New Stilla Ruby Chip and naica® system 21 CFR Part 11 compliance enable full automation of digital PCR testing for clinically-oriented applications
BOSTON, MA (March 2, 2023) – Stilla Technologies, the multiplex digital PCR company, has recently introduced the Ruby Chip, the industry’s first ‘load-and-go’ consumable for digital PCR, optimized for its naica® system. The naica® system, which now supports 21 CFR Part 11 regulatory compliance, is part of a fully-automated sample-to-results workflow – the first of its kind for digital PCR. This platform serves the growing throughput and regulatory requirements of many clinically-oriented applications, such as in cell and gene therapy development and quality control or for liquid biopsy applications for the detection of circulating tumor DNA (ctDNA).
With adjustable throughput of up to 96 samples processing capability in under three hours, the Ruby Chip is designed with standard SBS plate spacing compatible with multichannel pipettes for manual loading and can be easily integrated with common liquid handling robots. A key feature of the Ruby Chip is that it comes ready-to-use and preloaded with sealed chambers, enabling the addition of sample mix in a single, foil-piercing pipetting step. This eliminates cross contamination and reduces handling.
“At Stilla, we seek to empower researchers with an efficient and streamlined way to load their precious biological samples for analysis, with precision and accuracy, and with minimal hands-on time,” says Remi Dangla, founder and CTO of Stilla Technologies. Notes Dangla, “As an example of our capability, we are partnering with Promega Corporation to create a fully automated solution for digital PCR analysis. This workflow will combine the naica® system with Promega’s automated sample preparation capabilities along with their Maxwell® systems for sample extraction.”
“With these new features, Stilla is responding directly to market demand for regulatory-compliant software, as well as for reduced manual handling,” says Philippe Mourere, President and CEO of Stilla Technologies. “The naica® system meets these standards, and in the context of cell and gene therapy and liquid biopsy/ctDNA quantification, end users find utility for the platform across multiple processes, be it in analytical development, sample screening/patient monitoring, or for quality assessment in the scaled-up manufacturing of a therapeutic.”
Stilla Technologies and Promega Corporation will be exhibiting at the upcoming AACR Annual Meeting 2023, being hosted in Orlando, FL. At the conference, the companies plan to present the scientific poster titled, “Automated workflow for sensitive and robust nucleic acid quantification: sample extraction and dPCR analysis utilizing the MaxPrep™ Liquid Handler, Maxwell® extraction system, and highplex assays on the naica® system” during a session on Monday, April 17.