ProPhase Labs Announces Significant Progress in BE-Smart Esophageal Cancer Test Development USPTO grants additional broad patents for BE-SMART - Seite 2

-As a laboratory-developed test (“LDT”), BE-Smart will continue to develop and adapt to new potential protein markers that may arise after the completion of the RNA-Seq data analysis currently being conducted at the Mayo Clinic.

Future Directions and Impact:

As an LDT, BE-Smart's flexibility allows for the incorporation of emerging protein markers, enhancing its diagnostic power. ProPhase anticipates the completion of Genesis Biotechnology Group's analysis by early Q2, followed by subsequent strategic collaborations to then secure reimbursement rates and enable wide-scale adoption of the test. BE-Smart uses high throughput mass spectrometer technology that we believe will enhance national deployment, targeting over 20 million Americans monitored for Barrett's esophagus.

“A recent Wall Street Journal op-ed from February 2, 2024 spoke about early cancer detection and improving survival rates, but BE-SMART does one better, it detects hallmarks of carcinogenesis before it even develops, allowing for a simple procedure to remove the potentially dangerous cells, a true game changer for gastroenterology, “said Ted Karkus, CEO of ProPhase Labs. “We believe that BE-Smart potentially solves many of the problems that plague other tests in the field, our test doesn’t need multiple samples and the test isn’t limited by staining and subjective diagnosis. BE-Smart requires only a small amount of tissue for testing and allows for extremely high throughput. Once commercialized, our goal is for this to be the standard of care test used on the over 20 million people being monitored by gastroenterologists for Barrett’s esophagus. If we are able to attain reimbursement rates of just $1,000 - $2,000, which cannot be assured, the initial addressable US market alone represents an enormous market for us.” Mr. Karkus concluded. 

About the BE-Smart Test

The BE-Smart Esophageal Pre-Cancer Diagnostic Screening test is aimed at early detection of esophageal cancer. It has already been tested by an independent test lab, mProbe, Inc. on over 200 human samples and has shown an area under curve of greater than 99%¹ in distinguishing highly impactful histologic classifications. ProPhase Labs plans to pursue initial commercialization of the BE-Smart test as an LDT. The goal of widespread adoption of the BE-Smart diagnostic test would allow health care providers to initiate potentially lifesaving early treatment processes such as an ablation procedure to remove the precancerous cells and could also significantly reduce unnecessary endoscopies.