FDA Events for Predictive Oncology (POAI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Predictive Oncology (POAI).
Over the past two years, Predictive Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ChemoFx. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ChemoFx - FDA Regulatory Timeline and Events
ChemoFx is a drug developed by Predictive Oncology for the following indication: Treatment Selection Marker and Tumor Profiling Assay.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ChemoFx
- Announced Date:
- January 16, 2025
- Indication:
- Treatment Selection Marker and Tumor Profiling Assay
Announcement
Predictive Oncology announced plans to launch its validated flagship live cell ChemoFx® drug response assay in Europe and expanded availability in the United States.
AI Summary
Predictive Oncology Inc. announced plans to expand access to its validated live cell ChemoFx® drug response assay. This assay tests a patient’s tumor cells with multiple chemotherapies to predict the most effective treatment. Initially designed to focus on ovarian and other gynecologic cancers, the assay is set to launch in Europe as part of clinical trials while expanding its availability for individual patient testing in the United States.
The ChemoFx® assay is a key part of the company’s AI-driven platform that analyzes live tumor cells to build predictive models of drug response. By providing critical data on how a tumor may respond to different chemotherapies, the test helps clinicians choose better treatment options. This expansion aims to improve personalized cancer care and support more informed decision-making in oncology.
Read Announcement
Predictive Oncology FDA Events - Frequently Asked Questions
As of now, Predictive Oncology (POAI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Predictive Oncology (POAI) has reported FDA regulatory activity for ChemoFx.
The most recent FDA-related event for Predictive Oncology occurred on January 16, 2025, involving ChemoFx. The update was categorized as "Provided Update," with the company reporting: "Predictive Oncology announced plans to launch its validated flagship live cell ChemoFx® drug response assay in Europe and expanded availability in the United States."
Currently, Predictive Oncology has one therapy (ChemoFx) targeting the following condition: Treatment Selection Marker and Tumor Profiling Assay.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:POAI) was last updated on 7/11/2025 by MarketBeat.com Staff
