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Updated: Apr 5, 2026

Single Droplet Digital Polymerase Chain Reaction for Comprehensive and Simultaneous Detection of Mutations in Hotspot Regions
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Profiling KRAS mutations in whole blood by error-corrected maximum depth sequencing.

Ryne C Ramaker1,2, Yuchen Zhang1, John H Strickler2

  • 1Department of Pharmacology & Cancer Biology, Duke University, Durham, NC, USA.

NPJ Precision Oncology
|April 3, 2026
PubMed
Summary
This summary is machine-generated.

A new K-MDS blood test accurately detects KRAS mutations, even at low levels. This sensitive assay shows promise for cancer monitoring and predicting recurrence risk in patients with solid tumors.

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Area of Science:

  • Oncology
  • Genetics
  • Molecular Biology

Background:

  • Clinical application of circulating tumor DNA (ctDNA) sequencing is growing.
  • Current ctDNA sequencing faces limitations in sensitivity and requires specialized sample collection.

Purpose of the Study:

  • To adapt Maximum Depth Sequencing (K-MDS) for whole blood to detect oncogenic KRAS mutations.
  • To evaluate the sensitivity and specificity of K-MDS for KRAS mutation detection in cancer patients.

Main Methods:

  • Developed K-MDS for whole blood to sequence the KRAS oncogene with error correction.
  • Tested K-MDS sensitivity using spiked cancer cells in healthy blood.
  • Validated K-MDS against commercial ctDNA tests in 190 advanced cancer patients.
  • Analyzed K-MDS performance in preoperative samples from 18 pancreatic cancer patients.

Main Results:

  • K-MDS detected KRAS mutations at 0.001% dilution with 100% specificity.
  • K-MDS identified commercially-identified KRAS mutations in 88% of advanced cancer patients.
  • K-MDS uniquely detected mutations in patients treated with EGFR/KRAS inhibitors and showed higher sensitivity in bone metastasis cases.
  • K-MDS stratified pancreatic cancer patients by recurrence risk based on preoperative blood samples.

Conclusions:

  • K-MDS offers a sensitive and specific method for targeted oncogenic KRAS mutation detection in whole blood.
  • The assay has potential utility in low ctDNA burden scenarios and for predicting metastatic disease recurrence.
  • K-MDS may complement existing ctDNA assays for comprehensive cancer mutation profiling.