No commercially available CTC detection system performance compares to BioFluidica's. Thanks to its flexibility, it can be readily adapted for a variety of applications. The BioFluidica system is ideal for those applications where the ability to conduct frequent tests inexpensively, and deliver results quickly for point-of-care testing, are critical.
With its highly parallel design, BioFluidica's system can be tailored to quickly process the large input volumes needed to enumerate target cells with a high statistical confidence. It can process either 1ml or 10 mL of blood in less than 30 minutes. No other cartridge device comes close. BioFluidica also offers a simple workflow. No centrifuging, staining, or other sample preparation is required prior to the cartridge assay, reducing potential loss of rare CTCs or contamination. There is no need for operator intervention once the test has begun. Sample point-of-care testing eliminates the extensive turnaround time required for central laboratory testing and test results reporting. With the BioFluidica system the time from patient blood sampling to final results can be on the order of an hour instead of days.
BioFluidica's technology incorporates several critical design factors, shear force, channel width, nanostructuring, immuno- and aptamper-based selection, and conductivity-based enumeration, each contribute to high recovery and high purity of the CTCs. The recovery and purity for BioFluidica's technology is unprecedented, reaching over 95% and 80%, respectively.
Sample integrity is another accuracy factor, reinforced by the system's closed architecture. There is no sample transfer from instrument to instrument, minimizing contamination, while the use of disposable cartridges eliminates sample cross contamination.
Finally, the method used for enumeration, electrical conductivity, is both highly sensitive and efficient. It can be used to count 1 to 25,000 cells with minimal false positives. As an added advantage, enumerated un-labeled cells remain intact, making them available for molecular analysis and culturing.
BioFluidica significantly reduces the cost per assay compared to commercially available systems, by employing low-cost, injection molded polymer cartridges. We rely on commercially available components for our instrumentation, sample processing and analysis. We have integrated and automated the process, eliminating the need for highly specialized technicians. Point-of-care testing eliminates the cost of overnight sample shipments to a central reference laboratory.
With all of the processing steps integrated onto a single polymer cartridge, BioFluidica's CTC analysis requires no laboratory-based sample preparation. The instrument can be placed in a small housing, approximately a cubic foot in size. As a result, our CTC testing system is lightweight and highly portable, making point-of-care testing possible for the first time. The combination of light weight, small form factor, totally integrated and automated operation, standard blood sample requirement and easy readout makes our technology ideal for remote and third-world locations as well as smaller clinics and hospitals in developed countries.
Cells in the BioFluidica process retain their full integrity and biological function after capture and enumeration, and are available for further processing. This allows the BioFluidica system to be integrated with molecular, or other, analysis of the CTCs.