QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of three new kits for use on its QIAcuity systems and a major new software update designed to expand the portfolio of applications for use of digital PCR technology in areas like cell and gene therapies, DNA and RNA quantification, as well as food and pharmaceuticals safety:

  • The QIAcuity Mycoplasma Quant Kit offers researchers an accurate and precise way to detect mycoplasma contaminants in all steps of research and manufacturing of cell and gene therapies. The kit offers a unique and sensitive workflow that has been validated by a third party and complies with the mycoplasma testing frameworks provided by the US, the EU and the Japanese Pharmacopeia, thus reducing validation effort in-house.
  • The QIAcuity OneStep Advanced EG Kit allows researchers the highly sensitive quantification of RNA or RNA alongside DNA in one reaction. The kit uses intercalating dye technology that makes procedures easier to design and more cost-efficient than those used in fluorescent-probe-based PCR. In contrast to other chemistry, the patent-pending HotStart RT enzyme is only active at higher temperatures, preventing uncontrolled reaction activity while plates are set up in the lab or waiting for cycling in the QIAcuity instrument. This allows reaction set-up at room temperature and leads to more reliable results in multi-plate workflows. QIAGEN’s OneStep and other innovative chemistry ensures a fast and easy workflow, with little hands-on time.
  • QIAcuity mericon Food Testing Kits are the only ready-to-use digital PCR food tests on the market. They enable researchers to fight product adulteration through target-specific authentication of food and animal-feed ingredients. The launch sees QIAGEN extending its large food-safety testing portfolio from traditional quantitative PCR, providing increased precision and sensitivity, as well as ensuring dependable data analysis and interpretation.

“The launch of our new QIAcuity kits and the software update emphasize QIAGEN’s dedication to advancing digital PCR analysis in crucial sectors like pharma, biopharma research, and food and drug safety,” said Nitin Sood, Senior Vice President and Head of the Life Sciences Business Area at QIAGEN. “By incorporating these innovations into our QIAcuity platform, we are reinforcing our commitment to providing precise, fast, scalable and easy-to-use digital PCR solutions for a wide range of applications.”

Additionally, QIAGEN plans to launch in November the QIAcuity Software 2.5 update. It is designed to help researchers determine two key features of digital PCR analyses. Using the functionality of a temperature gradient, the software will allow them to determine the precise temperature at which their experiment should run, saving the need to put the sample through an external thermocycler during the development of tests to target specific genetic building blocks.

As sample material is often diluted before being analyzed by digital PCR, the new software will also calculate the prevalence of the targeted material in a sample and any dilution required. After the test, QIAcuity Software 2.5 adjusts for dilution and converts the results into user-defined units, automating and documenting a demanding task crucial for pharmaceutical companies’ reports and audit trails.

QIAGEN’s digital PCR platform QIAcuity uses nanoplates to disperse a sample over thousands of tiny partitions and then read the reaction in each one simultaneously to quantify even the faintest signals from DNA and RNA. The instruments integrate partitioning, thermocycling, and imaging into one workflow, cutting processing times to only two hours from six.

The highly versatile QIAcuity systems are available in one, four, and eight-plate versions, with the one-plate version processing up to 384 samples in an eight-hour shift and the eight-plate version up to 1,248 in the same time period.