The following interview was conducted with Promega and discussed the democratization of laboratory instrumentation and some of their new developments on the horizon.
Q1. What are some of the areas in which you are actively developing products? Where is there the greatest need?
The scientific segments we serve include academia, government, pharma, biotech, clinical diagnostics, applied and enviro testing and genetic identity. Our core technologies are sample preparation solutions, sample analysis solutions, protein analysis and molecular cloning, cellular reporting and signaling, cell health and functional analysis and segment services (for example custom and OEM manufacturing, custom assays, platform integration, application development).
We see significant demand coming from clinical and molecular diagnostics, particularly in light of the global pandemic. Promega solutions supported COVID-19 diagnosis in over 25 million samples around the globe in the first quarter of 2020 alone and our work in this field continues to grow.
We also see strong growth coming from the applied markets, particularly environmental and food testing. In Europe, Promega DNA purification reagents have become a reference standard in authenticity determination of meat products, and European Union Reference Laboratory for Animal Proteins in feeding stuffs (EURL) has developed a Standard Operating Procedure for DNA extraction based on our purification chemistry.
Q2. Tell me more about the Spectrum Compact CE System. What advantages does the Spectrum Compact CE System provide in the laboratory?
Capillary electrophoresis (CE) instruments are often too big or expensive for labs that only need to process a handful of samples. The Spectrum Compact CE system fits on the benchtop and easily fits into workflows with flexible run scheduling, an easy-to-use interface, separate plug-and-play consumables and small batch sizes. This integrated and efficient instrument enables Sanger sequencing and fragment analysis on the benchtop, on-demand.
One of the huge advantages of this instrument is that it is personal. An individual can walk into the laboratory and with minimal training can change all the consumables, perform DNA sequencing and fragment analysis experiments and select which chemistries they want to use, whether it is Promega chemistries or a competitor’s chemistries, for DNA sequencing, as well as for fragment analysis, and perform the experiment. It requires minimal training once the instrument is set up and everyone has access – it democratizes the use of the instrument in the laboratory.
The Spectrum Compact CE System is an automated, 4-capillary electrophoresis instrument that processes up to 32 samples in a single run. It’s compatible with existing Sanger sequencing chemistries and 4-, 5- and 6-dye STR kits.
We have talked to several customers who have been looking forward to this instrument and they are really excited about having a full-size CE device at their bench, meaning they no longer need to rely on core facilities. On-site installation and operational training are included with the purchase of the instrument, and Promega scientists are available to help with validation, applications training and preventive maintenance.
Q3. Which applications does the Spectrum Compact CE System support?
The Spectrum Compact is the solution for academic, clinical research and forensic laboratories looking to take analyses into their own hands. The instrument supports applications such as microsatellite instability analysis, mixed sample analysis and forensic STR analysis.
Another key application is cell line authentication. This is expected for grant applications submitted to the NIH and required for publication in many scientific journals. STR analysis is a simple, definitive process used for authenticating cell lines that assures researchers about the integrity and reproducibility of their data. The Spectrum Compact CE System, paired with STR-based GenePrint® System for human cell line authentication, provides in-lab cell line authentication. The low to medium-throughput instrument can batch process and minimize reagent waste to accommodate individual labs or small lab clusters. And the sensitivity achieved with the Spectrum Compact CE System can help identify cell line cross-contamination before starting experiments.
Q4. What can you tell me about Sanger sequencing and fragment analysis? Where are these kinds of analysis needed, and what are the conventional methods? What was the footprint of the relevant equipment, and has this traditionally required a dedicated unit or outsourced sequencers?
Genetic analysis methods have become essential in many labs. Short tandem repeat (STR) analysis, for example, was most often used in forensic and paternity analyses. However, STR analysis can also support non-forensic applications such as cell line authentication and mixed-sample genotyping. Researchers are turning to these methods to verify cell line origins, detect sample contamination and track genetic changes. Similarly, Sanger sequencing by capillary electrophoresis is the gold standard for DNA sequencing, even with the advent of next-generation sequencing (NGS). The current best practice in many labs is to confirm NGS results with Sanger sequencing, and Sanger is the most cost-efficient method for sequencing single samples.
Q5. What were the main drivers behind the design and development of the Spectrum Compact CE?
We now have the opportunity to provide a complete solution to labs, enabling them access to an instrument for DNA separation and analysis, improving their chances of success. Many of our customers have been asking for a single base resolution capillary electrophoresis instrument from Promega since we provide high-quality reagents for these applications.
On the design side, we were looking for an affordable instrument that performs both Fragment Analysis and Sequencing with high quality. A CE instrument that is easy to learn and use, and that is flexible to adapt to any user's workflow, including the ability to set up protocols and view data remotely. The instrument had to be highly reliable with no interruptions to operation and ideally would have a small footprint with no special infrastructure required in a customer's lab. We wanted related consumables that are easy to use and change out when depleted.
The Spectrum Compact CE System is low throughput by design. We have heard from many scientists who do not process enough samples to justify purchasing a higher-throughput instrument, so this instrument was engineered to meet those specific needs.
Q6. How might “democratizing laboratory instrument use” change working practices? How would you characterize the impact that the device could have on a typical laboratory?
Any scientist in the lab, regardless of skill level or expertise, can use the Spectrum Compact CE System with minimal training due to the intuitive user interface. The Spectrum Compact CE System allows labs to get results on their own timeline without waiting to batch samples or send samples to an outside lab. This makes it easier for labs to keep these applications in-house, which will reduce cost-per-sample in the long run and help laboratories avoid delays and scheduling headaches.
In the past, many labs have relied on sending samples to core labs for analysis. This caused problems for several reasons. Limited or rare samples had to be packaged and sent out of the lab, results could take any amount of time, and researchers had little or no control over the workflow. Our instrument eliminates the need to depend on core labs and allows labs to keep these applications in-house. This will reduce cost-per-sample and help labs control their own timelines.
The Spectrum Compact CE processes up to 32 samples in a single run and can be controlled by either the integrated touchscreen or by additional software that allows access from any registered computer on the same network. Guided software brings capillary electrophoresis capabilities to the hands of any scientist in the laboratory regardless of skill level.
Q7. What made this development collaboration successful and what were the most prominent lessons learned?
From a business standpoint, ensuring that each company can be successful with these efforts; it was important for the relationship to be a win-win for both Promega and Hitachi High-Tech. With any collaboration, building a good relationship is an important first step, and our face-to-face meetings went a long way to building that relationship. Understanding and sharing the needs of global customers, and how those needs differed in unique ways, was important towards developing a product for the global market. Given our different areas of technical expertise, we both learned a lot from each other throughout the process. We have developed a deep respect for each other’s knowledge, experience and capabilities. On top of that, collaborating with Hitachi helped us to grow our understanding of global customer needs and how those needs differed in unique ways.
Ultimately both companies had the same vision for the type of product to bring to market. This shared goal, along with the complementary expertise that each company provided, made for a true partnership. During the development, each team learned about the other and developed a great respect for each other's knowledge, experience, and capabilities. During development, Hitachi had a team of hardware and software engineers who routinely came to Promega headquarters to work with the Promega team of reagent experts. In turn, our service engineers traveled to the Hitachi headquarters to gain insight on supporting the instrument. We also worked closely on verification and validation efforts, as well as working through the logistics for global customer service.
Promega and Hitachi have a number of ideas for future enhancement of the Spectrum Compact, as well as other potential products.
About the Author:
Gabriela Saldanha is a Senior Product Manager in the Sample Analysis Strategic Portfolio Management Division.