Precision Epigenomics reports strong early-stage cancer detection data for EPISEEK

Precision Epigenomics says new validation data show its EPISEEK multi-cancer early detection test reached 58% observed sensitivity in Stage I-II cancers and 72% incidence-adjusted sensitivity across aggressive target cancers. The company says the qPCR-based blood test is available online and through physicians, positioning it as a faster and lower-cost option in a crowded MCED market.

Why it matters: - Precision Epigenomics is betting that earlier detection of hard-to-screen cancers can improve outcomes for patients facing some of the deadliest malignancies. - The company says EPISEEK could offer a faster and more affordable alternative to multi-cancer early detection tests that rely on next-generation sequencing. - Stronger sensitivity in early-stage disease is the main selling point, because screening value depends on finding cancer before symptoms and spread.

What happened: - Precision Epigenomics announced new clinical validation data for EPISEEK, its multi-cancer early detection liquid biopsy test. - The company said the findings come from an incidence-adjusted model based on 380 plasma samples across multiple cancer types and stages, using SEER incidence data. - EPISEEK is available to order online and through a physician network. - The company provided an email contact for more information: info@precision-epigenomics.com.

The details: - EPISEEK posted an incidence-adjusted estimated sensitivity of 72% across all stages for aggressive target cancers, including lung, pancreas, liver, uterus, esophagus, bladder, oropharynx and stomach cancers. - The test showed 58% observed sensitivity for all Stage I-II cancers. - Precision Epigenomics said that early-stage result is roughly 75% better than its closest competitor. - The platform detects more than 60 cancer types, according to the company. - The company highlighted strong observed sensitivity in stomach, hematologic and esophageal cancers. - EPISEEK is the only MCED test shown to detect brain cancer, with 72% sensitivity, the company said. - The company said EPISEEK delivered 72% sensitivity in brain cancer compared with 0% reported by alternative platforms in case-control studies. - EPISEEK uses qPCR technology rather than NGS or combined NGS-plus-protein approaches, which the company says supports faster and more cost-effective diagnostics. - The test has a 65% positive predictive value and 99.5% negative predictive value, based on 99.5% overall specificity. - The company said the test has a one-week turnaround time and an affordable price point. - Chief Medical Officer and COO Dr. Richard Bernert said EPISEEK’s ability to detect aggressive, highly fatal cancers and brain cancers is a major step forward. - CEO Mark Nelson said the data show the qPCR platform can improve early intervention without sacrificing precision.

Between the lines: - The headline results are framed to differentiate EPISEEK in two ways: stronger early-stage performance and detection of cancers that standard screening often misses. - The company is also trying to compete on operational simplicity, using qPCR as a lower-complexity alternative to sequencing-heavy blood tests. - The statistics are based on an incidence-adjusted model, which can be useful for comparing performance across cancer prevalence, but it is not the same as a simple raw-sample accuracy readout. - The press release includes regulatory language noting that performance and clinical utility claims have not been evaluated by the U.S. Food and Drug Administration unless otherwise stated.

What's next: - Precision Epigenomics is likely to lean on these validation data to drive physician adoption and broader commercial interest in EPISEEK. - The company also appears positioned to pursue more real-world use cases while continuing to frame the test as a screening tool that complements other clinical evaluations. - Future performance claims will need to be measured against clinical validation, regulatory scrutiny and competing MCED products in the market.

The bottom line: - Precision Epigenomics is pitching EPISEEK as a lower-cost, qPCR-based blood test with standout early-stage sensitivity in cancers that are difficult to screen for today.