TaqMan™ Oncology dPCR Multiplex Kit, ESR1

The Applied Biosystems TaqMan Oncology dPCR Multiplex Kit, ESR1, is a digital PCR (dPCR) multiplex kit designed for absolute quantification of ESR1 ligand-binding-domain (LBD) variants in oncology research. This turnkey solution comprises three multiplex dPCR assays and control material that together enable detection and quantification of nine ESR1 variants — L536H, L536P, L536R, Y537S, Y537N, Y537C, D538G, V422del, and E380Q — across exons 5, 6, and 8, with wild-type ESR1 co-amplified in every reaction and each variant assigned its own dedicated fluorescent channel.

The kit enables molecular pathology and translational researchers with enhanced capabilities for endocrine resistance research through its ease of use, fast turnaround time, and reliable results. Using the kit on the QuantStudio Absolute Q dPCR System with MAP16 plates and Absolute Q Universal DNA dPCR master mix enables results in as fast as two hours, with each variant quantified individually down to 0.1% variant allele frequency against a background of 1,000 copies/μL of wild-type reference.

Features of the TaqMan Oncology dPCR Multiplex Kit, ESR1, include:

• Individual quantification of nine ESR1 variants—each of the nine LBD variants is assigned a dedicated fluorescent dye and returns its own fractional abundance, rather than a combined signal indicating that one of a group of variants may be present. No confirmatory second reaction is required to resolve variant identity.
• Locus-matched wild-type reference in every reaction—wild-type ESR1 is co-amplified alongside the mutant targets in the same reaction, so variant allele frequency is calculated from a single well.
• Ready-to-use assay format—complete assay system delivered in a ready-to-use configuration, including controls. A streamlined, pipette-and-go workflow using MAP16 plates reduces preparation time and reduces potential for user error.
• Wet lab verified performance for high analytical sensitivity—the assays have undergone wet laboratory testing on the Absolute Q dPCR System to verify analytical performance characteristics and reliability. Each variant is quantified down to 0.1% VAF, with a limit of blank of fewer than 5 copies per well.
• Integrated quality controls—the included positive control alongside intra-reaction passive reference dye normalization helps ensure assay validity and enable quality assurance monitoring.
• False positive protection—incorporates specific design elements to limit non-specific reactions and reduce false positive results. Running on the Absolute Q dPCR System also enables other false positive protection features like AI-backed false positive rejection and sophisticated background subtraction to enable more accurate quantification.

Quantification of every variant rather than a screening call

The TaqMan Oncology dPCR Multiplex Kit, ESR1, quantifies each of its nine variants individually at 0.1% variant allele frequency, returning a fractional abundance for the specific variant present. Panel designs that pool multiple variants into a shared detection population function as screens: a positive result establishes that a variant within the group is present and identifying which one requires a separate confirmatory reaction. For research groups tracking the emergence of a specific resistance allele across serial timepoints, that additional step adds both time and sample consumption. Because every variant in this kit is resolved on its own dedicated dye, variant identity is read directly from a single channel without color-combination deconvolution or manual partition selection. Analytical performance is also uniform across the panel, so the same 0.1% threshold applies regardless of which variant a sample carries, which helps simplify method verification and operator training.

Streamlined workflow enables results in under two hours

The kit features an exceptionally straightforward workflow that mirrors the simplicity of quantitative PCR (qPCR) protocols while helping to support exceptional analytical performance. The complete process reduces hands-on time and consists of just a few essential steps to transition from sample to results. Beginning with properly extracted DNA from liquid biopsy samples, users simply prepare the dPCR reaction using the provided assay components and universal master mix, load the MAP16 plate, transfer the plate to the Absolute Q instrument, and initiate the run. All three panels share a single universal cycling program. This optimized protocol helps enable comprehensive results in less than two hours, making it highly suitable for clinical research environments where rapid turnaround times may be needed.

Gold standard TaqMan technology enhanced by advanced microfluidic arrays

The assays leverage the trusted reliability of TaqMan probe-based chemistry, which represents the gold standard for precise quantification of nucleic acid targets in molecular research with over 200,000 citations. This established detection methodology is enhanced through integration with proprietary microfluidic array plate (MAP) technology, which helps deliver consistent and accurate quantification while simultaneously reducing dead volume, simplifying workflow complexity, and accelerating time to results. This combination of verified chemistry with innovative microfluidic engineering helps provide robust performance across diverse sample types and clinical research applications.

Ultra-sensitive detection with comprehensive quality controls

The system demonstrates strong analytical sensitivity, quantifying variant allele frequencies as low as 0.1% against 9,000 copies of total input per reaction, with a limit of blank of fewer than 5 copies per well. Publishing both figures rather than a variant allele frequency alone allows a laboratory to reproduce the detection margin during its own method verification. This sensitivity makes the kit particularly valuable for minimal residual disease (measurable residual disease) research and detection of rare circulating tumor DNA (ctDNA) variants in liquid biopsy specimens. The technology is especially useful alongside next-generation sequencing (NGS) platforms for researching and monitoring the emergence of endocrine resistance variants over time.

The ready-to-use kit format includes both optimized assays and positive controls, with all components verified on the Absolute Q platform to help ensure consistent performance. Advanced software algorithms enable sophisticated false positive protection, enhancing the reliability of results and reducing the risk of erroneous interpretations in your research. This comprehensive approach to quality control and verification supports confident decision-making in precision medicine research applications.

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