A Medical Device Daily
ARUP Laboratories (ARUP; Salt Lake City) and Saladax Biomedical (SBI; Bethlehem, Pennsylvania) reported entering a multi-year licensing agreement for SBI antibodies against busulfan and other raw materials that will enable ARUP to develop a specialized test for measuring serum concentrations of the cancer chemotherapeutic agent busulfan (Busulfex, Myleran).
The busulfan test to be developed and offered by ARUP is expected to enable more timely and cost-effective management of busulfan dosing. ARUP will advance SBI an undisclosed up-front licensing fee, with additional payments for the supply of SBI materials.
Saladax will supply ARUP with the raw materials necessary to develop and validate a microtiter plate assay to measure the concentrations of busulfan in the bloodstream of patients undergoing allogeneic hematopoeitic stem cell transplant (HSCT) for chronic myelogenous leukemia (CML).
ARUP will be the first reference laboratory in the world, it said, to offer a busulfan blood level monitoring test, based upon antibodies rather than physical methods such as high performance liquid chromatography (HPLC).
Current testing methods require long lead times, often yielding results too late to adjust dose and reduce toxic side-effects of the treatment, which can be lethal in some patients.
Annually, more than 60,000 hematopoeitic stem cell transplants are performed worldwide, with about 30% performed in the U.S. Busulfan is commonly used in the preparative regimen prior to transplant.
The drug can be quite toxic, particularly in pediatric patients, for whom dose management by blood level monitoring is recommended, the company said.
ARUP is a national clinical and anatomic pathology reference lab and an enterprise of the University of Utah and its Department of Pathology. It offers more than 2,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays.
Saladax Biomedica is a research-based diagnostics company.
In other agreements news: Knowledge Factor (Denver), focused on confidence-based learning, said that it has expanded its relationship with New England Organ Bank (NEOB; Newton, Massachusetts) for a training program to validate that employees have 100% mastery when it comes to understanding the process and procedures related to the screening and procurement for heart and pericardium tissue recovery.
The program utilizes Knowledge Factor’s patented Confidence-Based Learning process to remediate confidently-held misinformation that can lead to serious mistakes.
“In pericardium and heart tissue recovery, swift and accurate action saves lives,” said Diana Buck, director of Tissue Operations of New England Organ Bank.
The launch of the Heart and Pericardium Tissue Recovery program follows on the heels of NEOB and Knowledge Factor’s successful introduction of a mastery program on the process and procedures around tissue donor eligibility.
The new program, funded by LifeNet (Virginia Beach, Virginia) and CryoLife (Kennesaw, Georgia) will be available to all NEOB, LifeNet and CryoLife employees and partners in February.