As the third generation of PCR technology, digital PCR introduced powerful new capabilities to countless research applications. Features such as improved precision and sensitivity, absolute quantification of nucleic acids, and tolerance to common PCR inhibitors set digital PCR apart, but the introduction of Droplet Digital™ PCR (ddPCR™) technology pushed the field even further. For over a decade, ddPCR technology has proven itself as an industry-leading digital PCR format offering unparalleled performance for researchers worldwide.
But the power and utility of Bio-Rad’s ddPCR offerings lie far beyond the instruments. The quality of digital PCR data can only be as high as the assays used to obtain it. High-quality assays ensure that the results are accurate and consistent, minimizing the risk of false positives or negatives. This is essential, especially in experiments assessing low-abundance targets, rare mutations, or minimal sample inputs. Bio-Rad’s comprehensive catalog of high-quality, validated ddPCR assays and kits for diverse applications from cell and gene therapy quality monitoring to gene expression research, makes it simpler for researchers in any field to use digital PCR confidently.
For example, a growing number of oncology researchers are leveraging ddPCR technology to develop minimally invasive biomarker analysis methods for monitoring treatment, detecting relapse, and more. Because circulating tumor DNA (ctDNA) and other blood-based biomarkers are often present at extremely low levels, highly sensitive and specific assays are essential to achieving trustworthy results. Droplet Digital PCR technology can detect mutant DNA at concentrations as low as 0.1% in a single well. Bio-Rad offers wet lab-validated assays for over 200 mutation targets, as well as a variety of multiplex mutation detection kits for screening of multiple cancer mutations in a single well, empowering clinical researchers in advancing liquid biopsy and other oncology applications.
Even with a vast catalog of available assays, the dynamic nature of research means that many users need custom options to support their experiments. Whether a researcher knows their sequences of interest or needs expert guidance in designing a ddPCR assay, Bio-Rad supports users with custom assays produced under stringent manufacturing conditions and are ready to use. By using high-quality assays made specifically for the platform, researchers can ensure they harness the full potential of ddPCR technology.
Bio-Rad’s Droplet Digital PCR assay and kit offerings also support users for whom the precision and sensitivity of their method can have significant regulatory implications. Many cell and gene therapy developers are turning to ddPCR technology for quality and contamination testing, where stakes are high for patient safety and development timelines. Bio-Rad’s family of Vericheck ddPCR kits was developed to address this need. Kits are available for safety and contaminant testing at every step of the cell and gene therapy development and manufacturing workflow, including residual DNA quantification for HEK293, CHO, and E. coli cell lines, determination of empty-full capsid ratios for AAV vectors, detection of replication-competent viruses, and more.
According to Dipika Gurnani, Product Manager at Bio-Rad, these kits represent an effort to improve cell and gene therapy development as a whole. “Our goal is to offer standardized kits that can be used universally, and their results compared across labs,” Gurnani says. “We are dedicated to making these kits accessible on a common platform to deliver additional value for our customers. A standardized kit would also allow regulatory agencies to trust the consistency and reliability of the results obtained.”
Digital PCR has undeniably transformed the power and versatility of nucleic acid quantification in countless research applications, but not all digital PCR platforms are created equal. Using high-quality instrumentation and specific, validated assays is vital to obtaining trustworthy results. Bio-Rad has risen to meet this need, pioneering Droplet Digital PCR technology and offering a vast portfolio of assays and kits encompassing the full spectrum of digital PCR applications. By connecting users across life sciences, public health, and beyond with reliable and high-quality ddPCR assays, their catalog and custom offerings help set researchers up for success to make innovative and impactful work possible.
