattform wurde gegen 175 von der FDA zugelassene Medikamente und 130 primäre Ovarialtumorproben validiert. Die Marktchance ist erheblich, mit etwa 115.000 neuen Fällen von gynäkologischem Krebs jährlich in den USA und 250.000 in Europa.
Laut CEO Raymond Vennare hat ChemoFx®, als es zuvor auf den Markt gebracht wurde, jährlich Bruttoumsätze von über 25 Millionen Dollar generiert. Die Technologie erfüllt zwei Zwecke: personalisierte Krebsbehandlungen und die Entwicklung von KI-gesteuerten klinischen Entscheidungsunterstützungstools in der Onkologie.
- 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
- None.
Insights
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
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.
This expansion represents a significant revenue opportunity for POAI, particularly given the historical precedent of
For a company with a market cap of just
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
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
Contacts:
For Predictive Oncology (investors):
Tim McCarthy
LifeSci Advisors, LLC
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.
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