Next-Generation Cancer Diagnostics

Earlier Detection.
Simpler. More Accessible.

BioncoDx is developing affordable, non-invasive liquid biopsy assays for the early detection of multiple cancers, with an initial focus on lung cancer, to reach the millions who currently lack access to effective screening methods.

Doctor and patient in clinic
Liquid Biopsy Non-invasive · Affordable · Accessible
12.8M+
Americans eligible for lung cancer screening annually[1]
~18.7%
Who actually get screened today[1]
~9%
5-year relative survival rate when detected late[2]
The Problem

Current screening fails the
people who need it most.

Low-Dose CT (LDCT) is the standard — but cost, inconvenience, and a high false positive rate mean ~80-82% of eligible patients never get screened.[1]

Too Expensive
CT scanning equipment costs hundreds of thousands of dollars, limiting availability to large urban medical centers — and scans carry a significant cost for patients, many without coverage.
Too Inconvenient
Patients must book months in advance, travel to specialized facilities, and take time off. Smokers — the highest-risk group — are often in rural areas far from screening centers.
Too Many False Positives
Nearly 25% of LDCT results are false positives — causing unnecessary anxiety and costly follow-up procedures for patients who don't have cancer.[3]
Our Solution

A simpler path to
early detection.

BioncoDx uses liquid biopsy and mass spectrometry to detect cancer-associated biomarkers — no imaging equipment, no travel, no specialist required.

Non-invasive liquid biopsy

Simple, comfortable sample collection that can be done in any clinical setting or at home.

Dramatically lower cost

Designed to be a fraction of the cost of current LDCT screening, making broad population screening economically viable.

Lower false positive rate

Early research from NCI reported a false positive rate of <17% — notably lower than the roughly 25% often seen with LDCT screening.[3][4]

Scalable to population level

No special equipment or trained specialists required — designed for the clinic, the lab kit, and eventually self-administered use.

LDCT (Current) BioncoDx
Cost per test $300–450 Significantly lower
Collection CT facility required Any location
Equipment needed $100k+ scanner None at collection
False positive rate ~25%[3] <17%[4]
Patient comfort Radiation exposure Non-invasive
Screening reach ~18.7% compliance[1] Designed for all

Of the 12.8M+ Americans eligible for annual lung cancer screening:

12.8M+ eligible patients
~18.7%
Eligible for screening
Actually screened today
~80-82% are never screened[1]
Market Opportunity

A $6.7 billion market[5]
and growing.

The lung cancer screening market is expanding rapidly, driven by aging populations, widening eligibility guidelines, and increasing awareness. BioncoDx is positioned to lead the next generation of this market.

Scale of impact
Lung Cancer Screening Market ($ Billion)
$3.3B
2023
$3.9B
2025
$4.7B
2027
$5.6B
2029
$6.7B
2031

Source: Fortune Business Insights. Market growing at ~9% annually; early detection segment at ~14%.

12.8M
Americans are eligible for annual lung cancer screening under current U.S. Preventive Services Task Force criteria. The American Cancer Society's broader criteria would raise this number by several million.
US Revenue Opportunity at Scale
Eligible for screening 12.8M
Tests per patient per year × 1
Price per test $99
Program annual revenue ~$1.2 Billion
Our Products

Three formats.
Maximum reach.

BioncoDx is developing three distinct product formats designed to reach patients across every point of care — from specialist clinics to the patient's own home.

BioncoDx delivery channels — clinic, lab, and home
BDX Remote
Clinic & Physician Network
Processed through BioncoDx's own CLIA-certified labs using our mass spectrometry equipment and algorithm. Distributed through oncology, pulmonology, and primary care physician networks. The first product to market.
→ Initial commercial launch
BDX Lab Kit
Partner Lab Networks
A full-package kit solution for established national lab partners such as Labcorp and Quest — enabling them to collect, process, and generate results using our assay under sub-license, leveraging their vast geographic reach.
→ Phase 4–5 deployment
BDX Personal Kit
Direct-to-Consumer
A self-administered screening kit for retail and digital channels — CVS, Walgreens, Walmart, and online. Designed to remove all remaining barriers to access and enable population-scale screening.
→ Broad distribution phase
The Science

Molecular precision.
No imaging required.

BioncoDx laboratory

BioncoDx's platform is built on patented biomarker technology and associated metabolites licensed from the National Cancer Institute, advanced through collaboration with Penn State University and other academic institutions. It employs liquid chromatography–mass spectrometry (LC-MS) to detect a defined panel of cancer-associated metabolites from a non-invasive liquid biopsy sample.

The technology identifies metabolite biomarkers associated with lung cancer, delivering clinically relevant information without imaging equipment, radiation, or invasive procedures. Initial validation data has been published in peer-reviewed literature.

1

Liquid Biopsy Collection

A simple, non-invasive sample is collected — no specialized facility or equipment needed. Designed to be feasible during a routine clinical visit.

2

LC-MS Biomarker Analysis

The sample is processed through liquid chromatography–mass spectrometry, precisely measuring a defined panel of cancer-associated metabolites.

3

Machine Learning Algorithm

A validated algorithm evaluates the biomarker profile and generates a clinically actionable result — supporting early detection and risk stratification.

4

Clinical Report

Results are delivered to the ordering physician, enabling earlier intervention and follow-up — when outcomes are most impactful.

Development Timeline

From validated science
to commercial reality.

BioncoDx is advancing through a staged development pathway from initial clinical validation toward regulatory approval and broad commercial deployment.

Phase 1 · Complete
Initial Validation
  • NCI-developed biomarkers
  • Retrospective clinical studies
  • Peer-reviewed publications
  • Patent portfolio secured
Phase 2 · Active · 0–18 mo
Expanded Clinical Trials
  • Multi-site patient recruitment
  • CLIA lab launch
  • NY State approval
  • Algorithm refinement
Phase 3 · 18–30 mo
Regulatory Approval
  • FDA submissions
  • Data generation for review
  • Reimbursement pathway
  • Physician-based distribution
Phase 4 · 24–36 mo
Initial Launch
  • Oncology & pulmonology networks
  • Revenue-generating service
  • LDCT prioritization tool
  • Lab kit partnerships
Phase 5 · 36+ mo
Broad Distribution
  • Mass-market screening
  • Consumer-friendly formats
  • Retail & digital channels
  • Additional cancer indications
Our Team

World-class science.
Proven execution.

BioncoDx brings together leading experts in oncology, mass spectrometry, and business development — united by the mission to make cancer detection more accessible.

Dr. Andrew Patterson
Dr. Andrew Patterson
Co-Founder & Chief Science Officer
John T. and Paige S. Smith Professor and H. Thomas and Dorothy Willits Hallowell Chair in Agricultural Sciences at Penn State. World-leading expert in mass spectrometry–based metabolite profiling. Author of 180+ peer-reviewed manuscripts. NIH-funded. Original co-inventor of the core biomarker technology.
Dr. Patrick Ma
Dr. Patrick Ma
Co-Founder & Chief Medical Officer
Professor of Medicine–Hematology/Oncology at Louisiana State University. Published in Nature Medicine, Cancer Research, and NEJM. 20+ years of clinical trial experience across leading cancer centers in the US.
Peter Winn
Peter Winn
Co-Founder, CEO & CFO
25+ years of business development and company-building experience. Founded three companies that became market leaders with aggregate revenues exceeding $1 billion. Wharton/University of Pennsylvania MBA, Princeton University BA.
Get Involved

Be part of the breakthrough.

BioncoDx is seeking sponsorship partners to advance expanded clinical trials and accelerate the path to regulatory approval. Your support directly enables broader, earlier cancer detection at scale.

Sources & Notes
[1] American Cancer Society analysis of the 2024 National Health Interview Survey, published in JAMA (2025): 12.76M eligible under current USPSTF criteria; 18.7% reported being up to date with screening.
[2] National Cancer Institute SEER Program; American Cancer Society lung cancer survival statistics.
[3] National Lung Screening Trial (NLST) and published literature on LDCT false positive rates in screening populations.
[4] Early-stage NCI biomarker research underlying the BioncoDx platform. Data reflects preliminary findings; not yet validated in a pivotal clinical trial.
[5] Fortune Business Insights — Lung Cancer Screening Market Report. Market projections based on report data; figures may be updated as newer editions are published.