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Analytical Validation of an Early Detection Pancreatic Cancer Test Using 5-Hydroxymethylation Signatures.

Shimul Chowdhury¹, Michael Kesling², Micah Collins¹

¹ClearNote Health, San Diego, California.

The Journal of Molecular Diagnostics : JMD

|September 4, 2024

Summary

The Avantect Pancreatic Cancer Test, using 5-hydroxymethylcytosine (5hmC) signatures, shows promise for early pancreatic cancer detection. Analytical validation confirms its robustness and reproducibility for clinical use.

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Area of Science:

Biomarkers
Molecular Diagnostics
Oncology

Background:

Early detection of pancreatic cancer significantly improves patient survival.
Current diagnostic tools lack sufficient effectiveness for early detection.
There is a critical unmet need for reliable pancreatic cancer screening methods.

Purpose of the Study:

To report the comprehensive analytical validation of the Avantect Pancreatic Cancer Test.
To assess the test's performance characteristics, including precision, stability, and limit of detection.
To compare the Avantect assay with an alternative method (EM-Seq).

Main Methods:

The study involved analytical validation encompassing precision, sample stability, and limit of detection.
Interfering substance studies and comparison with the enzymatic methyl sequencing (EM-Seq) method were conducted.
Assay performance was evaluated on an independent case-control patient cohort.

Main Results:

Precision studies demonstrated 100% concordance in cancer classification for biological replicates.
The Avantect assay showed stable performance for up to 7 days post-blood collection.
The test exhibited strong early-stage performance, with sensitivity for Stage I/II pancreatic cancer at 68.3% and overall specificity of 96.9%.

Conclusions:

The Avantect Pancreatic Cancer Test, based on 5-hydroxymethylcytosine (5hmC) signatures in cell-free DNA, is analytically validated.
The 5hmC approach is validated as a robust and reproducible method for pancreatic cancer detection.
The test meets requirements for laboratory-developed test accreditation, addressing a critical diagnostic gap.