Singlera Genomics
Singlera Genomics is a privately held molecular diagnostics company developing non-invasive liquid biopsy tests for early cancer detection using proprietary ctDNA methylation platforms (mTitan, mGuard, MONOD), serving laboratories, pharmaceutical companies, and academic researchers across the US, China, and Europe.
- Company typePrivate
- Founded2014
- HeadquartersLa Jolla, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What Singlera Genomics does
Singlera Genomics Inc., founded in 2014 and headquartered in La Jolla, California with additional offices in Chengdu, Shanghai, Taizhou, and Yangzhou, is a privately held molecular diagnostics company developing non-invasive liquid biopsy tests for early cancer detection. Its core technology is circulating tumor DNA (ctDNA) methylation analysis, built around three proprietary platforms: mTitan (targeted methylation detection with a single-day workflow and up to 80% molecular conversion rate), mGuard (multi-gene methylation liquid biopsy with detection limits as low as 0.05%), and MONOD (whole-genome methylation enrichment scanning via methylation haplotype analysis). The commercial product portfolio includes ColonAiQ (NMPA Class III-certified colorectal cancer screening), ColonES, GutSeer (multi-gastrointestinal cancer detection across five cancer types), PDACatch (FDA Breakthrough Device Designation for pancreatic adenocarcinoma), Personalized MRD for treatment monitoring, POCT kits, and the CaptureRevo NAE24 nucleic acid extraction instrument.
Singlera serves three primary customer segments: healthcare providers and medical laboratories offering early cancer screening and prognostic monitoring to high-risk patients, pharmaceutical companies such as Astellas pursuing methylation-based research tools and companion diagnostics, and academic institutions such as Fudan University, the University of Pittsburgh, UCSD, and Xiang Ya Hospital for large-scale cancer screening studies including the 200,000-volunteer Taizhou Longitudinal Study. Revenue is generated through a partner-led distribution model rather than direct sales, with products commercialized as Laboratory Developed Tests (LDTs) by CAP/CLIA-certified partners (Breakthrough Genomics in California, Clinomics USA), via European distribution and research agreements (Pure Medical), and through research collaborations and potential milestone payments with pharmaceutical partners. The company has raised approximately $230 million+ across disclosed funding rounds and reports a workforce of 101-250 employees.
Singlera Genomics firmographics
Firmographics- Name
- Singlera Genomics
- Legal name
- Singlera Genomics Inc.
- Website
- https://singlera.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Singlera Genomics is a privately held molecular diagnostics company developing non-invasive liquid biopsy tests for early cancer detection using proprietary ctDNA methylation platforms (mTitan, mGuard, MONOD), serving laboratories, pharmaceutical companies, and academic researchers across the US, China, and Europe.
- Ownership category
- akta.pro rank
Singlera Genomics industry classification
Industry- Product category
- Cancer Diagnostics and Liquid Biopsy
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (6215)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)
- akta.pro secondary industries
- Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where Singlera Genomics is headquartered
LocationHeadquarters
- HQ city
- La Jolla
- HQ country
- United States
- HQ region
- North America
Offices5 records
Markets served
Singlera Genomics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Testing Services: Singlera provides cancer detection tests through partner laboratories as Laboratory Developed Tests (LDTs). Partners including Breakthrough Genomics and Clinomics offer Singlera's products including ColonES, PDACatch, and PanSeer through their CAP and CLIA-certified labs in the US and globally.
- Product Distribution Agreements: European distribution and research agreement with Pure Medical to distribute cancer detection assays across European countries. Revenue generated from sale of assay products including mTitan and mGuard-based products.
- Pharmaceutical Research Collaborations: Collaborations with pharmaceutical companies like Astellas for methylation-based research tools to understand biological reactions to pharmaceuticals. May include milestone payments and research funding.
Go-to-market motion1 record
Distribution channels4 records
Marketing channels4 records
Singlera Genomics product offering
Product offeringCore offering
Singlera Genomics develops and commercializes non-invasive liquid biopsy tests for early cancer detection using proprietary circulating tumor DNA (ctDNA) methylation analysis. The company offers a portfolio of blood-based diagnostic products (ColonAiQ, ColonES, GutSeer, PDACatch, PanSeer, Personalized MRD) built on three technology platforms (mTitan, mGuard, MONOD) and distributes them through partner laboratories and distribution agreements.
Product overview
Singlera Genomics offers a comprehensive portfolio of cancer early detection and diagnostic products built on three core technology platforms: mTitan (targeted methylation detection with single-day workflow), mGuard (multi-gene methylation liquid biopsy with 3-20 gene detection), and MONOD (whole genome methylation enrichment). The product lineup centers on liquid biopsy tests for early cancer detection including ColonAiQ (colorectal cancer, NMPA-certified), ColonES (colorectal cancer via NGS), GutSeer (gastrointestinal cancers covering 5 cancer types), and PDACatch (pancreatic cancer, FDA Breakthrough Device Designation). Supporting offerings include Personalized MRD for treatment monitoring, POCT kits for point-of-care testing, and CaptureRevo NAE24 automated nucleic acid extraction system. The company serves the global market through distribution partnerships and laboratory services.
Differentiator
Problem solved
Functional benefit
Brands
- PDACatch: Liquid biopsy assay for early detection of pancreatic adenocarcinoma (PDAC) in high-risk individuals, granted FDA Breakthrough Device Designation
- ColonAiQ
- ColonES
- GutSeer
- BT-Reveal
- PanSeer
- mTitan
- mGuard
- MONOD
- CaptureRevo
- Gutfocus
Products and services
- PDACatch Liquid biopsy assay with FDA Breakthrough Device Designation for early detection of pancreatic adenocarcinoma (PDAC) in high-risk individuals, using proprietary DNA methylation technology on circulating tumor DNA. Demonstrated ability to detect cancer four years before conventional methods.
- ColonAiQ Multi-locus blood-based assay targeting circulating tumor DNA methylation for non-invasive early detection of colorectal cancer and advanced adenoma. NMPA Class III medical device registered.
- ColonES Blood-based colorectal cancer screening assay using circulating tumor DNA methylation signals captured via high-throughput next-generation sequencing, offering superior sensitivity and specificity compared to stool-based methods.
- GutSeer Non-invasive blood-based assay for early detection and localization of gastrointestinal cancers using cell-free DNA methylation and fragmentation signatures across a 1656 target region panel, covering colorectal, gastric, liver, esophageal, and pancreatic cancers.
- Personalized MRD Liquid biopsy assay for personalized minimal residual disease monitoring and relapse prediction. Analyzes DNA methylation alterations and fragmentation patterns in circulating tumor DNA to distinguish cancerous from non-cancerous cell-free DNA.
- POCT Kits Point-of-care testing kits including Fecal Occult Blood Diagnostic Test, Fecal Occult Blood and Transferrin Diagnostic Test, and H.Pylori Antigen Diagnostic Test, using colloidal gold method for rapid results.
- CaptureRevo NAE24 Automated nucleic acid extraction system using magnetic bead-based technology with touch screen interface, UV sterilization, heating up to 120°C, completing extraction in 10-60 minutes per run with Ethernet and Wi-Fi connectivity.
- PanSeer Pan-cancer screening technology for early detection of multiple cancer types from a single blood test.
- BT-Reveal Early pancreatic cancer test offered by Breakthrough Genomics using PDACatch technology. Detects early stages of pancreatic cancer from a simple blood draw, identifying cancer signals before symptoms appear.
Quantifiable outcome
- Detected cancer signals 4+ years before conventional diagnosis using blood test
- +4 more outcomes
Companies that use Singlera Genomics
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles3 records
Singlera Genomics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature9 records
Singlera Genomics partnerships and signals
Strategic signalPartnerships
Ten partnerships are on record, tiered core, major and minor.
- Pure MedicalcoreEuropean distribution and research agreement with Pure Medical, a European-based medical company. Collaboration on cancer detection research and distribution of assays including mTitan and mGuard across several European countries. Aims to facilitate early, non-invasive detection of various cancers.
- University of PittsburghcoreResearch collaboration with University of Pittsburgh and Breakthrough Genomics to evaluate BT-Reveal early pancreatic cancer test. Test utilizes DNA methylation technology on mTitan platform to detect cancer signals in circulating DNA before symptoms appear. Preclinical study step towards larger FDA longitudinal study for pancreatic cancer screening.
- Breakthrough GenomicscoreStrategic cooperation agreement for pancreatic cancer screening service in California. Singlera provides technical support using PDACatch technology. Breakthrough Genomics operates CAP and CLIA-certified genomics laboratory in Irvine offering LDT services. Strategic cooperation agreement signed in 2022.
- Clinomics USAcoreStrategic cooperation agreement with Clinomics USA (South Korean company Clinomics subsidiary) for early cancer detection services. Plans to establish global strategic partnership for early cancer detection based on liquid biopsy. Launching ColonES, PDACatch, and PanSeer testing services through Clinomics Irvine CLIA Lab.
- Astellas PharmamajorResearch collaboration with Astellas Pharma pursuing methylation-based tools to better understand biological reactions to pharmaceuticals. Part of Astellas's research efforts to develop companion diagnostics and understand drug response mechanisms.
- Fudan UniversitymajorLongitudinal study collaboration with Fudan University on 200,000 volunteer cohort (Taizhou Longitudinal Study). Joint research demonstrating detection of five common cancers earlier than standard tests and pan-cancer early detection results published in Nature Communications.
- Fudan Taizou InstitutemajorResearch partnership with Fudan Taizou Institute for cancer early detection studies.
- University of California San DiegominorAcademic partnership with UCSD for genomics research collaboration.
- Xiang Ya HospitalminorClinical partnership with Xiang Ya Hospital for cancer diagnostics research.
- ClinomicscoreSouth Korean biomedical innovation company dedicated to liquid biopsy and multi-omics-based early cancer diagnostic technologies. Strategic partner for global market expansion including US, Europe, Japan, and South Korea markets.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
Singlera Genomics competitors and assessment
Company assessmentBroad incumbents
- Foundation Medicine: Foundation Medicine (a Roche subsidiary) provides comprehensive genomic profiling of solid tumors using circulating and tissue-based DNA/RNA assays. While broader than Singlera's methylation focus, Foundation Medicine overlaps significantly in oncology molecular diagnostics and uses similar NGS-based ctDNA workflows.
- NeoGenomics: NeoGenomics operates a global oncology testing laboratory network offering liquid biopsy, molecular diagnostics, and pathology services through its Pharma Services and Clinical Services divisions. Its RaDaR MRD assay and broad oncology menu make it a broad incumbent competing across Singlera's product portfolio.
Direct peers
- Natera: Natera's Signatera is a leading personalized MRD test using tumor-informed ctDNA analysis. Singlera's Personalized MRD product uses methylation-based (rather than mutation-based) ctDNA signatures to perform the same minimal residual disease monitoring function for oncology patients.
- Guardant Health: Guardant Health is a leading liquid biopsy company offering Guardant360 for tumor mutation profiling and Guardant Reveal for MRD, both based on circulating tumor DNA. Singlera's methylation-based ctDNA tests and Personalized MRD product directly compete in the same oncology liquid biopsy space.
- GRAIL: GRAIL is the most direct multi-cancer early detection (MCED) competitor, developing the Galleri blood test that screens for multiple cancer signals from a single draw. Like Singlera, GRAIL uses next-generation sequencing on blood-derived cell-free DNA and targets the same MCED market segment.
- Exact Sciences: Exact Sciences markets Cologuard, the leading non-invasive colorectal cancer screening test, and acquired Thrive Earlier Detection to enter MCED. Singlera's ColonES, ColonAiQ, and GutSeer compete directly with Cologuard in colorectal screening and with Thrive's CancerSEEK in MCED.
- Freenome: Freenome is a multiomics liquid biopsy company developing tests for early cancer detection using cfDNA, methylomics, and proteomics. Freenome's first product targets colorectal cancer screening, directly competing with Singlera's ColonES and ColonAiQ.
Emerging players
- Personalis: Personalis provides ultra-sensitive ctDNA-based MRD (NeXT Personal) and tumor profiling services, primarily through pharma and clinical research channels. Personalis's MRD focus and ultra-sensitive ctDNA detection compete with Singlera's Personalized MRD and methylation-based approaches.
Regional players
- Burning Rock Biotech: Burning Rock is a China-based oncology liquid biopsy company offering cancer therapy selection and MRD tests using NGS-based ctDNA analysis. It directly competes with Singlera's methylation-based ctDNA products in the Chinese market where Singlera also operates.
- Genetron Holdings: Genetron is a China-based precision oncology company offering NGS-based cancer screening, diagnosis, and monitoring products, including MRD and early detection assays. Genetron directly competes with Singlera in the Chinese oncology liquid biopsy market with similar ctDNA-based approaches.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Singlera Genomics social profiles
Digital presenceSinglera Genomics compliance and trust
Trust signalCompliance2 records
Singlera Genomics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Singlera Genomics leadership team
Management profileNumber of profiles
Profiles5 records
Singlera Genomics subsidiaries and ownership
Company hierarchySubsidiaries2 records
Singlera Genomics funding detail
Funding detailFunding overview
Funding rounds5 records
Investors24 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Singlera Genomics 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 Singlera Genomics
What does Singlera Genomics do?
Singlera Genomics develops and commercializes non-invasive liquid biopsy tests for early cancer detection using proprietary circulating tumor DNA (ctDNA) methylation analysis. The company offers a portfolio of blood-based diagnostic products (ColonAiQ, ColonES, GutSeer, PDACatch, PanSeer, Personalized MRD) built on three technology platforms (mTitan, mGuard, MONOD) and distributes them through partner laboratories and distribution agreements.
Is Singlera Genomics a public or private company?
Singlera Genomics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Singlera Genomics founded?
Singlera Genomics was founded in 2014. It employs 101 to 250 people.
Where is Singlera Genomics based?
Singlera Genomics is headquartered in La Jolla, United States, in the North America region.
How does Singlera Genomics make money?
Three revenue lines are on record. Diagnostic Testing Services are the primary driver. The others are product Distribution Agreements and pharmaceutical Research Collaborations.
Who are Singlera Genomics's main competitors?
Broad incumbents on record are Foundation Medicine and NeoGenomics. Direct peers are Natera, Guardant Health, GRAIL, Exact Sciences and Freenome. Personalis is listed as an emerging player. Regional players are Burning Rock Biotech and Genetron Holdings.
Does Singlera Genomics have an API?
No public API is recorded for Singlera Genomics.
What industry is Singlera Genomics in?
Singlera Genomics's product category is Cancer Diagnostics and Liquid Biopsy. Its primary akta.pro industry code is HLAAANAG, Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing, with a secondary code of HLAAAMAH, Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes). Its NAICS code is 325413 and its SIC code is 2835.