QIAGEN announced a series of enhancements for its QIAcuity series of digital PCR (dPCR) instruments designed to drive greater use among customers, particularly those involved in the biopharma industry: New solutions are now available with ten new QIAcuity Cell and Gene Therapy (CGT) dPCR Assays for use in adeno-associated virus (AAV) titer quantification and three new QIAcuity Residual DNA Quantification Kits for checking carryover of host cell DNA. A new version of the QIAcuity Software Suite has been released with expanded functionality to support good manufacturing practice (GMP) compliance. The major expansion of QIAGEN's dPCR assay offerings comes after a milestone was achieved with more than 1,000 cumulative placements of the QIAcuity system since launch in late 2020.

QIAcuity's approach to digital PCR is based on using nanoplates to partition the samples more quickly than other systems. The instruments – available in one, four and eight-plate versions – integrate partitioning, thermocycling and imaging into one workflow, cutting processing times to only two hours from six. Biopharma customers will benefit from the launch of ten wet-lab verified QIAcuity Cell and Gene Therapy (CGT) Assays which can be designed with multiple fluorophores, and quickly produce results of superior accuracy and reproducibility, with a dynamic range of at least four orders of magnitude. The biopharmaceuticals sector is also the target group for the QIAcuity Residual DNA Quantification Kits for detecting residual host cell DNA (resDNA) of CHO, E. coli and HEK293 cells used in CGT, even when PCR contaminants and other inhibitory reagents are present in samples.

These three new kits work in conjunction with the new QIAcuity UCP Probe PCR Kit that has an ultra-clean master mix to minimize contaminating DNA background and enable residual DNA testing among other quality control applications. When paired with the updated QIAcuity Software Suite, biopharma customers can benefit from a turnkey workflow for the development and manufacturing of cell and gene therapies. Version 2.1 of the software, among other things, includes client-defined user management with customized permissions, improved plate ownership, an electronic signature for reports (to meet the FDA 21 CFR Part 11 requirement), an audit trail status indicator and robust cybersecurity.

Complementing the menu expansion is the introduction of the Expert Custom Assay Design Service, to be made available globally from the end of July, allowing dPCR users to source custom multiplex assays – for detecting various pathogens, rare mutations, copy number variations and other molecular phenomena. From design freeze to assay shipment reduced to only two weeks, customers will save time and cost. Customers will be able to access, manage and order their assays through QIAGEN's GeneGlobe Design & Analysis Hub.

On top of that, they will have access to the QIAGEN Genomic Services Team for wet-lab assay verification. Biopharmaceutical customers developing next-generation therapies are increasingly adopting dPCR to enhance drug safety and efficacy. Compared to qPCR, the dPCR technology provides a much higher level of sensitivity and accuracy that can be leveraged for multiple applications in the drug development process – from drug discovery and clinical trials to manufacturing.

The market for dPCR in biopharma is currently growing at a solid double-digit pace and becoming a multi-billion dollar market in the coming years, according to recent market research reports.