Lab test could change immunology
Imagine using a hand-drawn sketch to identify a person in a crowd.
Now imagine switching to a high-resolution photo to make a match.
That's the shift some researchers at Mayo Clinic and the England-based The Binding Site firm are hoping to make in diagnosing and tracking the progression of multiple myeloma cancer in patients.
"It's night and day difference in terms of the resolution," Dr. David Murray said of using a mass spectrometer versus the decades-old process of gel electrophoresis.
Murray and David Barnidge, Ph.D, have invented a new testing process that uses the mass spectrometer to look for the build up of monoclonal immunoglobulin or "M-Proteins," which can signal the development of the currently incurable cancer in a patient.
They created it in Mayo Clinic's labs in the Hilton Building. Mayo Clinic patented the process, and now it's working with its longtime collaborator The Binding Site to fine-tune the test and eventually work toward having it approved by the U.S. Food and Drug Administration. Mayo Clinic has financial investment in the project. The collaboration uses patents owned by Mayo Clinic and The Binding Site, plus several patents jointly held by both organizations.
The collaboration has spurred The Binding Site to establish a research laboratory in northwest Rochester to focus on the project. In May, a 5,200-square-foot lab was built out in the first level of the Wideth Smith Nolting Building, formerly the Home Design Center, along West Circle Drive.
"It all just came together," said Barnidge, standing in blindingly white new laboratory space. Barnidge, who now works for The Binding Site as laboratory director, is outfitting the lab with the necessary equipment and hiring seven researchers to staff it.
Brian DuChateau, the vice president of development for The Binding Site, explains the progression of the collaboration as going through three phases.
"First, it was negotiating terms with Mayo. The next phase is to locate, build and establish the Rochester lab," DuChateau said. "The third phase is development and validation of the test. That's the fun part we're looking forward to getting to."
However, he cautions it probably will take years before the test is considered by the FDA for approval.
Meanwhile, Mayo Clinic is working on a parallel to gain approval to use the test just for its patients. Murray said that separate process could wrap up by the end of 2017.
"We're leading the charge. We want to eventually get this thing out in the hands of the other institutions," Murray said.
This approach stems from when a medical resident with an unusual background arrived at Mayo Clinic's Protein Immunology Lab and saw they were using the gel electrophoresis that dates back to the late 1950s.
Long before becoming a physician, Murray earned a doctorate in chemistry, and he worked as a research chemist for Eastman in Tennessee. After 10 years in that job, he "got the crazy idea to go to medical school." That led him to see how the immunology lab was doing its testing.
"As an industrial chemist, it was like, I knew there were much better ways to do this," he said.
He soon joined forces with Barnidge, as well as Mayo Clinic's Dr. John Mills and others. They soon started doing things with a mass spectrometer that had never been done before. By 2014, they had worked out a new test.
Overall, Barnidge and Murray say their patented test is more efficient, faster and less expensive than the ones in use now. Plus, there is detail that is just not possible with the gels.
"We're seeing details that we've never see before about the antibody repertoire. There are things that I think eventually will change how we think about immunology," said Murray.
DuChateau said this process could open the door for many new tests.
"It's the ultimate diagnostic. If you can ionize it, in theory, you can use this for a lot of different things. Ultimately, this is not just one single project for our Rochester lab," he said.