cfDNA · Methylation · Machine Learning · MASLD
Tensor Bio applies cell-free DNA methylation profiling and AI to deliver accurate, non-invasive fibrosis staging — from a single blood draw.
The Problem
With two FDA-approved therapies now on market — Rezdiffra and Wegovy — clinicians urgently need to identify eligible patients. The tools to do that don't exist at scale.
Invasive, costly, real procedural risk. Refusal rates run 40–60%.
Operator-dependent, equipment-limited, unavailable in most primary care.
30–40% of patients land in an indeterminate zone — no actionable answer.
No test exists that can reliably stage fibrosis and replace biopsy.
FDA-approved March 2024. Requires confirmed F2–F3 fibrosis for prescription eligibility — creating an immediate bottleneck at staging.
FDA-approved August 2025 for MASH. Staging and serial monitoring required for therapy response assessment in patients with metabolic dysfunction.
Fewer than 5% of eligible MASH patients have received a formal fibrosis assessment — a gap that widens as every new approved therapy requires a staging decision.
A reliable, accessible, blood-based fibrosis staging test solves a clinical problem that is growing by the day and has no credible existing solution.
Our Approach
A liver cell-type specific epigenetic signal that protein biomarkers cannot replicate — trained on gold-standard biopsy-matched clinical data.
cfDNA methylation captures liver cell-type specific epigenetic information shed into blood — a signal purpose-built for clinical staging and serial monitoring of fibrosis progression.
ML and deep learning trained on biopsy-matched MASLD clinical samples. Interpretable signal output calibrated for the F0–F1 vs F2–F4 binary classification that drives MASH treatment decisions.
Designed from the ground up for staging, serial monitoring, and screening across the full MASH disease arc — MASH Select™ spans the complete diagnostic lifecycle from FIB-4 indeterminate to on-therapy monitoring.
Market Opportunity
38% of US adults carry a diagnosis that puts them on the path toward liver fibrosis. Of these, 19.8M have progressed to MASH — the inflamed, fibrosis-driving form that requires accurate staging.
Staging ($9B), serial monitoring ($12.75B), and PCP screening ($8.75B) represent a combined TAM driven by an expanding portfolio of approved therapies requiring confirmed diagnostic access.
Rezdiffra (March 2024) and Wegovy (August 2025) both require confirmed fibrosis staging before or during treatment — creating an immediate, unfilled clinical bottleneck that MASH Select™ is built to address.
Let's Talk
We are selectively engaging with clinical partners and scientific collaborators.
If you are building a MASH clinical program, interested in a clinical collaboration, or are a hepatologist or KOL open to scientific dialogue — we welcome a conversation.
We are actively engaged with biopharma partners building MASH clinical programs, hepatologists and KOLs interested in scientific collaboration, and academic groups working in cfDNA biology or metabolic disease.
We'll be in touch within 48 hours. Thank you for your interest in Tensor Bio.