Whether it’s developing fit-for-purpose, customized flow assays, or optimizing the most appropriate off-the-shelf assay, the Labcorp Central Laboratory Services flow cytometry specialty testing team generates high-quality, clinically relevant and actionable data for your drug development programs. Here, we discuss how we choose our flow cytometry instruments to execute multi-site operations and extract the most data possible from limited clinical samples.
A closer look at our flow cytometry specialty testing capabilities
A wide range of flow cytometry applications is performed at each of our five laboratory locations. These include enumeration assays, high sensitivity minimal residual disease testing, immunophenotyping, functional testing, and drug target occupancy assays. These services are provided across a global network of five central labs, along with a central development and validation lab, to facilitate large-scale clinical studies. Despite having a multi-center operation, utmost care is taken to limit variability in protocols and results, making it possible to reliably compare data across sites.
“We’re able to offer a wide range of applications at our different sites,” says Nathan Kozman, Laboratory Technology Manager, Central Labs. “Our global footprint allows us to perform clinical studies at a much larger scale. Wherever our clients need testing, we’re able to provide that. Plus, we maintain data quality across each of these sites, making it possible for us to compare the data.”
In addition to skilled scientists, operational staff, and data analysts, this expansive multi-site flow cytometry capability is shouldered by an array of high-performing instruments. Before they are onboarded, however, these technologies need to meet specific requirements.
Flow cytometry instrumentation at Labcorp Central Labs: Eight key considerations
Before an instrument is considered for purchase, a cross-functional team presents their prerequisites. “In a central lab environment where hundreds of samples are processed daily, our decision is heavily weighted towards the operational capability of the instrument and the quality of the data it outputs,” says Yoav Peretz, PhD, Global Scientific Director for Flow Cytometry. “This includes a variety of factors including system optics, fluidics, multiplexing and sample loading features, instrument maintenance and instrument support.”
At Labcorp Central Labs, we consider these instrument attributes before selecting flow cytometry instruments:
1. Compliance with regulatory requirements
Confirming system compliance with regulatory requirements is one of the foremost steps in the decision-making process. Given the global nature of our operation, it is also necessary to uphold country-specific regulatory standards. “Our instruments are standardized globally. This means, the results of a cohort being run in the US can be compared to that being run in, say, China. When we validate and transfer tests, we take particular steps to facilitate cross-comparison across instruments effectively minimizing instrument and operator variability during sample testing,” says Dr. Peretz.
2. Vendor reputation for data quality
Due to Labcorp’s decades of experience in the industry, we have working relationships with top technology providers. Among the many variables, data quality is, by far, a non-negotiable aspect of instrument performance, and is directly influenced by the sensitivity and high-resolution capabilities of the system.
3. Multiplexing capabilities
In clinical applications, the more information that can be gathered from a single sample, the better. “When we need to ask targeted questions, we use instruments that have 8 to 12 color capabilities,” explains Dr. Peretz. “We also have systems with 27-color capabilities that allow us to cast a wider net and multiplex a multitude of proteins in our tests. With these more advanced optical systems, we’re able to simultaneously monitor multiple arms of the immune system during a clinical trial with fewer sample.”
“Higher multiplexing capabilities can sometimes also require larger sample volumes, which can be operationally quite challenging during a clinical study,” notes Cristina Hedin, MS, Global Director for Operations in Flow Cytometry and Targeted Cell Isolation. “We choose instruments that require the least possible sample volume for multiplexing.”
4. Sample loading flexibility
Given the diverse nature of projects ongoing at Labcorp Central Labs, flow cytometers that offer flexibility in sample loading formats are preferred. To avoid workflow bottlenecks, running the high volume of tests requires instruments with integrated sample loaders for tubes, or for 96-, 384- or deep-well plates.
5. Sample acquisition speed
The time taken to generate each data point becomes an important variable in a high-throughput, busy laboratory. Instruments need to deliver faster speeds without compromising on data quality. At Labcorp Central Labs, flow cytometry instruments exhibit high sample acquisition rates.
6. Software compatibility and ease of use
The instrument’s accompanying software needs to be intuitive, easy-to-use, and scalable across teams. Software platforms that have a simple, user-friendly interface are more suitable for scientific staff to work with on a daily basis and even perform troubleshooting without requiring technical assistance. Moreover, the software needs to be in alignment with the team’s daily operations so that there are little to no workflow interruptions during the onboarding process.
7. Interfacing with current instruments
The data generated by a new instrument needs to build into the current data flow of the laboratory. For this, ‘data rules’ are set, and file formats are adjusted during a process known as interfacing.
Before an investment is made, the technology team at Central Labs views the instrument through the lens of automation for both analytical steps and data processing. “We nominate automation systems that can increase efficiency, reduce turnaround time and ultimately, get us results as quickly as possible,” says Kozman.
Although that is a long list of desirable features, when it comes to choosing a flow cytometry instrument for clinical studies, quality much be paramount. “What matters most at the clinical stage is being able to focus on and reliably obtain the most critical data points for the study,” says Hedin.
After narrowing down instruments that fit the above criteria, a formal assessmentis performed to test parameters and operational capabilities. Once these are completed, the instruments are ready to be used within Labcorp Central Labs.
Keeping up with the latest developments for regular upgrades
At Labcorp Central Labs, our scientists engage in continued learning to stay updated on the latest scientific and technological developments in flow cytometry. In doing so, team members regularly bring novel approaches or upgrade suggestions to current techniques.
Here are a few ways in which the team stays informed:
Conferences: Our scientific team members present at and attend leading scientific conferences in flow cytometry, such as CYTO, and maintain active memberships in international cytometry associations.
Regular internal meetings: Pooling the diverse knowledge base of Labcorp’s international experts, we set up meetings dedicated to refining our processes and workflows, and addressing the current and future needs of our clients.
Collaboration with early-stage drug development teams: We also communicate closely with our colleagues in biomarker or preclinical laboratories about the latest technologies implemented during exploratory phases. This knowledge helps us anticipate potential changes on our end as, in due time, these technologies become relevant for clinical applications as well.
Relationships with technical providers: We often collaborate with our vendor partners on training projects for technical upskilling following an instrument upgrade. In addition to our ongoing relationships with current vendors, we openly welcome demonstrations of innovative technologies developed by emerging companies that can save time during pre-analytical, analytical, or post-analytical stages.
Our continued commitment to high-quality clinical data and efficient workflows
Labcorp Central Labs will continue to implement projects that boost performance and overall productivity at each site. One such project is focused on creating a new curated format for clients to easily view the vast amounts of reportable data generated from multiplex experiments.
As technologies advance, analytical capabilities at Central Labs will continue to expand. “We’ve designed a new approach towards immune monitoring called ‘backbone panels’ to represent the different arms of the immune system,” says Dr. Peretz. “Our clients can view the open positions on the panel to make informed decisions about their study and include their biomarkers of interest.”
Standardizing data analysis with data automation tools is a priority. “As the complexity of the instrument increases, so will the amount of data required to be analyzed,” says Hedin. “We’re now investigating automated algorithms for data analysis.”
Partnering with Labcorp Central Labs
No matter where the study is being performed, our global scale of operations across each of the five locations provides ‘centrality’ to samples. Backed by expert technical staff, our flow cytometry service employs a suite of modern instruments meticulously selected and evaluated by our experts to serve global clinical programs