Invivoscribe, Inc.
Invivoscribe is a privately held precision diagnostics company founded in 1995 that develops NGS assays, companion diagnostics, and bioinformatics software for hematologic malignancies. It serves pharmaceutical partners and clinical laboratories across 160+ countries via its LabPMM clinical lab network.
- Company typePrivate
- Founded1995
- HeadquartersSan Diego, United States
- Headcount101–250
- GTM typeB2B
- OfferingHardware or Manufacturing
What Invivoscribe, Inc. does
Invivoscribe is a privately held, San Diego-based precision diagnostics company founded in 1995, focused on hematology-oncology. The company develops and commercializes next-generation sequencing (NGS) assays, companion diagnostics (CDx), measurable residual disease (MRD) testing kits, and proprietary bioinformatics software used by pharmaceutical developers and clinical laboratories worldwide. Its product portfolio spans gene-rearrangement assays (IdentiClone), FLT3 mutation testing (LeukoStrat CDx), KMT2A-rearrangement assays, and the recently launched PrepQuant sample-preparation system, supported by an automated analysis pipeline built around its LymphoTrack bioinformatics platform.
The company operates through three integrated business lines: (1) pharma-sponsored companion-diagnostic development and clinical-trial services anchored by named partners including Astellas, Daiichi Sankyo, Novartis, and Kronos Bio; (2) IVDR- and FDA-cleared assay and software kits sold to research and clinical laboratories across 160+ countries; and (3) clinical testing services delivered through its LabPMM laboratory network in the United States, Germany, and Japan on a fee-for-service basis. Regionally, the company is structured around wholly owned subsidiaries in France and China, with an active footprint in Shanghai and an expanding Japan operation under recently appointed general-management leadership.
Recent regulatory and product milestones include IVDR Class C certification for the IdentiClone Dx IGH Assay (March 2026), launch of the LeukoStrat KMT2A + MRD Assay (February 2026), launch of the PrepQuant System (April 2026), and ongoing registration submissions in the United Kingdom, Switzerland, and China. Strategic partnerships with Hitachi High-Tech (automation, 2022) and Complete Genomics (sequencing platform, 2023) extend the company's reach into sample-prep automation and into lower-cost sequencing for the China market.
Invivoscribe, Inc. firmographics
Firmographics- Name
- Invivoscribe, Inc.
- Legal name
- Invivoscribe, Inc.
- Website
- https://invivoscribe.com
- Company type
- Private
- Founded year
- 1995
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Invivoscribe is a privately held precision diagnostics company founded in 1995 that develops NGS assays, companion diagnostics, and bioinformatics software for hematologic malignancies. It serves pharmaceutical partners and clinical laboratories across 160+ countries via its LabPMM clinical lab network.
- Ownership category
- akta.pro rank
Invivoscribe, Inc. industry classification
Industry- Product category
- Molecular Diagnostics for Hematologic Malignancies
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (62151), Scientific Research and Development Services (5417)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB)
- akta.pro secondary industries
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)
Keywords
Where Invivoscribe, Inc. is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Invivoscribe, Inc. business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain
Revenue model
- Assay Kits and Reagents Sales: Sale of standardized cGMP manufactured diagnostic assay kits (RUO, CE-IVDR, IVD), analyte specific reagents (ASRs), and DNA/RNA controls to clinical laboratories and research institutions worldwide.
- Clinical Laboratory Testing Services (LabPMM): Fee-for-service clinical lab testing through the LabPMM network providing internationally standardized testing of biomarkers for hematologic malignancies including flow cytometry, NGS panels, MRD testing, and clonality testing.
- Companion Diagnostic Development Partnerships: Co-development and regulatory partnership revenue from pharmaceutical companies for CDx development, validation, and approval for targeted therapies. Includes CDx testing services supporting clinical trials.
- Bioinformatics Software Licensing: Licensing of LymphoTrack software (desktop, enterprise, MRD variants) and LeukoStrat software for NGS data analysis and MRD tracking.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Assay kits and reagents (RUO, IVD, CE-IVDR) |
Go-to-market motion2 records
Distribution channels4 records
Marketing channels6 records
Invivoscribe, Inc. product offering
Product offeringCore offering
Invivoscribe develops, manufactures, and commercializes cGMP precision diagnostic assay kits, bioinformatics software, and clinical laboratory services for hematologic malignancies, with a focus on companion diagnostics (CDx), clonality testing, and minimal residual disease (MRD) monitoring. Its flagship LeukoStrat CDx FLT3 Mutation Assay was the world's first FDA-approved companion diagnostic for AML and is approved for multiple targeted therapies across the USA, EU, Japan, and the UK. The company also operates the LabPMM global clinical laboratory network providing internationally standardized biomarker testing for patient care and pharmaceutical clinical trials.
Product overview
Invivoscribe is a global biotechnology company specializing in precision diagnostics for hematology-oncology with over 30 years of experience. The company offers a comprehensive portfolio of products organized around several core platforms: (1) LymphoTrack Solutions - a suite of NGS assays and bioinformatics software for clonality, somatic hypermutation, and MRD testing; (2) LeukoStrat CDx FLT3 Mutation Assay - a globally standardized companion diagnostic approved for three drugs across US, EU, and Japan markets; (3) PrepQuant System - an automated sample preparation platform developed with Hitachi High-Tech Corporation for nucleic acid extraction and quantification; and (4) LabPMM clinical laboratory services - an internationally standardized testing network with labs in USA, Germany, and Japan. The product portfolio also includes digital PCR-based assays (LeukoStrat KMT2A + MRD Assay), PCR-based IVD assays (IdentiClone Dx IGH Assay), and targeted gene panels (MyAML, MyMRD). The company provides CE-marked IVDs, RUO assays, ASRs, and controls/reagents for the hematology-oncology diagnostics market.
Differentiator
Problem solved
Functional benefit
Brands
- LymphoTrack: NGS-based clonality and MRD testing assays and software for B- and T-cell receptor gene rearrangement analysis
- LeukoStrat
- IdentiClone
- PrepQuant
- MyAML
- MyMRD
- LymphoQuant
- LymphoTrack Dx
Products and services
- LymphoTrack Solutions
Quantifiable outcome
- MRD detection sensitivity down to 0.005% (5×10⁻⁵) with digital PCR-based LeukoStrat KMT2A + MRD Assay, surpassing traditional cytogenetics and FISH methods
- +2 more outcomes
Companies that use Invivoscribe, Inc.
Customer profileNamed customers8 records
Segments4 records
Ideal customer profiles4 records
Invivoscribe, Inc. technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration3 records
AI capability3 records
Feature6 records
Invivoscribe, Inc. partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and major.
- Complete Genomics (BGI)corePartnership to develop and commercialize biomarker tests for oncology and cancer research. Enables Invivoscribe's LymphoTrack assays and LeukoStrat MRD assays to run on Complete Genomics' DNBSEQ-G99 sequencing platform, expanding platform compatibility for customers. Jointly published performance comparison white papers demonstrating assay equivalency between DNBSEQ-G99 and Illumina MiSeq platforms.
- Kronos BiomajorCompanion diagnostic development partnership for use with entospletinib, Kronos Bio's investigational compound being developed for patients with AML. Invivoscribe developing CDx to identify appropriate patient populations for the therapeutic candidate.
- Hitachi High-Tech CorporationcoreStrategic collaboration to develop and commercialize molecular diagnostic products. Jointly developed the PrepQuant System, an automated sample preparation platform integrating nucleic acid extraction, concentration, and quantification. First commercial shipments targeted for August 2026 in North America and January 2027 in Europe. The partnership combines Hitachi High-Tech's automation expertise with Invivoscribe's molecular diagnostics capabilities.
- Astellas PharmacoreCDx partnership for XOSPATA (gilteritinib fumarate) for FLT3-mutated AML. LeukoStrat CDx FLT3 Mutation Assay received FDA approval as companion diagnostic and national reimbursement in Japan. European Commission approved the therapy with validated tests including Invivoscribe's assay.
- Daiichi SankyocoreCDx partnership for VANFLYTA (quizartinib) for FLT3-ITD AML. LeukoStrat CDx FLT3 Mutation Assay received MHLW approval in Japan and EMA/EU approval for VANFLYTA therapy. Assay expanded to include specimens collected in EDTA. Submission to NMPA in China for regulatory approval.
- NovartiscoreCDx partnership for Rydapt (midostaurin) for newly diagnosed FLT3-mutated AML. The LeukoStrat CDx FLT3 Mutation Assay was the world's first FDA-approved companion diagnostic for AML, enabling patient selection for Novartis therapy. Invivoscribe received national reimbursement for the CDx assay in Japan.
- IlluminacoreLong-term collaboration agreement for development and release of NGS-based IVD assay kits. Invivoscribe develops LymphoTrack assays compatible with Illumina sequencing platforms (MiSeq, MiSeq i100, NextSeq 1000/2000) using proprietary adapters and tracking tags. Includes co-marketing and co-development of NGS-based diagnostic solutions.
- Thermo Fisher ScientificmajorLong-term collaboration to develop and commercialize immuno-oncology tests. LymphoTrack assays validated on Thermo Fisher Ion S5 and Ion PGM NGS platforms, expanding customer access to Invivoscribe's molecular diagnostics portfolio through Thermo Fisher's installed base.
Scale indicators4 records
Recent moves8 records
Expansion highlights5 records
Invivoscribe, Inc. competitors and assessment
Company assessmentDirect peers
- NeoGenomics Laboratories: Specialized oncology reference lab offering hematologic malignancy testing, MRD assays, and CDx services in the US and internationally. Direct competitor to Invivoscribe's LabPMM clinical lab and CDx franchise with significant overlap in lymphoma/leukemia molecular diagnostics.
- Adaptive Biotechnologies: ClonoSEQ MRD assay and immunoSEQ clonality platform overlap directly with Invivoscribe's LymphoTrack and LeukoStrat MRD products for blood cancer MRD monitoring. Both companies use NGS-based receptor gene sequencing for clonal tracking.
- Personalis: Cancer genomics company offering tumor profiling and MRD solutions (NeXT Personal) for biopharma and clinical use; competes with Invivoscribe's NGS panel/CDx/molecular diagnostic offering in oncology biomarker work.
- Asuragen (Bio-Techne): Molecular diagnostics business of Bio-Techne that develops quantitative PCR kits (e.g., BCR-ABL, JAK2) for blood cancer monitoring with pharma CDx experience; competes with Invivoscribe's PCR-based IdentiClone, LeukoStrat, and quantitative oncology kits.
Broad incumbents
- Foundation Medicine (Roche): Broad oncology NGS profiling and CDx developer owned by Roche; competes with Invivoscribe for biopharma CDx partnerships and hematologic panel testing, especially with its heme panel and global pharma services reach.
- QIAGEN: Major molecular diagnostics and sample technologies company with companion diagnostic, IVD assay, and bioinformatics offerings; broad incumbent competing with Invivoscribe's assay kits, CDx, and bioinformatics software businesses.
- Labcorp / Invitae (Archer): Labcorp acquired sequencing-based diagnostics and CDx assets including ArcherDX for hematologic fusion/mutation detection and inherited cancer testing; competes broadly with Invivoscribe's oncology NGS and CDx services through its central lab network.
- Sysmex Corporation: Global hematology diagnostics leader with cell analyzers, flow cytometry, and growing molecular hemato-oncology franchise; broad incumbent in hematologic malignancy diagnostics overlapping Invivoscribe's LabPMM flow and NGS services.
Emerging players
- Guardant Health: Liquid biopsy oncology testing and CDx company; while initially focused on solid tumors, expansion into blood-based cancer monitoring overlaps with Invivoscribe's hematologic MRD ambitions and CDx/biopharma partnership model.
- HTG Molecular Diagnostics (now part of standard bio-tools): Molecular profiling company developing tissue and blood-based oncology biomarker assays and CDx partnerships for hematologic and solid tumor indications; an emerging peer in biomarker-driven CDx development similar to Invivoscribe.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Invivoscribe, Inc. social profiles
Digital presenceInvivoscribe, Inc. compliance and trust
Trust signalCompliance7 records
Invivoscribe, Inc. financial estimates
Financial estimateRevenue estimate
Valuation estimate
Invivoscribe, Inc. leadership team
Management profileNumber of profiles
Profiles3 records
Invivoscribe, Inc. subsidiaries and ownership
Company hierarchySubsidiaries3 records
Invivoscribe, Inc. funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Invivoscribe, Inc. 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 Invivoscribe, Inc.
What does Invivoscribe, Inc. do?
Invivoscribe develops, manufactures, and commercializes cGMP precision diagnostic assay kits, bioinformatics software, and clinical laboratory services for hematologic malignancies, with a focus on companion diagnostics (CDx), clonality testing, and minimal residual disease (MRD) monitoring. Its flagship LeukoStrat CDx FLT3 Mutation Assay was the world's first FDA-approved companion diagnostic for AML and is approved for multiple targeted therapies across the USA, EU, Japan, and the UK. The company also operates the LabPMM global clinical laboratory network providing internationally standardized biomarker testing for patient care and pharmaceutical clinical trials.
Is Invivoscribe, Inc. a public or private company?
Invivoscribe, Inc. is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Invivoscribe, Inc. founded?
Invivoscribe, Inc. was founded in 1995. It employs 101 to 250 people.
Where is Invivoscribe, Inc. based?
Invivoscribe, Inc. is headquartered in San Diego, United States, in the North America region.
How does Invivoscribe, Inc. make money?
Four revenue lines are on record. Assay Kits and Reagents Sales are the primary driver. The others are clinical Laboratory Testing Services (LabPMM), companion Diagnostic Development Partnerships and bioinformatics Software Licensing.
Who are Invivoscribe, Inc.'s main competitors?
Direct peers on record are NeoGenomics Laboratories, Adaptive Biotechnologies, Personalis and Asuragen (Bio-Techne). Broad incumbents are Foundation Medicine (Roche), QIAGEN, Labcorp / Invitae (Archer) and Sysmex Corporation. Emerging players are Guardant Health and HTG Molecular Diagnostics (now part of standard bio-tools).
Does Invivoscribe, Inc. have an API?
No public API is recorded for Invivoscribe, Inc..
What industry is Invivoscribe, Inc. in?
Invivoscribe, Inc.'s product category is Molecular Diagnostics for Hematologic Malignancies. Its primary akta.pro industry code is HLAAAMAB, Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy), with a secondary code of HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 325413 and its SIC code is 2835.