DiaCarta

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.

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

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

• Molecular diagnostic kits
• Cancer mutation detection
• Liquid biopsy tests
• Clinical laboratory services
• Infectious disease PCR

Headquarters

HQ city

Hayward

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. 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.
2. 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.
3. 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.
4. Distribution Revenue: Revenue through distribution partners such as Arrow Diagnostics for ColoScape™ in Italy, San Marino & Vatican City.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels7 records

Core 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

Named customers5 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Capstone Health AlliancecoreChannel Partner/ Reseller/ Distributor · 27 June 2024Strategic 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 or Co-development Partner · 27 February 2024Strategic 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/HMLminorImplementation/ SI/ Consulting Partner · 24 July 2023Partnership 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 CentercoreStrategic or Co-development Partner · 15 October 2018Clinical 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 DiagnosticscoreChannel Partner/ Reseller/ Distributor · 2 July 2018Exclusive 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.
• MIODxminorStrategic or Co-development Partner · 16 April 2018Joint 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 BiosciencecoreTechnology or IntegrationOncuria® 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

Direct 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

• Xtwitter.com/diacarta_dx
• LinkedInlinkedin.com/company/diacarta

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries3 records

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about DiaCarta