DiaCarta
DiaCarta is a precision molecular diagnostics company that develops XNA technology-based cancer mutation detection kits (QClamp, ColoScape, RadTox, Oncuria) and operates a CAP/CLIA-certified clinical lab, serving hospitals, oncology clinics, and research institutions globally.
- Company typePrivate
- Founded2011
- HeadquartersHayward, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What DiaCarta does
DiaCarta is a privately held precision molecular diagnostics company founded in 2011 and headquartered in California, developing ultra-sensitive cancer mutation detection tests built on its proprietary XNA (Xenonucleic Acid) molecular clamp platform and isobDNA™/SuperbDNA™ signal amplification chemistry. The core technical differentiator is the XNA platform: xenonucleic acid oligomers hybridize to wild-type DNA and block amplification, enabling selective enrichment of mutant sequences at 0.1–0.5% variant allele frequency without deep sequencing — sensitivity that materially exceeds Sanger sequencing (20–25% VAF), pyrosequencing (5–8% VAF), and standard NGS (1–5% VAF). The OptiSeq™ NGS layer leverages this chemistry to reduce sequencing depth by up to 100X (500 OptiSeq reads claimed equivalent to 50,000 conventional reads). DiaCarta monetizes through two primary channels: (1) direct sales of CE/IVD-marked diagnostic kits (QClamp®, ColoScape™, QFusion™, QuantiVirus™) and research-use-only products, and (2) clinical laboratory testing services delivered through its CAP-accredited, CLIA-certified California laboratory, which also validates third-party biomarker assays as Laboratory Developed Tests.
The portfolio spans oncology (QClamp single-gene panels for KRAS/NRAS/EGFR/BRAF/JAK2/PIK3CA, ColoScape colorectal cancer test, Oncuria® bladder cancer suite, OncoAssure Prostate, QFusion lung fusions, MGMT brain cancer, RadTox™ cfDNA radiation therapy monitoring), infectious disease (QuantiVirus SARS-CoV-2, FDA EUA Mpox, Respiratory 4-Plex), and rare disorders (VEXAS syndrome). Target customers include hospitals, cancer centers, pathology laboratories, academic research institutions, and government health agencies; named relationships include Fred Hutchinson Cancer Center, University of Florida Health Cancer Center, Olivia Newton-John Cancer Research Institute, the US FDA Research Group, and the Florida Health Department (statewide RadTox deployment via the Casey DeSantis Florida Cancer Innovation Fund, March 2024). Distribution is global — exclusive Arrow Diagnostics partnership for Italy, Capstone Health Alliance GPO access, wholly-owned clinical and sequencing operations in Nanjing and offices in Shanghai, plus research collaborations in Australia. The company has raised approximately $45M in equity (Series B, February 2018, from BVCF, Fortune Fountain Capital, Good Health Capital) plus $2.3M in NCI SBIR grants, holds 80+ patents around the XNA platform, and explored but terminated a SPAC business combination with HH&L Acquisition Co. in 2023. Medicare coverage for both RadTox™ and Oncuria® became effective January 1, 2024.
DiaCarta firmographics
Firmographics- Name
- DiaCarta
- Legal name
- DiaCarta, Inc.
- Website
- https://diacarta.com
- Company type
- Private
- Founded year
- 2011
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- DiaCarta is a precision molecular diagnostics company that develops XNA technology-based cancer mutation detection kits (QClamp, ColoScape, RadTox, Oncuria) and operates a CAP/CLIA-certified clinical lab, serving hospitals, oncology clinics, and research institutions globally.
- Ownership category
- akta.pro rank
DiaCarta industry classification
Industry- Product category
- Molecular Diagnostics / Cancer Genomics
- NAICS
- Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)
- akta.pro secondary industries
- Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges) (HLAHAOAI), Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)
Keywords
Where DiaCarta is headquartered
LocationHeadquarters
- HQ city
- Hayward
- HQ country
- United States
- HQ region
- North America
Offices5 records
Markets served
DiaCarta business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales, Supply Chain
Revenue model
- IVD Kit Sales: Sale of CE/IVD marked diagnostic kits (QClamp gene mutation tests, ColoScape colorectal cancer test, RadTox cfDNA test, HPV tests, respiratory tests, Mpox tests) and research-use-only products for cancer gene mutation detection.
- Clinical Laboratory Testing Services: CAP/CLIA certified laboratory services offering clinical sample testing including RadTox™ cfDNA monitoring, Oncuria® bladder cancer tests, OptiSeq™ NGS panels, and single-gene QClamp® qPCR tests.
- Prostate Cancer Test Collaboration: Lab Developed Test (LDT) validation and commercialization services for OncoAssure Prostate test through their CAP/CLIA laboratory, including CMS billing and reimbursement support.
- Distribution Revenue: Revenue through distribution partners such as Arrow Diagnostics for ColoScape™ in Italy, San Marino & Vatican City.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | QClamp® Gene Mutation Detection Tests available as CE/IVD marked products or research use only |
| Other | Pay-as-you-go | Clinical laboratory testing services through CAP/CLIA certified laboratory |
Go-to-market motion2 records
Distribution channels5 records
Marketing channels7 records
DiaCarta product offering
Product offeringCore offering
DiaCarta develops and sells CE/IVD-marked molecular diagnostic kits and provides CAP/CLIA-certified clinical laboratory testing services for cancer gene mutation detection, treatment response monitoring, and infectious disease detection. Its portfolio spans liquid biopsy tests for colorectal, bladder, lung, prostate, and pan-cancer applications, single-gene qPCR mutation detection assays, NGS targeted sequencing services, and FDA-EUA infectious disease tests, all built on its proprietary XNA molecular clamp and isobDNA™ signal amplification technologies.
Product overview
DiaCarta is a precision diagnostics company offering a portfolio of molecular diagnostic products and clinical testing services for cancer management and infectious diseases. The core platform consists of proprietary XNA (xenonucleic acid) and isobDNA™ technologies that enable ultra-sensitive mutation detection. Key products include: RadTox™ cfDNA Test for radiation therapy response monitoring; ColoScape™ Colorectal Cancer Test for early detection and recurrence monitoring; Oncuria® Bladder Cancer Tests (Detect/Monitor/Predict); QClamp® Gene Mutation Detection Tests for KRAS, NRAS, EGFR, BRAF, JAK2, and PIK3CA; OptiSeq™ NGS Targeted Sequencing services; QFusion™ Fusion Detection Tests for lung cancer (ALK/RET/ROS1); and OncoAssure Prostate Cancer Test. The company also offers infectious disease tests (COVID-19, Flu, RSV, Mpox), VEXAS syndrome tests, diagnostic instruments (luminometers, immunoassay analyzers), and research products including CRISPR-Quest and cfDNA extraction kits. Services are delivered through CLIA-certified laboratory testing and CE-IVD/FDA-cleared kit products.
Differentiator
Problem solved
Functional benefit
Brands
- QClamp®: XNA-based gene mutation detection technology platform for highly sensitive qPCR assays
- RadTox™
- ColoScape™
- SuperbDNA™ (isobDNA™)
- Oncuria®
- OptiSeq™
- QuantiVirus™
- QFusion™
- UriFind®
- QuantiDNA™
- DigiPlex™
- CRISPR-Quest
Products and services
- RadTox™ cfDNA Test Liquid biopsy test that monitors circulating cell-free DNA (cfDNA) in patient plasma during radiation and chemotherapy to detect early treatment response and toxicity, enabling personalized cancer treatment management. First-in-class companion diagnostic.
- ColoScape™ Colorectal Cancer Test Multigene biomarker real-time PCR in vitro diagnostic test that detects mutations in colorectal cancer driver genes from liquid biopsy (plasma) or FFPE tissue samples for early detection, targeted therapy selection, and recurrence monitoring.
- Oncuria® Bladder Cancer Test 10-biomarker urine test for bladder cancer with three specific tests: Oncuria-Detect for detection, Oncuria-Monitor for recurrence monitoring, and Oncuria-Predict for BCG therapy response prediction. Validated by DiaCarta as LDT at its CAP/CLIA-certified laboratory.
- QClamp® Gene Mutation Detection Tests Ultra-sensitive qPCR-based assays for single gene mutation detection including KRAS, NRAS, EGFR, BRAF, JAK2, and PIK3CA. Detects 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted therapy selection and monitoring. Validated on Roche LightCycler 480, Bio-Rad CFX384, and ABI QuantStudio 5.
- OncoAssure Prostate Cancer Test 6-gene expression assay that assesses risk of aggressive prostate cancer post-diagnosis and risk of biochemical recurrence over a 5-year period post-surgery, guiding decisions on active surveillance or reduced monitoring.
- OptiSeq™ NGS Targeted Sequencing CLIA-certified next-generation sequencing service powered by XNA technology that reduces sequencing depth by up to 100X while enabling ultra-sensitive mutation detection (below 0.1%) from liquid biopsy or FFPE samples. Pan-Cancer Panel covers 65 genes with 2,900+ mutation positions.
- iColon™ iFOB At-Home Test (OTC) Fecal occult blood test available in OTC at-home format, designed to complement the ColoScape™ Test for colorectal cancer screening.
- QFusion™ ALK/RET/ROS1 Fusion Detection Tests RT-qPCR kits leveraging XNA technology to detect ROS1, RET, and ALK fusions in non-small cell lung cancer with a LoD of 50 copies of RNA, enabling targeted therapy selection.
- UriFind® Urothelial Carcinoma Test Bladder cancer early detection test using urine samples for urothelial carcinoma detection.
- QuantiVirus™ MPXV qPCR Test FDA Emergency Use Authorized qPCR test for mpox (monkeypox) virus detection.
- Respiratory 4-Plex Test Multiplex PCR test for simultaneous detection of COVID-19, Influenza A & B, and RSV from respiratory samples.
- VEXAS Syndrome Early Detection Test Genetic test for VEXAS syndrome (UBA1 gene mutation) for diagnosis of this rare autoinflammatory disorder.
- MGMT Gene Promoter Methylation Analysis Brain cancer test for MGMT gene promoter methylation status, used to predict response to temozolomide chemotherapy in glioblastoma.
- QClamp® Plex VEXAS UBA1 Mutation Test Plex assay for detection of UBA1 gene mutations associated with VEXAS syndrome.
Quantifiable outcome
- ColoScape liquid biopsy detected cancer mutations in 92% of early-stage colorectal cancer cases
- +4 more outcomes
Companies that use DiaCarta
Customer profileNamed customers5 records
Segments5 records
Ideal customer profiles3 records
DiaCarta technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
DiaCarta partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- Capstone Health AlliancecoreStrategic collaboration bringing DiaCarta's diagnostic tests to healthcare providers through Capstone Health Alliance, one of the largest regional group purchasing organizations (GPO) in the US healthcare sector. Aims to enhance patient care through revolutionary diagnostic technologies.
- OncoAssure Ltd.coreStrategic collaboration to commercialize OncoAssure's Prostate prognostic test - a 6-gene expression assay for prostate cancer recurrence risk assessment. DiaCarta's CAP/CLIA laboratory performs LDT validation and handles CMS billing/reimbursement. The test identifies patients with lower risk of recurrence, guiding active surveillance or reduced monitoring decisions post-treatment.
- HMC/HMLminorPartnership for customizing Lab Development Test (LDT) validations and compliance in the US market. Focus on supporting test validation processes and regulatory compliance requirements.
- University of Florida Health Cancer CentercoreClinical collaboration for RadTox™ cfDNA Test development. Dr. Paul Okunieff (Co-Principal Investigator) and Radiation Oncology Team at UFHCC analyzing blood specimens from up to 500 patients undergoing radiotherapy for prostate cancer. NCI-funded Phase II SBIR contract supporting the collaboration.
- Arrow DiagnosticscoreExclusive distribution agreement making Arrow Diagnostics the sole distributor of ColoScape™ multigene biomarker TaqMan qPCR CE-IVD test in Italy, San Marino, and Vatican City. Arrow Diagnostics S.r.l. based in Genoa, Italy distributes reagents, kits, and tools in molecular biology, virology, clinical diagnostics, oncology, and immunology.
- MIODxminorJoint development of diagnostic test to predict patient responses to immunotherapy. Collaboration combining DiaCarta's molecular technologies with MIODx's biomarkers for immuno-oncology applications.
- Nonagen BiosciencecoreOncuria® bladder cancer tests developed by Nonagen Bioscience and validated by DiaCarta as Lab Developed Test (LDT) at its CAP-accredited and CLIA-certified laboratory. Tests include Oncuria-Detect (bladder cancer detection), Oncuria-Monitor (recurrence monitoring), and Oncuria-Predict (BCG therapy response prediction). Medicare coverage effective January 1, 2024.
Scale indicators9 records
Recent moves6 records
Expansion highlights6 records
DiaCarta competitors and assessment
Company assessmentDirect peers
- Exact Sciences: Developer of Cologuard, the leading non-invasive colorectal cancer screening test. Directly comparable to DiaCarta's ColoScape™ liquid biopsy and iColon™ iFOB OTC colorectal cancer products, both targeting CRC screening and recurrence monitoring through stool- and blood-based molecular assays.
- NeoGenomics: Specialized oncology reference laboratory offering molecular and genetic testing services. Closely comparable to DiaCarta's CAP/CLIA clinical lab services for QClamp®, OptiSeq™, OncoAssure Prostate, and Oncuria® tests, serving overlapping hospital and oncology clinic customers.
- Personalis: Cancer genomics company offering ultra-sensitive NGS-based tumor profiling (NeXT Personal®, ImmunoID Next). Comparable to DiaCarta's OptiSeq™ XNA-powered NGS panels and RadTox™ cfDNA services for oncology customers, at similar scale.
- Nonagen Bioscience: Developer of the Oncuria® bladder cancer biomarker panel that DiaCarta validates as an LDT in its CAP/CLIA lab. Closely comparable as a urologic oncology diagnostics developer, and a current DiaCarta commercial partner that could also compete if partnerships shift.
Broad incumbents
- Guardant Health: Leading liquid biopsy company with FDA-approved Guardant360 CDx for comprehensive genomic profiling in oncology. Comparable to DiaCarta's RadTox™ and OptiSeq™ cfDNA NGS services, though Guardant operates at materially larger scale with broader payor coverage.
- QIAGEN: Global molecular diagnostics and sample-preparation leader offering PCR-based oncology kits (e.g., therascreen KRAS, EGFR) directly competitive with DiaCarta's QClamp® gene mutation tests. Much larger established player with broader menu and global distribution.
- Natera: Specialist in cell-free DNA testing for oncology (Signatera™ MRD) and reproductive health. Comparable to DiaCarta's cfDNA-based RadTox™ monitoring and QClamp® liquid biopsy mutation detection, though Natera has stronger commercial traction in MRD.
- Bio-Techne: Life sciences tools and diagnostics company with molecular biology reagents, qPCR enzymes, and diagnostic kits. Comparable to DiaCarta's research products (cfDNA extraction kits, CRISPR-Quest, Plex immunoassays) and QClamp® assay platform, though Bio-Techne is significantly larger and more diversified.
- Hologic: Diversified diagnostics company with strong molecular infectious disease portfolio (Panther Fusion, Aptima). Comparable to DiaCarta's QuantiVirus™ Mpox and Respiratory 4-Plex infectious disease kits, though Hologic is a much larger incumbent with established FDA clearances and global sales force.
- Cepheid (Danaher): Molecular diagnostics leader with the GeneXpert® system running Xpert® tests for infectious disease and oncology. Comparable in qPCR-based diagnostic menu and CLIA lab workflow, though Cepheid's installed instrument base gives it dominant near-patient testing position.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
DiaCarta social profiles
Digital presenceDiaCarta compliance and trust
Trust signalCompliance3 records
DiaCarta financial estimates
Financial estimateRevenue estimate
Valuation estimate
DiaCarta leadership team
Management profileNumber of profiles
Profiles5 records
DiaCarta subsidiaries and ownership
Company hierarchySubsidiaries3 records
DiaCarta funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
DiaCarta 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 DiaCarta
What does DiaCarta do?
DiaCarta develops and sells CE/IVD-marked molecular diagnostic kits and provides CAP/CLIA-certified clinical laboratory testing services for cancer gene mutation detection, treatment response monitoring, and infectious disease detection. Its portfolio spans liquid biopsy tests for colorectal, bladder, lung, prostate, and pan-cancer applications, single-gene qPCR mutation detection assays, NGS targeted sequencing services, and FDA-EUA infectious disease tests, all built on its proprietary XNA molecular clamp and isobDNA™ signal amplification technologies.
Is DiaCarta a public or private company?
DiaCarta is a private company. It is classified as venture growth investor backed and is currently operating.
When was DiaCarta founded?
DiaCarta was founded in 2011. It employs 11 to 50 people.
Where is DiaCarta based?
DiaCarta is headquartered in Hayward, United States, in the North America region.
How does DiaCarta make money?
Four revenue lines are on record. IVD Kit Sales are the primary driver. The others are clinical Laboratory Testing Services, prostate Cancer Test Collaboration and distribution Revenue.
Who are DiaCarta's main competitors?
Direct peers on record are Exact Sciences, NeoGenomics, Personalis and Nonagen Bioscience. Broad incumbents are Guardant Health, QIAGEN, Natera, Bio-Techne, Hologic and Cepheid (Danaher).
Does DiaCarta have an API?
No public API is recorded for DiaCarta.
What industry is DiaCarta in?
DiaCarta's product category is Molecular Diagnostics / Cancer Genomics. Its primary akta.pro industry code is HLAHAAAD, Molecular Diagnostics (PCR/NAAT/NGS-based IVD), with a secondary code of HLAGADAF, Molecular & Genetic Testing (PCR/NGS/qPCR). Its NAICS code is 621511 and its SIC code is 2835.