ProPhase Labs' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by ProPhase Labs (PRPH).
Over the past two years, ProPhase Labs has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BE-Smart. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BE-Smart FDA Regulatory Events
BE-Smart is a drug developed by ProPhase Labs for the following indication: esophageal cancer test.
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:
- BE-Smart
- Announced Date:
- October 22, 2025
- Indication:
- esophageal cancer test
Announcement
ProPhase Labs Inc. announced today that its pivotal clinical study by Hartley et al. (2025) validating the BE-Smart™ esophageal cancer test has been accepted for publication in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association.
AI Summary
ProPhase Labs announced that its pivotal clinical study by Hartley et al. (2025), validating the BE-Smart™ esophageal cancer test, has been accepted for publication in Clinical Gastroenterology and Hepatology. The study shows BE-Smart achieved 100% sensitivity in detecting patients who later developed cancer and demonstrated strong predictive accuracy with an AUC up to 1.0. BE-Smart is an eight-protein, mass-spectrometry assay that stratifies the risk of progression from Barrett’s Esophagus to high-grade dysplasia or esophageal adenocarcinoma. With millions of endoscopies performed annually for GERD and Barrett’s surveillance, the test targets a multibillion-dollar market. ProPhase is advancing regulatory filings, scaling its laboratory operations and partnering with leading gastroenterology practices. A phased commercial rollout is planned for 2026, allowing physicians to order BE-Smart through standard pathology channels. This milestone sets the stage for revenue growth and wider access to advanced molecular screening.
Read Announcement
ProPhase Labs FDA Events - Frequently Asked Questions
As of now, ProPhase Labs (PRPH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, ProPhase Labs (PRPH) has reported FDA regulatory activity for BE-Smart.
The most recent FDA-related event for ProPhase Labs occurred on October 22, 2025, involving BE-Smart. The update was categorized as "Clinical Study," with the company reporting: "ProPhase Labs Inc. announced today that its pivotal clinical study by Hartley et al. (2025) validating the BE-Smart™ esophageal cancer test has been accepted for publication in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association."
Currently, ProPhase Labs has one therapy (BE-Smart) targeting the following condition: esophageal cancer test.
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:PRPH) was last updated on 10/22/2025 by MarketBeat.com Staff
