Expression Pathology, a leader in tissue proteomic analysis, today announced Mayo Clinic has licensed non-exclusive rights to Expression Pathology's Liquid Tissue® patent for use in diagnosis of systemic amyloidosis in formalin-fixed tissue.
Patented Liquid Tissue® methodology enables solubilization of proteins for mass spectrometric analysis of formalin-fixed paraffin-embedded (FFPE) tissue, the standard form of preserved patient tissue used in clinical pathology testing worldwide. Mayo Clinic has applied the technology to develop a specific and sensitive mass spectrometry based method for diagnosis and classification of amyloidosis in routine biopsy specimens, in a format that is rapid and readily applicable in a clinical setting. This test is being offered to patients worldwide through Mayo Medical Laboratories, Mayo Clinic's reference laboratory.
With 50,000 diagnosed cases every year worldwide amyloidosis can be a localized or systemic disease, characterized by organ function impairment, sometimes as severe as cardiac and/or renal failure. Subtyping of cases is critical as management of the disease differs radically, from drug therapies to major organ transplants.
The new Liquid Tissue-based method aids in treatment decisions as it exhibits greater sensitivity and specificity than the traditional IHC based classification. In an early case study of 56 FFPE cardiac biopsies involving amyloidosis immunohistochemistry was diagnostic in 19/52 cases and equivocal in 33/52 cases (4 cases no IHC). The mass spectrometry-based Liquid Tissue method identified the amyloidosis type in 53 of 56 cases studied.
"Detailed mass spectrometry analysis of proteins related to specific disease conditions in FFPE tissue is opening huge opportunities in personalized medicine to relate those measurements to patient treatment decisions," said Casey Eitner, President and CEO of Expression Pathology. "We are delighted that Mayo Clinic has applied our Liquid Tissue® methodology to solve a difficult medical problem."
Financial terms of the agreement were not disclosed.
Expression Pathology Inc.