What’s new
- Collection change: Unlike traditional FIT or mt-sDNA tests that require patients to swab stool at home, this mt-sRNA test lets patients mail a full sample with no scraping. Trained lab staff then perform the FIT (“in-lab FIT”) on arrival.
- Why it matters: Removing at-home swabbing aims to boost adherence and reduce pre-analytical variability (user error, uneven sampling), two known pain points in stool-based screening.
Study design (analytical + clinical equivalency)
- Setting: Central lab evaluation of the in-lab FIT component within the FDA-approved mt-sRNA assay (ColoSense).
- Specimens: Pooled stools with known hemoglobin (Hb) levels; separate prospective healthy cohort for equivalency; retrospective CRC/advanced adenoma (AA) samples.
- Analytical challenges tested:
Freeze–thaw stability; common dietary interferents; stool input volume (50–250 g); precision across lots/users/days/instruments; in-transit stability (ambient, up to 120 h).
Clinical equivalency (in-lab FIT vs at-home FIT)
- Prospective healthy cohort (n=70): 94% concordance; PPV 100% (7/7); NPV 94% (59/63).
- Retrospective disease samples: CRC sensitivity 77% (27/35); AA sensitivity 33% (2/6)—consistent with reported at-home FIT performance (~78% CRC; ~29% AA).
Interpretation
- The in-lab FIT is analytically robust across real-world stressors (shipping delays, diet, varied stool mass, freeze–thaw) and clinically equivalent to at-home FIT for classifying samples.
- Because patients no longer swab, this approach can lower barriers to screening and reduce user-driven variability, potentially improving program adherence and population-level early detection—especially as stool molecular tests gain adoption.