What is in the UltraSEEK® EGFR Liquid Biopsy Panel?

The UltraSEEK® EGFR Panel is a research-use-only assay designed to detect six high-impact EGFR variants from circulating free DNA (cfDNA) samples. Developed for non-small cell lung cancer (NSCLC) studies, this panel enables researchers to carry out sensitive mutation profiling in samples that often fall below traditional testing thresholds. With just 10 ng of cfDNA, laboratories can assess key variants such as T790M, C797S, E746_A750del, and L858R, even in the presence of low tumor fractions.

This panel minimizes the need for invasive tissue biopsies and supports longitudinal sample collection in translational research and clinical trials, all while reducing time, cost, and sample rejection rates.

Role of EGFR Mutations in Non-Small Cell Lung Cancer

EGFR mutations are among the most common driver alterations in NSCLC and play a critical role in determining response to tyrosine kinase inhibitors (TKIs). Activating mutations such as L858R and E746_A750del are known to confer initial sensitivity to EGFR-targeted therapies. However, resistance mutations—including T790M and C797S—often emerge after treatment, limiting clinical efficacy.

Monitoring EGFR-positive patients over time using liquid biopsy allows clinicians to track clonal evolution and adjust therapeutic strategies accordingly. Detecting these mutations accurately and with minimal input DNA is essential for reliable data, particularly in research focused on resistance mechanisms and treatment sequencing.

About the UltraSEEK® EGFR Panel

The UltraSEEK EGFR Panel offers a highly sensitive, multiplexed assay for detecting clinically relevant EGFR mutations in cfDNA. Leveraging Agena’s proprietary mass spectrometry-based technology, the panel detects low-frequency mutations with high specificity—even in challenging, low-yield samples that are often rejected by NGS platforms.

Mutation coverage includes:

• p.E746_A750del (c.2235_2249del & c.2236_2250del)

• p.L858R (c.2573T>G)

• p.T790M (c.2369C>T)

• p.C797S (c.2390G>C & c.2389T>A)

The panel’s simple workflow, short hands-on time (~1 hour), and fast turnaround (8 hours total) make it suitable for research labs that require both sensitivity and speed in NSCLC studies.

Principle and Workflow

The UltraSEEK EGFR Panel uses multiplex PCR followed by single-base extension and detection via mass spectrometry. This technology enables discrimination between wild-type and mutant alleles in samples with low variant allele frequency. The workflow is optimized for minimal manual steps, making it both efficient and reproducible.

Workflow overview:

1. cfDNA extraction from plasma or serum

2. PCR amplification of target EGFR regions

3. Single base extension using UltraSEEK reagents

4. Detection via mass spectrometry

5. Variant reporting through automated software

This robust and cost-effective approach supports consistent mutation detection across diverse cfDNA samples, reducing failure rates compared to sequencing-based methods.

Clinical Application in Research Settings

While the UltraSEEK EGFR Panel is for research use only, its applications are highly aligned with translational and clinical research goals. In NSCLC, EGFR-targeted therapies rely on precise mutation information for both treatment initiation and monitoring resistance. Tissue biopsies, however, are not always feasible or representative of current tumor dynamics.

With the UltraSEEK Panel, researchers can perform longitudinal analysis of EGFR mutations via liquid biopsy, enabling real-time monitoring of disease evolution. This is especially useful in multi-center studies and for patient cohorts with limited tissue access.

In addition, this assay’s ability to work with low tumor content and degraded DNA significantly increases sample inclusion, enhancing data completeness and study reliability.