IntelliGenome
IntelliGenome is a Houston-based molecular diagnostics company founded in 2022 that develops CRISPR-based blood tests for infectious disease detection, with tuberculosis as its lead indication. It serves healthcare laboratories, point-of-care clinics, and resource-limited settings through CLIA lab services, exclusive international distribution partners, and a wholly owned APAC subsidiary.
- Company typePrivate
- Founded2022
- HeadquartersHouston, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What IntelliGenome does
IntelliGenome, Inc. is a Houston-based molecular diagnostics company founded in July 2022 that develops CRISPR-based blood tests for infectious disease detection and treatment monitoring, with tuberculosis (TB) as its lead indication. The company's core technology combines high-efficiency DNA polymerase amplification with a thermostable protein-enhanced CRISPR-Cas fluorescence detection system to identify pathogen-specific DNA sequences at single-nucleotide resolution. Its product portfolio includes the CRISPR-TB Benchtop Assay for high-throughput use in CLIA-certified laboratories, the CRISPR-TB Point of Care Blood Assay built on its proprietary "Lab in Tube" (LIT) portable platform with a reusable fluorescent reader and disposable test kits, and the flagship CRISPR-TB Blood Test designed to detect Mycobacterium tuberculosis cell-free DNA in human serum and EDTA plasma. Research-stage extensions target nontuberculous mycobacteria (NTM) cfDNA detection in blood and oncology cfDNA biomarker assays.
The company's commercial model operates through three primary channels: laboratory services performed by Ruthenium Diagnostics, LLC (a CLIA-certified high-complexity laboratory in Houston under CLIA #45D2310559, billing under CPT/PLA Code PLA 102138), exclusive international distribution partnerships (CTR Scientific in Mexico and Velez Lab S.A.S. in Colombia), and a wholly owned APAC subsidiary (Hangzhou Intelligenome Biotechnology Co., Ltd., established May 2025). Revenue also derives from NIH-funded R&D subaward agreements, including a March 2026 subaward through Cornell University to develop a portable lab-in-tube TB diagnostic. The company has secured FDA Breakthrough Device Designation (January 2025), CE-IVDD certification, and INVIMA sanitary registration in Colombia (June 2026), with multicenter clinical studies planned across the US, Mexico, and Germany.
IntelliGenome serves healthcare laboratories, point-of-care clinics, and resource-limited healthcare settings, with particular focus on patient populations underserved by sputum-based TB diagnostics including pediatric (12% of TB cases), HIV-co-infected (8.2% of cases), and extra-pulmonary TB patients. The platform's primary value proposition is rapid (hours versus weeks for culture), non-sputum-based TB detection from blood, addressing an estimated 3.1 million missed active TB cases annually and a US TB testing market exceeding $2 billion per year. Leadership includes CEO Wilson Zhang, M.D. (20 years in diagnostics corporate development and M&A), CTO Bo Ning, Ph.D. (lead designer of the CRISPR detection chemistry), and CSO/Founder Tony Hu, Ph.D. (AIMBE Fellow, formerly Tulane University, now Tsinghua University).
IntelliGenome firmographics
Firmographics- Name
- IntelliGenome
- Legal name
- IntelliGenome, Inc.
- Website
- https://intelligenome-us.com
- Company type
- Private
- Founded year
- 2022
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- IntelliGenome is a Houston-based molecular diagnostics company founded in 2022 that develops CRISPR-based blood tests for infectious disease detection, with tuberculosis as its lead indication. It serves healthcare laboratories, point-of-care clinics, and resource-limited settings through CLIA lab services, exclusive international distribution partners, and a wholly owned APAC subsidiary.
- Ownership category
- akta.pro rank
IntelliGenome industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD)
- akta.pro secondary industries
- Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA), Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)
Keywords
Where IntelliGenome is headquartered
LocationHeadquarters
- HQ city
- Houston
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
IntelliGenome business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Marketing or Sales, Operations, Others
Revenue model
- CRISPR-TB Blood Test: The company generates revenue through sale of its CRISPR-TB Blood Test kits. The test is performed by Ruthenium Diagnostics, LLC (CLIA #45D2310559) in collaboration with Intelligenome. Test is categorized as Proprietary Laboratory Analysis (PLA) with CPT/PLA Code: PLA 102138. Revenue is derived from laboratory service fees for molecular diagnostic testing performed on patient samples.
- Point-of-Care Testing Solutions: Revenue from portable Lab in Tube (LIT) diagnostic devices and disposable test kits. The system includes portable fluorescent readers sold separately and single-use disposable test kit components for on-site TB testing.
- NIH-Funded R&D Collaboration: IntelliGenome receives funding through R&D subaward agreements with Cornell University as part of NIH-funded programs for developing rapid, low-cost portable TB diagnostics.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | CRISPR-TB Blood Test - Laboratory-based testing service |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels5 records
IntelliGenome product offering
Product offeringCore offering
IntelliGenome develops and commercializes CRISPR-based molecular diagnostic tests that detect pathogen cell-free DNA in blood samples, with the lead application being tuberculosis detection. The company offers a high-throughput CRISPR-TB Benchtop Assay for clinical laboratories and a portable CRISPR-TB Point of Care Blood Assay built on its proprietary Lab in Tube (LIT) platform. Research-stage offerings extend the platform to nontuberculous mycobacteria (NTM) detection and oncology cfDNA biomarker detection.
Product overview
IntelliGenome offers a CRISPR-based molecular diagnostic platform with two main product lines: (1) CRISPR-TB Benchtop Assay for high-throughput laboratory testing in CLIA-certified facilities, and (2) CRISPR-TB Point of Care Blood Assay featuring the Lab in Tube (LIT) portable system for decentralized testing. The platform leverages CRISPR-Cas technology combined with PCR amplification and fluorescent detection to identify pathogen-specific DNA sequences with high sensitivity. The first commercial product is the CRISPR-TB Blood Test for tuberculosis detection from blood samples, addressing pulmonary and extra-pulmonary TB across all patient populations. Research-stage offerings include NTM cfDNA Detection and Oncology cfDNA Detection assays.
Differentiator
Problem solved
Functional benefit
Brands
- Lab in Tube (LIT): Advanced point-of-care molecular diagnostic platform designed for portability, ease of use, and accessibility, integrating all necessary reagents to isolate and detect Mtb cfDNA in a single compact device.
- CRISPR-TB Blood Test
Products and services
- CRISPR-TB Benchtop Assay High-throughput tuberculosis diagnostic assay designed for CLIA-certified laboratories. Detects Mycobacterium tuberculosis cell-free DNA in plasma or serum using CRISPR-based detection combined with real-time PCR amplification, delivering results in hours for pediatric, geriatric, and critically ill populations.
- CRISPR-TB Point of Care Blood Assay Self-contained point-of-care molecular diagnostic solution for ultra-sensitive tuberculosis detection from blood samples. Built on the proprietary Lab in Tube (LIT) platform integrating DNA amplification, CRISPR detection, and TB identification modules in a portable device readable with a portable fluorescent reader.
- CRISPR-TB Blood Test Qualitative in vitro diagnostic test for detection of Mycobacterium tuberculosis complex cell-free DNA in blood samples using CRISPR technology with quantitative PCR. Developed and performed by Ruthenium Diagnostics, LLC (CLIA #45D2310559) in collaboration with IntelliGenome, billed under CPT/PLA Code PLA 102138.
- NTM cfDNA Detection Assay Research-use assay using an isolation-free multiplex RPA-CRISPR detection method to detect nontuberculous mycobacteria cell-free DNA in blood samples. Targets patients with underlying lung conditions such as bronchiectasis or COPD who are at risk for NTM infections.
- Oncology cfDNA Detection
Quantifiable outcome
- First qualitative real-time PCR assay combining CRISPR technology to detect Mtb cell-free DNA in human serum and EDTA plasma
- +2 more outcomes
Companies that use IntelliGenome
Customer profileNamed customers1 record
Segments6 records
Ideal customer profiles2 records
IntelliGenome technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature5 records
IntelliGenome partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core.
- Velez Lab S.A.S.coreVelez Lab S.A.S. appointed as exclusive distribution partner for Colombia under a long-term commercial agreement. The partnership focuses on expanding access to innovative tuberculosis diagnostic solutions throughout Colombia. Plans include collaboration with leading healthcare institutions, researchers, and public health stakeholders to advance evidence generation in pediatric TB, EPTB, and other high-priority populations.
- CTR Scientific (Control Técnico y Representaciones S.A. de C.V.)coreCTR Scientific serves as IntelliGenome's exclusive distribution partner in Mexico. The partnership supports evaluation, commercialization, and future adoption of the CRISPR-TB Blood Test. CTR Scientific leverages its extensive network and expertise to accelerate market development and evaluation throughout Mexico, particularly for pediatric, extrapulmonary, and vulnerable populations.
- Cornell UniversitycoreR&D subaward agreement with Cornell University to develop a rapid, low-cost, portable TB diagnostic solution as part of an NIH-funded program. IntelliGenome contributes its CRISPR-based point-of-care testing platform to create a portable lab-in-tube assay for TB detection from respiratory and blood samples, expanding diagnostic access in settings with limited laboratory infrastructure.
- Ruthenium Diagnostics, LLCcoreRuthenium Diagnostics, LLC (CLIA #45D2310559) develops and performs the CRISPR-TB Blood Test in collaboration with IntelliGenome. Located at 9440 Bellaire Blvd. Suite 110B, Houston, TX 77036. The laboratory performs testing under CLIA regulations for high-complexity testing, providing the primary commercial channel for IntelliGenome's test.
- Tulane University (Tony Hu Research Group)coreProfessor Tony Hu's research group at Tulane University developed the foundational CRISPR detection technology over more than a decade. IntelliGenome licensed and commercialized this technology. Tony Hu serves as AIMBE Fellow, Founder, and Chief Science Advisor to IntelliGenome. The technology represents the culmination of research published in Lancet Microbe and other leading journals.
- Hangzhou Intelligenome Biotechnology Co., Ltd.coreWholly owned company established May 20 as part of APAC expansion. Represents IntelliGenome's continued commitment to strengthening local support, advancing research collaboration, and expanding access to innovative molecular diagnostic solutions across the Asia-Pacific region.
Scale indicators4 records
Recent moves7 records
Expansion highlights7 records
IntelliGenome competitors and assessment
Company assessmentDirect peers
- Sherlock Biosciences: Sherlock Biosciences is a CRISPR-based molecular diagnostics company with SHERLOCK and INSPECTR platforms. It is a direct CRISPR-diagnostics peer, pursuing CRISPR-Cas detection across infectious disease and oncology indications overlapping with IntelliGenome's roadmap.
- Cepheid (Danaher): Cepheid's GeneXpert MTB/RIF is the dominant molecular TB diagnostic on the market. It is the most direct competitor to IntelliGenome's CRISPR-TB platform, addressing the same TB testing market from hospital and reference-lab settings, albeit with a sputum/cartridge-based workflow rather than blood-based CRISPR detection.
- Molbio Diagnostics: Molbio's Truenat MTB is a chip-based real-time PCR molecular TB test designed for decentralized and POC use. It is directly comparable to IntelliGenome's Lab-in-Tube point-of-care platform in targeting rapid, decentralized TB detection in resource-limited settings.
- Hain Lifescience (Bruker): Hain Lifescience (now part of Bruker) provides the FluoroType MTB and related molecular TB/mycobacteria assays. It directly competes with IntelliGenome's CRISPR-TB Benchtop Assay in CLIA-certified and clinical mycobacteriology laboratory workflows.
- Mammoth Biosciences: Mammoth Biosciences is a CRISPR diagnostics company commercializing a Cas12-based DETECTR platform. It is a direct CRISPR-diagnostics peer developing molecular infectious-disease and oncology assays using the same underlying CRISPR-Cas detection chemistry that IntelliGenome applies to TB.
Broad incumbents
- Abbott: Abbott's m2000 RealTime MTB and Alinity m systems are widely deployed molecular TB assays in reference labs and hospitals. Abbott is a broad incumbent that competes with IntelliGenome on TB benchtop testing throughput and global lab market share.
- QIAGEN: QIAGEN offers QuantiFERON-TB Gold Plus and the QIAreach QuantiFERON-TB latent TB assay, plus sample-prep and PCR workflows used in TB labs. It is a broad incumbent in TB and molecular diagnostics that IntelliGenome's leadership has deep prior ties to and competes with across workflow stages.
- Roche Diagnostics: Roche's cobas MTB and cobas 6800/8800 systems are established high-throughput molecular TB diagnostics in central laboratories. Roche is a broad incumbent competing with IntelliGenome's CRISPR-TB Benchtop Assay for the same high-volume reference-lab TB testing market.
Emerging players
- Bioneer: Bioneer offers the AccuPower TB real-time PCR kit for molecular TB detection, with a focus on emerging markets. It is comparable to IntelliGenome as a regional/emerging molecular TB diagnostics player targeting cost-sensitive and decentralized settings.
- QuantuMDx: QuantuMDx is developing the Q-POC rapid molecular diagnostic platform for infectious diseases including TB at the point of care. It is an emerging POC molecular diagnostics peer with overlapping TB and decentralized-testing positioning to IntelliGenome's Lab-in-Tube.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
IntelliGenome social profiles
Digital presenceIntelliGenome compliance and trust
Trust signalCompliance4 records
IntelliGenome financial estimates
Financial estimateRevenue estimate
Valuation estimate
IntelliGenome leadership team
Management profileNumber of profiles
Profiles7 records
IntelliGenome subsidiaries and ownership
Company hierarchySubsidiaries1 record
IntelliGenome funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
IntelliGenome 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 IntelliGenome
What does IntelliGenome do?
IntelliGenome develops and commercializes CRISPR-based molecular diagnostic tests that detect pathogen cell-free DNA in blood samples, with the lead application being tuberculosis detection. The company offers a high-throughput CRISPR-TB Benchtop Assay for clinical laboratories and a portable CRISPR-TB Point of Care Blood Assay built on its proprietary Lab in Tube (LIT) platform. Research-stage offerings extend the platform to nontuberculous mycobacteria (NTM) detection and oncology cfDNA biomarker detection.
Is IntelliGenome a public or private company?
IntelliGenome is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was IntelliGenome founded?
IntelliGenome was founded in 2022. It employs 1 to 10 people.
Where is IntelliGenome based?
IntelliGenome is headquartered in Houston, United States, in the North America region.
How does IntelliGenome make money?
Three revenue lines are on record. CRISPR-TB Blood Test is the primary driver. The others are point-of-Care Testing Solutions and NIH-Funded R&D Collaboration.
Who are IntelliGenome's main competitors?
Direct peers on record are Sherlock Biosciences, Cepheid (Danaher), Molbio Diagnostics, Hain Lifescience (Bruker) and Mammoth Biosciences. Broad incumbents are Abbott, QIAGEN and Roche Diagnostics. Emerging players are Bioneer and QuantuMDx.
Does IntelliGenome have an API?
No public API is recorded for IntelliGenome.
What industry is IntelliGenome in?
IntelliGenome's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAHAAAD, Molecular Diagnostics (PCR/NAAT/NGS-based IVD), with a secondary code of HLAAALAA, Molecular Diagnostics (PCR/qPCR, NGS-based assays). Its NAICS code is 325413 and its SIC code is 2835.