TEST:

BE-Smart Esophageal Pre-Cancer screening test

"ProPhase Labs, Inc...reported its progress on the commercialization of its breakthrough BE-Smart test for esophageal cancer. The Company is aiming for commercial launch in the second half of 2024....The BE-Smart test constitutes a major innovation in the detection and management of esophageal adenocarcinoma ('EAC') and stands at the forefront of a diagnostic revolution. ProPhase intends to pursue and seeks to capture a significant share of a multi-billion-dollar market for EAC diagnostics."

"ProPhase Labs...announced important developments in the Company’s efforts to commercialize its novel BE-SMART esophageal cancer diagnostic test. BE-Smart is a novel diagnostic test that is intended to detect and quantify early signs of certain types of cancer in individuals with Barrett's esophagus, a condition known to significantly increase the risk of developing esophageal cancer. This breakthrough test, in development for nearly five years, is nearing completion of clinical studies. If the clinical trial results are successful, the Company will be aiming for commercial launch during 2024....The United States Patent and Trademark Office (USPTO) has granted ProPhase Labs a patent safeguarding the BE-Smart technology and extending protection to similar biomarker discovery processes for various diseases."

"...anticipate an acceleration in growth at both Nebula Genomics and Pharmaloz Manufacturing, as well as commercialization of our BE-SMART esophageal cancer test, during 2024."

Investor Presentation: Go to market strategy to commercialize BEsmart - partner with large diagnostic laboratory with a well established sales force in GI fields in 1H 2024

Investor Presentation: Goal to receive CPT codes for insurance reimbursement by Q1 2024

"ProPhase Labs...announced it will be giving a data presentation at the United States and Canadian Academy of Pathology (USCAP), which is being held March 11 – 16, 2023, at the Ernest N. Morial Convention Center in New Orleans, LA."

"ProPhase Labs...announced a collaboration with mProbe, Inc...and Dr. Christopher Hartley of Mayo Clinic for the continued development of its BE-Smart Esophageal Pre-Cancer Diagnostic Screening test...mProbe plans to continue testing specimens provided by the Mayo Clinic in the first quarter of 2023. ProPhase Labs intends to pursue initial commercialization of the BE-Smart test as a laboratory developed test (LDT) and for research use only (RUO) in the third quarter of 2023, once 500 specimens have been tested by mProbe."

"ProPhase Labs...announced that its flagship diagnostic test, which is undergoing clinical validation as a laboratory developed test (LDT) for esophageal cancer screening, was featured in International Journal of Molecular Science (MDPI Open-Access Publishing), volume 24, no. 4 edition. The article highlights the current clinical limitations and future molecular innovations of Barrett’s esophagus-related cancer. The authors note that progress has been made regarding genomic, transcriptomic, and proteomic approaches for molecular diagnostics of Barrett’s-related esophageal cancer as some of these research innovations and findings could be translated into full clinical adoption."

"ProPhase Labs...announced it has completed its previously announced acquisition of the world-wide exclusive rights to the BE-Smart Esophageal Pre-Cancer diagnostic screening test and related intellectual property assets from Stella Diagnostics, Inc. ('Stella')."

"ProPhase Labs...today announced that it has entered into an asset purchase agreement to acquire from Stella Diagnostics, Inc. ('Stella') world-wide exclusive rights to Stella’s BE-Smart Esophageal Pre-Cancer diagnostic screening test and related intellectual property assets for approximately $4.5 million dollars, comprised of approximately $3.5 million in cash and $1 million in ProPhase common stock."