August 2025—Precision Epigenomics presented validation data for its flagship multicancer early detection (MCED) test, Episeek, at the 2025 ASCO annual meeting in Chicago, May 30–June 3. The data demonstrated that the blood-based test is capable of identifying more than 60 cancer types with a 99.5 percent specificity rate and a turnaround time of two to three days. The test was validated on 281 cancer-positive plasma samples across all four stages and 201 samples from healthy people over 40 years old. It showed a 45 percent sensitivity for stage I/II cancers and a 74 percent sensitivity for stage IV cancers, with positive and negative predictive values of 64.9 percent and 99.5 percent, respectively.
Episeek uses quantitative polymerase chain reaction to detect hypermethylated DNA regions that are specific to malignancy, allowing it to avoid the high cost and complexity of sequencing-based methods. “This test represents a shift toward accessible, scalable cancer diagnostics,” Mark Nelson, PhD, CEO of Precision Epigenomics, said in a press statement. “We designed Episeek to reach the communities traditional screening has left behind.”
Speaking at ASCO, senior scientist and study lead Thi Hanh Pham, PhD, noted the need for tools that target aggressive, fast-moving cancers. “Many lethal cancers are detected too late because there are no effective screening options today. Episeek aims to change that by detecting the signals at stage I or II, when treatment is more likely to succeed.”
The company also emphasized its platform’s analytical performance, highlighting a limit of detection under 0.1 ng of cell-free DNA for eight out of 10 biomarkers. The test is offered out of the company’s CLIA-certified laboratory in Tucson, Ariz.
In addition to its validation study, Precision Epigenomics modeled the public health impact of Episeek in a simulated 100,000-patient cohort using 2024 SEER (Surveillance, Epidemiology, and End Results program) incidence data. The analysis indicated strong detection capability for cancers responsible for the majority of cancer-related mortality, including lung, liver, pancreas, brain, and esophageal cancers.
Precision Epigenomics COO Richard Bernert, MD, noted that the market for liquid biopsies has expanded dramatically. “This is the breakthrough we’ve been waiting for,” he said. “We believe that Episeek can be deployed worldwide as a front-line screening tool.”
Joshua Routh, MD, medical director of Precision Epigenomics, said the company is exploring additional applications of its technology. “We are preparing to launch a pleural effusion malignancy test and will present additional data at the AMP annual meeting later this year.”
The technology behind Episeek was developed at the University of Arizona and further enhanced through grants from the National Institutes of Health. Precision Epigenomics has integrated proprietary probes and machine learning algorithms into the platform, delivering a cost-effective solution that can be adopted across public and private health care systems.
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