The Gyros is an automated immunoassay platform using a CD spinning disk technology, microfluidics, and a laser-based fluorescence
detection system to quantitate monoclonal antibodies, drugs, proteins, and biomarkers from nanoliters of biological fluids.
The immunoassay can be developed and be ready for sample analysis in three to five days, compared with other platforms that
require weeks (see Case History). Instead of a well or a bead, the Gyros uses nanoliter columns packed with streptavidin beads
positioned at the periphery of a plastic disk that is subsequently spun. Each column has a microfluidics channel system etched
in the disk to carry reagents and buffers for washing steps. As the disk spins, centrifugal force moves the reagents at the
appropriate time over the columns.
CHOOSING AN IMMUNOASSAY PLATFORM IN A TIME-CRITICAL ENVIRONMENT
When tasked with choosing the best platform and completing immunoassay development and core validation in less than two weeks,
scientists must identify, purchase, and test commercial reagents for the assay. Each immunoassay that is run on the Gyros
takes 70 minutes, compared with other technologies which require four hours or more, and in some cases overnight incubation
while the reagents bind in each step. Scientists using Gyros can complete a number of experiments in a single day and then
have a method ready in less than three days.
The sample volume for the Gyros is very low, requiring as little as six microliters, while other technologies may require
as much as 100 microliters per sample. Because of the wide dynamic range of the Gyros assay, sample repeat runs are greatly
reduced when compared with a traditional ELISA. Fewer sample repeat runs means greater overall efficiency.
The Luminex can run many ELISAs simultaneously (multiplex) to search for biomarkers, whereas the Gyros does not offer multiplexing
capabilities. The MSD is a versatile platform commonly used for measuring antidrug-antibodies (ADAs) and MSD offers a number
of multiplexing assay kits. Due to long assay run times, however, it takes two or more weeks to build a customized immunoassay
on the MSD.
While commercial Gyros kits are not widely available, CROs and biopharmaceutical companies with Gyros technology custom develop
assays to boost time-critical workflows, thereby meeting increasing regulatory demands on testing. For small, medium-sized,
and virtual sponsor companies especially, outsourcing immunoassays to a Gyros-equipped CRO has clear advantages—fast development
times, cost-savings from reduced timelines, along with no requirement for capital investment. The CRO can then perform unattended
analyses at nanoliter scale, saving labor and reducing costs while conserving sample and reagents.
Mark J. Cameron is senior manager of biomarkers and immunoassay, MPI Research, 54943 North Main Street, Mattawan, MI, 49071.