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Serum Laboratory Studies, Stool Test, Breath Test01:30

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Gastrointestinal (GI) diagnostic studies are pivotal in confirming, ruling out, diagnosing, or staging various diseases, including cancers. Following diagnosis, allocating time for discussions with the patient and providing informational resources is crucial. Diagnostic assessments of the GI tract often occur in outpatient settings like endoscopy suites or GI labs. Preparation for these tests may include dietary restrictions, fasting, liquid bowel preparations, laxatives, enemas, and the...
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Correction: Held et al. A Protein-Based Blood Test for Multi-Cancer Diagnostics. <i>Biomedicines</i> 2025, <i>13</i>, 2510.

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A Protein-Based Blood Test for Multi-Cancer Diagnostics.

Douglas Held1, Steven Bolland1,2, Robert Freese1

  • 1Traxxsson, LLC, Saint Louis, MO 63021, USA.

Biomedicines
|October 29, 2025
PubMed
Summary

A novel protein-based multi-cancer early detection (MCED) test shows 100% sensitivity for five cancers, including Stage I, with high specificity and tissue-of-origin accuracy. This blood test could improve cancer screening outcomes.

Keywords:
early diagnosismulti-cancer detectionprotein biomarkers

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Area of Science:

  • Biomarker discovery and validation
  • Oncology
  • Proteomics

Background:

  • Conventional cancer screening methods have limitations, including high false-positive rates and lack of options for several high-mortality cancers.
  • Existing screening modalities often involve invasive procedures and may not be widely accessible, contributing to delayed diagnoses.

Purpose of the Study:

  • To evaluate a protein-based multi-cancer early detection (MCED) test for its ability to accurately detect five high-burden cancers.
  • To assess the test's sensitivity, specificity, and tissue-of-origin (TOO) accuracy in distinguishing cancer patients from healthy individuals.

Main Methods:

  • Analysis of serum samples from 141 cancer patients (breast, lung, colorectal, ovarian, pancreatic) and 119 healthy controls.
  • Utilized a 16-parameter protein biomarker panel measuring extracellular protein kinase A (xPKA) activity, other kinase activities, and cancer-associated antibodies (IgG, IgM).
  • Developed a supervised, rule-based classification framework for cancer detection and TOO assignment.

Main Results:

  • Achieved 100% sensitivity across all five tested cancer types and 97% overall specificity.
  • Demonstrated 98% accuracy in identifying the tissue of origin (TOO) for detected cancers.
  • Successfully detected 100% of Stage I cancers, with specificities ranging from 96.6% (breast) to 100% (ovarian, pancreatic, colorectal).

Conclusions:

  • The protein-based MCED test exhibits high performance in detecting multiple cancers and their origins.
  • The assay shows significant promise for early-stage cancer detection, including 100% sensitivity for Stage I.
  • This approach may offer a less burdensome alternative to current diagnostic pathways, potentially improving patient outcomes.