A “sandbox” for innovation: The Advanced Diagnostics Laboratory
The Advanced Diagnostics Laboratory (ADL) is a visionary space designed to continue Mayo Clinic’s long tradition of pioneering patient treatments and diagnostics. The ADL’s mission is to foster innovation — including grassroots innovation — across different specialties, through partnerships in-house as well as with external companies. Located on the third floor of One Discovery Square in a 9,600-square-foot space, the lab was born out of an initiative between Mayo’s Department of Laboratory Medicine and Pathology (DLMP) and the Center for Individualized Medicine (CIM).
“New disruptive technologies and industry collaborations are keys to our success in innovation,” says Kathy Bates, senior director of Laboratory Services and Partnership Development in DLMP and administrator of the ADL. “This space has room and resources for evaluating technology quickly, enabling us early access to technology and the opportunity to test it, with the potential to influence the final product. These resources allow us to strike more business agreements and co-development relationships, move quickly, and bring more capabilities to the collaboration.”
Kathy Bates, administrator of the ADL
Co-development agreements have already been struck with, for example, Numares, a German-based company that is leveraging nuclear magnetic resonance (NMR) technology, using AI to quantify “metabolite constellations” and, thus, help patients with undiagnosed diseases or conditions; Breath Diagnostics, a medical device company in Kentucky that is developing a test to detect lung cancer using patients’ exhaled breath; and more recently, Thermo Fisher Scientific.
“Thermo Fisher is a very innovative, large diagnostic company that DLMP has worked with for a number of years,” says Bates. “The challenges of the COVID pandemic really strengthened our relationship. So we recently executed an updated agreement with Thermo Fisher to focus on innovation and develop novel tests on three of their technology platforms — next-generation sequencing (NGS), mass spectrometry, and allergy and autoimmunity diagnostic tools.”
The collaboration is part of Mayo Clinic’s movement towards “precision medicine” and is aimed at advancing such diagnostics in a clinically relevant, globally accessible manner.
Benjamin Kipp, Ph.D., is director of the ADL. “I think a lot of these companies have really cool projects, but we have to push the boundaries, we have to know where they fail, and we have to know where they work so that we can implement them for our patients,” he says.
Designed as a “flexible” space, the ADL moves beyond a traditional lab model: it can be quickly modified to meet each project’s needs. It’s also a think tank, a fulcrum for new ideas — which is why its office area features entire walls of whiteboard to help capture ideas and cultivate discussion. The larger environment of One Discovery Square is a vibrant, collaborative atmosphere that encourages various companies, educators, and researchers to cross-pollinate ideas and innovation in diagnostic and biomedical technologies.
“We needed to create an environment that was more of a ‘sandbox,’ if you will — something that has more flexibility, which used to live within the clinical labs but really does not anymore,” says William Morice, II, M.D., Ph.D., chair of DLMP and president of Mayo Clinic Laboratories. “The ADL is really an attempt to try and bring these innovative technologies and some of these resources into an environment that’s more flexible so we can adapt to what the clinicians are asking of us.”
When the pandemic emerged last year, the lab’s nimble design allowed its staff of multidisciplinary experts to pivot their efforts to the crisis.
“Throughout the pandemic, we developed and launched a significant amount of novel COVID tests,” says Bates. “The ADL was in the right place at the right time because we could pivot and focus on developing tests for COVID, working with experts and colleagues across DLMP, CIM, and with the clinicians.”
One milestone test was the validation of dried blood spots (DBS) as a specimen source for self-collection. DBS had already been used for newborn screening since the 1960s, but ADL staff, working with scientists from the Biochemical Genomics Laboratory, were able to convert its use for serology testing, which was used as a Mayo employee surveillance to detect exposure to the COVID-19 virus. The ADL staff also worked closely with colleagues from Laboratory Services, Partnership Development, and Supply Chain Management to evaluate a number of point-of-care devices focused on COVID-19.
The COVID-19 crisis also reflects the ADL’s ability to bring together different areas of expertise, different technologies, and different labs to develop new tests and help grow innovations beyond its own physical walls.
“The ADL is the physical space and a key part of our innovation strategy,” says Bates. “However, the innovation projects may also be performed outside of our walls with support from ADL. The RFA (request for applications) process stimulates grassroots innovation and comes from across DLMP and CIM. ADL is still fostering innovation as our team (led by operations manager Jessica Lesko) provides support. And ADL funds those projects. We also provide project management support, tracking the progress of each project, and we have a very fine-tuned series of milestones (with three-month intervals at minimum) and associated metrics.”
Jessica Lesko, operations manager of the ADL, and Benjamin Kipp, Ph.D., director of the ADL
Another important contributor to the innovation strategy is the ADL Advisory Committee, made up of physicians and scientists from DLMP, CIM, and from all Mayo Clinic campuses. All committee members are leaders in their respective fields who have an expert understanding of laboratory technologies. Having such a diverse committee helps communicate great ideas and build innovation projects collectively. “We bring this group together to identify the key, game-changing, disruptive technologies that we should be aware of — and seeking — to remain relevant in the market,” says Bates.
Scott Beck is senior vice president of Mayo Clinic Laboratories. “The idea is to bring transparency and balance to how we innovate test development,” he says, “and to combine the ideation from people who really understand the technologies with the top-down opportunities to align those ideas with broader strategy. We want to make sure we have the resources available to support what needs to be done.”
Disruptive technologies, by their very nature, break from the status quo and introduce new ways of doing something. Hence, exploring this area means greater investment risk.
“The ADL is really designed to think about high-risk, high-reward projects; projects that maybe encompass more than one disease. For example, all of solid tumors or all of hemoglobinopathies,” says Dr. Kipp. “They are risky because they’re expensive, and there are a lot of different markers being assessed for. The technologies are new; we don’t know how they’re going to work. But at the end of the day, I think the information you learn from these types of studies is going to be very important for the clinic.”
Dr. Morice agrees. “The ADL shouldn’t be just another place to do test development,” he says. “It’s a place to invest in innovation that could fail. But that outcome would be considered a sign of success because we are pushing the envelope.”
The challenge has been to find a way to bear that burden of risk while linking inventiveness back into the institution of Mayo Clinic. This lab space answers that challenge.
“The ADL represents Mayo Clinic’s way of responding to these disruptive technologies in a very nimble way so that we can bring these innovations back into those systems that we know work for delivering the best possible patient care,” Dr. Morice says. “It’s a place where we can move dreams into action, where we can insource these technologies that have promise and start to use them and explore their use in patient care. And if it is the next big thing, then we will be ready and know how to use it. In the end, it’s about what’s best for the patients.”
One milestone example of a novel test that will significantly impact patient care is the MayoComplete Solid Tumor Panel, the largest next-generation sequencing (NGS) solid tumor panel now offered by Mayo Clinic Laboratories. The panel is essentially five assays in one. It detects single nucleotide variants and small insertions and deletions within 514 genes. That includes more than 350 genes not previously reported by a Mayo NGS solid tumor assay. It is the first such test to provide tumor mutational burden status, and will help physicians understand the unique genetic features of patients’ tumors — essential when choosing the most effective treatment from an array of options.
The MayoComplete well represents ADL’s nimbleness and ability to foster innovation across different labs. Why? More than 100 Mayo staff members from the Division of Laboratory Genetics and Genomics, and Genomics and Bioinformatics Services, contributed to the panel’s development.
“The work this team has accomplished to develop the MayoComplete Solid Tumor Panel has been no small feat,” says Kevin Halling, M.D., Ph.D., Laboratory Genetics and Genomics, who led the project. “The dedication and diligence of this team is a true testament to ‘the needs of the patient come first,’ as this test will aid in the diagnosis, treatment, and management of cancer patients.”
After a long pandemic year, the ADL can now broaden its focus across other horizons.
“As we move through the pandemic, we’re now turning toward developing other innovations outside of COVID,” says Bates. “The ADL will have the most impact on patients’ lives by looking for innovation, by being innovative, to bring promising tests and services to our patients, both within the practice and for the patients we serve through Mayo Clinic Laboratories. We want to be innovative and also address an unmet clinical need.”
Guided by a patient-centric philosophy, Mayo Clinic Laboratories has a unique internal structure of quality specialists, coordinators, and engineers who constantly evaluate and improve laboratory operations. This structure supports a host of quality assurance activities.
Each day, some 40 to 45 thousand specimens are shipped to Mayo Clinic Laboratories in Rochester, Minnesota, from hospitals and other health care organizations around the world. And for every sample, there’s a patient to whom it belongs, someone on the other end hoping for answers to a challenging, perhaps even life-threatening, condition.