SAGA Diagnostics
- Company typePrivate
- Founded2016
- HeadquartersMorrisville, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
SAGA Diagnostics firmographics
Firmographics- Name
- SAGA Diagnostics
- Legal name
- SAGA Diagnostics US, Inc.
- Website
- https://sagadiagnostics.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Ownership category
- akta.pro rank
SAGA Diagnostics industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Medical Laboratories (8071)
- akta.pro primary industry
- Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)
- akta.pro secondary industries
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where SAGA Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Morrisville
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
SAGA Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales
Revenue model
- Clinical Laboratory Diagnostic Testing: SAGA operates a CLIA-certified laboratory offering the Pathlight MRD test to healthcare providers and patients in the U.S. Revenue is generated through Medicare reimbursement (for early-stage breast cancer) and commercial payor billing.
- Biopharma Testing Services: SAGA provides contract testing services to biopharma companies using Pathlight for clinical studies, biomarker discovery, trial enrollment support, and drug development programs. Services are tailored to each biopharma partner across early through late-stage cancer development programs.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Medicare Reimbursement - Early-stage Breast Cancer |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels6 records
SAGA Diagnostics product offering
Product offeringCore offering
SAGA Diagnostics develops and commercializes Pathlight, an ultra-sensitive, blood-based molecular residual disease (MRD) test that combines whole genome sequencing with proprietary multiplex digital PCR to detect and track structural variants in circulating tumor DNA. The company operates a CLIA-certified laboratory in Morrisville, NC, providing diagnostic testing services to U.S. healthcare providers (initially for early-stage breast cancer recurrence monitoring) and biopharma companies for clinical trial support, biomarker discovery, and drug development programs.
Product overview
SAGA Diagnostics offers a unified product portfolio centered on the Pathlight MRD platform. Pathlight is a first-of-its-kind, tumor-informed multi-cancer molecular residual disease (MRD) test that combines whole genome sequencing with proprietary multiplex digital PCR to detect and track structural variants as biomarkers for ultra-sensitive cancer recurrence monitoring. The platform serves both commercial clinical testing (initially for early-stage breast cancer with expansion to colorectal cancer) and biopharma partnership services for clinical trial support and drug development programs.
Differentiator
Problem solved
Functional benefit
Brands
- Pathlight: Ultra-sensitive, blood-based, multi-cancer molecular residual disease (MRD) test platform that uses whole genome sequencing and digital PCR to detect structural variants for cancer recurrence monitoring.
Products and services
- Pathlight MRD Test Ultra-sensitive, blood-based, multi-cancer molecular residual disease (MRD) test that uses whole genome sequencing to identify tumor-specific structural variants and digital PCR to detect circulating tumor DNA at sub-part-per-million levels. Indicated for cancer recurrence monitoring and treatment response assessment, initially in early-stage breast cancer and expanded to colorectal cancer. Sold to oncologists, cancer centers, and academic medical centers.
- Biopharma Testing Services Contract ctDNA-based liquid biopsy testing services for biopharma clinical development and translational research, including biomarker discovery, trial enrollment support, and longitudinal clinical trial monitoring using the Pathlight platform across solid tumors and hematologic malignancies. Sold to pharmaceutical and biotechnology companies of all sizes.
Quantifiable outcome
- 100% sensitivity, 100% specificity, 13.7-month lead time to recurrence in stage I-III breast cancer
- +3 more outcomes
Companies that use SAGA Diagnostics
Customer profileNamed customers3 records
Segments2 records
Ideal customer profiles2 records
SAGA Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability2 records
Feature4 records
SAGA Diagnostics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered flagship and core.
- Foundation Medicine (Roche subsidiary)flagshipRoche entered into definitive merger agreement to acquire SAGA Diagnostics for up to $595 million. Following closing (expected Q3 2026), Foundation Medicine will integrate SAGA's Pathlight platform into its diagnostic portfolio. Plans to leverage Roche's AXELIOS sequencing and Digital LightCycler PCR platforms for decentralized MRD solutions.
- Top 10 Pharmaceutical Companies (unnamed)corePathlight is being used in clinical studies by multiple top 10 pharmaceutical companies for drug development, biomarker discovery, and clinical trial support. SAGA partners with biopharma companies of all sizes and development stages.
Scale indicators4 records
Recent moves6 records
Expansion highlights6 records
SAGA Diagnostics competitors and assessment
Company assessmentDirect peers
- Natera: Natera's Signatera is the leading tumor-informed MRD test using a personalized, multiplexed PCR (SNV-based) approach; it is the most directly comparable competitor in commercial-scale MRD testing for solid tumors.
- Guardant Health: Guardant Health's Guardant Reveal is a tumor-informed MRD product using a hybrid methylation/ctDNA approach. Guardant is a direct peer in liquid biopsy and MRD, with deeper commercial payor coverage in oncology.
- Personalis: Personalis offers NeXT Personal, a tumor-informed MRD test for solid tumors. It competes head-to-head with Pathlight in personalized ctDNA MRD detection, particularly in lung and breast cancer indications.
- NeoGenomics: NeoGenomics sells RaDaR, a tumor-informed personalized MRD assay using dPCR-based SNV detection. It is a direct peer in oncology-focused MRD and offers additional clinical lab services overlap.
Broad incumbents
- Foundation Medicine: Foundation Medicine (a Roche subsidiary) is both the acquirer of SAGA and a broad incumbent in comprehensive genomic profiling; its broad CGP menu overlaps with Pathlight's tumor-informed testing approach as a platform partner.
- Exact Sciences: Exact Sciences' Oncology segment (including Oncodetect MRD) competes in MRD and blood-based cancer detection. It is a broader diagnostic incumbent with a large commercial salesforce and established payor relationships.
- Tempus AI: Tempus operates in molecular residual disease and broad oncology profiling (xT, xR, xF). It overlaps with SAGA's clinical and biopharma use cases and benefits from a larger installed base and data footprint.
Emerging players
- Caris Life Sciences: Caris offers MI Profile and is expanding into MRD and liquid biopsy. It overlaps with SAGA's biopharma partnering model and molecular profiling offerings, but with broader multi-omics positioning.
- Inivata (now part of NeoGenomics): Inivata's RaDaR/InVision products target MRD with a personalized assay approach; folded into NeoGenomics, it remains relevant as a competing MRD technology stack with similar indications to Pathlight.
Regional players
- Burning Rock Biotech: Burning Rock is a China-based oncology liquid biopsy and MRD company. While geographically separate, it represents the international MRD/liquid-biopsy cohort and competes in the same indication landscape globally.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
SAGA Diagnostics social profiles
Digital presenceSAGA Diagnostics compliance and trust
Trust signalCompliance4 records
SAGA Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
SAGA Diagnostics leadership team
Management profileNumber of profiles
Profiles4 records
SAGA Diagnostics subsidiaries and ownership
Company hierarchySubsidiaries3 records
SAGA Diagnostics funding detail
Funding detailFunding overview
Funding rounds6 records
Investors9 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SAGA Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SAGA Diagnostics
What does SAGA Diagnostics do?
SAGA Diagnostics develops and commercializes Pathlight, an ultra-sensitive, blood-based molecular residual disease (MRD) test that combines whole genome sequencing with proprietary multiplex digital PCR to detect and track structural variants in circulating tumor DNA. The company operates a CLIA-certified laboratory in Morrisville, NC, providing diagnostic testing services to U.S. healthcare providers (initially for early-stage breast cancer recurrence monitoring) and biopharma companies for clinical trial support, biomarker discovery, and drug development programs.
Is SAGA Diagnostics a public or private company?
SAGA Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was SAGA Diagnostics founded?
SAGA Diagnostics was founded in 2016. It employs 11 to 50 people.
Where is SAGA Diagnostics based?
SAGA Diagnostics is headquartered in Morrisville, United States, in the North America region.
How does SAGA Diagnostics make money?
Two revenue lines are on record. Clinical Laboratory Diagnostic Testing is the primary driver. The others are biopharma Testing Services.
Who are SAGA Diagnostics's main competitors?
Direct peers on record are Natera, Guardant Health, Personalis and NeoGenomics. Broad incumbents are Foundation Medicine, Exact Sciences and Tempus AI. Emerging players are Caris Life Sciences and Inivata (now part of NeoGenomics). Burning Rock Biotech is listed as a regional player.
Does SAGA Diagnostics have an API?
No public API is recorded for SAGA Diagnostics.
What industry is SAGA Diagnostics in?
SAGA Diagnostics's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAAANAG, Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing, with a secondary code of HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 621511 and its SIC code is 8071.