NEW YORK — ProPhase Labs said on Wednesday that it has partnered with mProbe and researchers at the Mayo Clinic to further develop an esophageal cancer screening test.
The mass spectrometry-based proteomic assay, called the BE-Smart Esophageal Pre-Cancer Screening test, is designed for the early detection of esophageal cancer. The test was originally developed by Stella Diagnostics, which worked with mProbe and the Mayo Clinic on its validation and optimization.
ProPhase acquired the rights to the test in late 2022 for $4.5 million. The Doylestown, Pennsylvania-based company said that, under the terms of their latest deal, mProbe will continue evaluating the test using specimens provided by the Mayo Clinic.
ProPhase said that it expects to pursue initial commercialization of the BE-Smart test as a laboratory-developed test and for research use only once mProbe has tested 500 specimens, which is expected by the third quarter of the year.
Full commercialization of the test as an LDT with coverage from insurers is expected by mid-2024, after the test has been evaluated in 1,000 specimens, ProPhase added.
ProPhase "expects to pursue reimbursement rates in the range of $1,000 to $2,000 per test, based on CPT codes of similarly complex tests and with gross profit margins approaching 75 percent as volumes grow," ProPhase CEO Ted Karkus said in a statement. "Our initial target market is 2 million endoscopies performed annually on patients with Barrett's esophagus, which equates to a $2 billion to $4 billion potential market just in the US."