Pull to refresh
Logo
Abbott launches next-generation Oncodetect test to track cancer recurrence

Abbott launches next-generation Oncodetect test to track cancer recurrence

New Capabilities

Whole-genome blood test detects cancer DNA below one part per million, tracking up to 5,000 mutations per patient

Today: Next-generation Oncodetect launches commercially

Overview

Updated 42 minutes ago

Cancer patients often finish treatment not knowing whether it worked. Abbott's new Oncodetect test, launched October 26, tries to answer that question sooner. The blood test tracks up to 5,000 mutations unique to each patient's tumor and can detect cancer DNA at concentrations below one part per million.

The sensitivity comes from MAESTRO, a technology developed at the Broad Institute that enriches tumor DNA from blood up to 1,000-fold before sequencing. That is a 30-fold improvement in detection limits over the first-generation test, which tracked only 200 variants. Abbott estimates more than 3 million US patients with solid tumors could benefit from this kind of testing.

Why it matters

If payors cover it, this test could tell patients within weeks whether treatment worked and catch recurrence months earlier.

Questions about this story

Free account needed to ask — your question is kept and asked for you right after sign-up. Answers are public.

No questions yet — be the first to ask.

Key Indicators

5,000
Patient-specific mutations tracked per tumor
Up from 200 variants in the first-generation test.
below 1 ppm
Limit of detection
A 30-fold improvement in sensitivity over the prior test version.
30 points
Absolute gain in recurrence sensitivity vs first-gen
From 42.2% to 72.2% for two-year recurrence detection in stage II-IV colorectal cancer.
3M+
US solid-tumor patients who could benefit
Abbott modeling estimate for molecular residual disease testing.

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

Sign up to generate historical perspectives on this story.

People Involved

Organizations Involved

Timeline

2023 October 2026

4 events Latest: Today
Tap a bar to jump to that date
  1. Next-generation Oncodetect launches commercially

    Today Launch

    Abbott makes the whole-genome Oncodetect test commercially available, tracking up to 5,000 patient-specific mutations.

  2. Colorectal cancer data presented at ESMO

    Research

    Beta-CORRECT study shows a 30-point absolute improvement in recurrence detection sensitivity versus the first-generation test.

  3. Abbott acquires Exact Sciences

    Acquisition

    Abbott buys Exact Sciences, bringing the Oncodetect test and its MAESTRO license into Abbott's diagnostics portfolio.

  4. Broad licenses MAESTRO to Exact Sciences

    Partnership

    The Broad Institute licenses its MAESTRO enrichment technology to Exact Sciences and begins a research collaboration for MRD test development.

Scenarios

1

Medicare and major payors establish MRD coverage

Possible Resolves by End of 2027

Discussed by: Diagnostics industry analysts tracking the liquid biopsy market

If the colorectal, breast, and esophageal data hold up in larger trials, Medicare and commercial insurers may issue coverage policies for tumor-informed MRD testing. Coverage would make the test financially viable for broad use. Without it, Oncodetect remains accessible mainly to patients who can pay out of pocket.

2

Guidelines adopt MRD monitoring as standard of care

Possible Resolves by Q2 2028

Discussed by: Oncologists and clinical trial investigators

Ongoing trials across colorectal, breast, esophageal, and other tumor types could push professional oncology guidelines to recommend routine MRD monitoring. The 30-point sensitivity gain in colorectal cancer from a single post-surgery blood draw is the kind of evidence that drives guideline changes. Abbott has more than 20 studies running to build that case.

3

Competing test keeps market lead, Oncodetect adoption lags

Unlikely Resolves by Q2 2027

Discussed by: Health economics analysts at investment banks

Natera's Signatera test has years of MRD evidence and existing payor coverage. If Abbott's reimbursement progress stalls and hospitals hesitate on a whole-genome test, Signatera could retain the market lead. The launch price and coverage decisions will determine whether Oncodetect gains ground.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2019-2021

Signatera's path to Medicare coverage (2019-2021)

Natera commercially launched Signatera, a tumor-informed molecular residual disease test, then spent two years building clinical evidence and negotiating coverage. The test detects cancer DNA in blood after treatment to estimate recurrence risk.

Then

Medicare began covering Signatera for colorectal cancer monitoring around 2021, giving the test a reimbursement foothold.

Now

Signatera became the reference point for MRD reimbursement and clinical acceptance, shaping how US payors evaluate the category.

Why this matters now

Oncodetect must clear the same evidence and coverage bar, but it arrives with whole-genome breadth and Abbott's distribution network behind it.

2013

FoundationOne and the shift to broad panels (2013)

Foundation Medicine launched FoundationOne, a broad genomic profiling panel that tested hundreds of cancer genes at once. It replaced the single-gene tests that had dominated oncology diagnostics.

Then

Broad panels became standard for advanced cancer genomic profiling, with Medicare coverage following in the years after launch.

Now

The panel established comprehensive sequencing as a clinical product, setting a precedent for whole-genome approaches in cancer care.

Why this matters now

Oncodetect's leap from 200 variants to 5,000 mirrors the earlier shift from single genes to broad panels, where more comprehensive sequencing won out on detection power.

Sources

(5)