28 Aug AACC Thoughts – Determining the Level of Automation for your Diagnostic Assay
We met with a wide variety of new and existing customers at AACC earlier this month. Everyone is eager to get to market of course, but a key question most are asking as they gear up to launch their assays is: what should the human do versus what should a robot automate?
We typically see three main paths for assay automation. Some assays are purely sample preparation, while others facilitate prep and detection. Each one requires a unique engagement to define the optimal architecture, then develop the product for commercialization.
- User-centric, with minimal to no automation
- Automation with mostly off-the-shelf components, but with a custom enclosure
- Full assay automation with custom components
User-centric, with minimal to no automation
These customers are typically developing a sample prep assay where the human completes all the sample handling and preparation steps prior to downstream detection on an existing platform. For rapid diagnostic tests or Point of Care Diagnostics, CLIA-waivers are being pursued, meaning that an untrained user should be able to facilitate the sample prep assay with minimal training. Sample prep kits in this scenario are purely mechanical and require clever fluidics and user-facing design to ensure appropriate mixing ratios needed to prep the sample. With these customers, we try to explore solutions obviously on the device side, but at Key Tech we stress the value that packaging can bring to user experiences to facilitate sample prep steps. Perhaps assay consumables can be cleverly integrated into the packaging, such that just by pulling consumables out of the package, a few assay steps are completed automatically. The key is reducing the number of user steps to decrease the likelihood of user error. For these customers we initially propose rapid innovation engagements to explore assay automation steps via mechanical manipulation with use testing to vet out potential product architectures.
Automation with mostly off-the-shelf components, but with a custom enclosure
These assay customers have multiple, complex sample handling steps that need a liquid handling system, or the assay has enough custom features to warrant development of a customized automated box. Many of the folks we talk with at shows like AACC are experienced in the diagnostic industry and they know they can sell their custom assay/diagnostic technology in the market. With the minimal amount of investment possible, they look to Key Tech to develop a diagnostic system that leverages off-the-shelf components, while limiting the amount of custom component design that may extend development timelines. Further, their product needs a brand image, so they need a custom box with a nice aesthetic.
The Key Tech team knows that the footprint must be small, and where to find the off-the-shelf electronics and existing sub-circuitry from prior projects that will apply to their application. We leverage our custom software package, Key# to get electronics and GUI’s up and running quickly so that early prototypes can be put in the hands of assay scientists for testing. Ultimately these customers are looking to get the product out the door as fast as possible, so we propose early engagements that include scrappy testing to explore the optimal system architecture, while in parallel developing early industrial design concepts for the system.
Full assay automation with custom components
Sample in, results out. These customers have premium assays that are very challenging to automate, requiring custom components. An example is GenMark’s ePlex, developed in partnership with Key Tech. Key Tech applies a de-risking, scientific method approach to challenging assay automation projects to determine the optimal architecture of their very complex diagnostic system. This could be a POCT diagnostic developed around a complex cartridge and instrument. It is a complex assay that requires many automated steps and is worth the investment in a custom diagnostic cartridge or a more complex instrument, because of the premium provided in sensitivity and specificity, or perhaps the broad assay menu the system can support. For these customers, we follow Key Tech’s De-Risking Approach to characterize the assay, study the governing variables of interest, then define the optimal architecture. Below is an image of this approach:
Following another successful AACC trip, it is clear that our customers understand their assays very well. It’s up to us here at Key Tech to help them balance the investment required to automate their assay in the various ways described above, with the market size and window available for their products. Reach out to us for more information.
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