Longhorn Vaccines & Diagnostics

Name

Longhorn Vaccines & Diagnostics

Legal name

Longhorn Vaccines and Diagnostics, LLC

Website

https://lhnvd.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Vaccine Fill-Finish, Packaging & Cold-Chain Formulation (vial/syringe, lyophilization, thermostable) (HLAAAEAJ)

akta.pro secondary industries

Vaccine Cold Chain, Storage & Distribution (HLAIAEAK), Pandemic Preparedness & Rapid-Response Vaccines (HLAIAEAF), Infectious Disease & Pandemic Preparedness Vaccines (emerging pathogens) (HLAAAEAC), Vaccine Technology Platforms (mRNA, viral vector, protein subunit, inactivated/live-attenuated, VLP, DNA) (HLAAAEAD), Vaccine Technology Platforms (Live, Inactivated, Subunit, Vector, mRNA/DNA) (HLAMAKAH)

Keywords

• Molecular transport media
• Pathogen inactivation reagents
• Tuberculosis diagnostic kits
• Composite peptide vaccines
• Monoclonal antibody development

Headquarters

HQ city

Bethesda

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Product Sales: Sale of PrimeStore MTM and related diagnostic products (PrimeScreen MTB, PrimeSeqMDR, PrimeXtract, PrimeMix, Salorn STM). Revenue from direct government/institutional procurement and through channel distributors. Primarily one-time product revenue with repeat orders from established customers.
2. Vaccine and Monoclonal Antibody Development: Longhorn is developing a portfolio of vaccines (LHNVD-105 universal influenza, LHNVD-301 TB vaccine, LHNVD-303 bacterial sepsis vaccine) and monoclonal antibodies (LHNVD-501 anti-bacterial mAb). These pipeline products represent future revenue potential through licensing or commercialization upon regulatory approval.

Pricing tiers

Go-to-market motion2 records

Distribution channels6 records

Marketing channels5 records

Core offering

Longhorn Vaccines & Diagnostics develops, manufactures, and commercializes PrimeStore MTM, the original FDA-cleared Molecular Transport Medium that simultaneously inactivates pathogens and stabilizes RNA/DNA for molecular testing without cold chain requirements. The company sells a portfolio of diagnostic reagent kits (PrimeScreen MTB, PrimeSeqMDR, PrimeXtract, PrimeMix TB/PrimeMix Flu, Salorn STM, PrimeStore ATM) for human and veterinary infectious disease surveillance, and operates a vaccine and monoclonal antibody pipeline targeting sepsis, antimicrobial resistance, and universal influenza.

Product overview

Longhorn Vaccines & Diagnostics is a One Health company developing a portfolio of diagnostic tools and vaccine/antibody products. The diagnostic portfolio centers on PrimeStore MTM, the original FDA-cleared Molecular Transport Media that inactivates pathogens and stabilizes RNA/DNA. This core product is complemented by a suite of TB-specific solutions under the PrimeSuite TB brand (PrimeScreen MTB, PrimeSeqMDR, PrimeXtract, PrimeMix TB/PrimeMix Flu) and newer products like PrimeStore ATM. The therapeutic pipeline includes monoclonal antibodies (LHNVD-501, DRG5-BD11) and composite peptide vaccines (LHNVD-303, LHNVD-105, LHNVD-110) targeting bacterial infections, sepsis, and influenza.

Differentiator

Problem solved

Functional benefit

Products and services

• PrimeStore MTM The original FDA-cleared (De Novo) Molecular Transport Medium that simultaneously inactivates pathogens (lysing organisms and destroying nucleases within seconds of sample insertion) and stabilizes RNA/DNA at ambient temperatures for 30+ days at 40°C. Intended for stabilization, transportation, and inactivation of nasal washes containing Influenza A virus RNA and sputum samples containing Mycobacterium tuberculosis DNA; sold to government agencies, clinical labs, and veterinary labs.
• PrimeStore ATM Ambient Temperature Molecular product that eliminates the need for RNA and DNA extraction in molecular testing workflows. Validated for flu tests and designed to streamline COVID-19 testing processes, sold to clinical labs and government agencies seeking higher-throughput molecular testing.
• Salorn STM Patent-pending, virucidal, bacteriostatic, Guanidine-free sample collection device that enables highly sensitive antigen testing capabilities. Not FDA cleared; company accepting orders for research use only.
• PrimeScreen MTB Tuberculosis triage oral screening kit that detects MTB DNA in the oral cavity for further diagnostic and clinical evaluation, enabling sputum-free TB molecular screening that requires no containment facilities for safe handling. Not for sale in the United States; clinically validated on over 1,000 individuals across three continents.
• PrimeSeqMDR Targeted gene sequencing kit for rapid screening of drug resistance-conferring mutations in MTB genes (rpoB, katG, gyrA, pncA) using a targeted amplification approach compatible with Illumina NGS. Generates amplicons of desired length without size-selection, circumventing expensive NGS library prep workflows. Not for sale or use in the United States.
• PrimeXtract Simplified total nucleic acid extraction system using silica-based spin column extraction for sensitive purification of RNA/DNA from samples, for downstream PCR, real-time PCR, and Next-Generation Sequencing workflows.
• PrimeMix TB Highly sensitive, tuberculosis-specific, all-inclusive PCR reagent mixture. Reduces costly labor-intensive preparation, is easy to use, and is stable for weeks at room temperatures.
• PrimeMix Flu PCR reagent mixture with primers and probes for influenza A. Authorized by FDA for Emergency Use during the H1N1 2009 Pandemic.

Quantifiable outcome

• 35 million+ PrimeStore MTM tubes distributed globally since COVID-19 pandemic began
• +4 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration10 records

Feature7 records

Partnerships

13 partnerships are on record, tiered core, major and minor.

• PromegacoreTechnology or Integration · 28 July 2025Longhorn Vaccines and Diagnostics partnered with Promega to combine complementary offerings for enhanced sample collection, transport, and analysis. Collaboration combines Promega's reagent systems with Longhorn's PrimeStore MTM for integrated molecular diagnostics workflows.
• IRTA-CReSA (Institute of Agrifood Research and Technology)coreStrategic or Co-development Partner · 25 September 2024Longhorn collaborated with IRTA-CReSA scientists and the World Organization of Animal Health (WOAH) Reference Laboratory for Classical Swine Fever to demonstrate effective inactivation of classical swine fever virus (CSFV) in laboratory and clinical samples using PrimeStore MTM. Results were presented at the Epizone Conference in Uppsala, Sweden, September 2024.
• DHL Global ForwardingcoreChannel Partner/ Reseller/ Distributor · 24 February 2021DHL Global Forwarding serves as Longhorn's logistics partner for international distribution, transporting PrimeStore MTM vials globally. DHL transported nearly 26,000 vials to Kenya, Nepal, and the Philippines for the IOM donation program, navigating complex cross-border logistics and customs requirements.
• International Organization for Migration (IOM)majorChannel Partner/ Reseller/ Distributor · 24 February 2021Recipient of Longhorn's donation of 1 million PrimeStore MTM tubes for COVID-19 testing of refugees and displaced persons in Kenya, Nepal, and the Philippines. DHL Global Forwarding handled the international logistics of this donation program.
• Greenfield Global / PharmcocoreChannel Partner/ Reseller/ Distributor · 15 June 2020Longhorn selected Greenfield Global's Pharmco brand high-purity reagent alcohol as a key ingredient/component for PrimeStore MTM. Pharmco supplies GMP-compliant, ISO 9001:2015-certified solvents enabling Longhorn to scale global distribution of PrimeStore MTM.
• Cenetron DiagnosticscoreChannel Partner/ Reseller/ Distributor · 1 June 2020Cenetron Diagnostics serves as Longhorn's contract manufacturer for PrimeStore MTM. Acquired by Versiti in 2019. Cenetron increased production capacity from 30L to 1600L per week and added additional filling shifts. Versiti opened an additional site to further meet demand.
• Coca-Cola Consolidated / Southeastern ContainercoreChannel Partner/ Reseller/ Distributor · 1 June 2020Southeastern Container, a Coca-Cola bottler cooperative, produces test tubes for COVID-19 testing kits using Longhorn's PrimeStore MTM. Can produce over 7 million preform tubes per week. Oak Ridge National Laboratory facilitated the collaboration to address a supply chain gap for test collection tubes.
• Sandia National LaboratoriesminorStrategic or Co-development Partner · 1 June 2020Sandia National Laboratories developed gamma irradiation sterilization protocols for the Coca-Cola preform tubes used with PrimeStore MTM, enabling medical-grade sterilization without damaging the plastic components.
• VMRDcoreChannel Partner/ Reseller/ Distributor · 19 May 2020VMRD became the distributor of Longhorn's PrimeStore MTM to the veterinary market. VMRD develops and manufactures veterinary diagnostic test kits distributed in more than 77 countries. PrimeStore MTM was tested by USDA and top veterinary diagnostic laboratories against high-consequence pathogens (ASFv, CSFv, FMDv, HPAI, NDv).
• Oak Ridge National Laboratory (ORNL)majorStrategic or Co-development Partner · 2 March 2020ORNL facilitated the partnership between Longhorn and Coca-Cola Consolidated to produce test tubes for COVID-19 testing kits. ORNL tested preforms for leak-proof performance and compatibility with PrimeStore MTM systems.
• BARDA / COVID-19 MCM Task ForcemajorStrategic or Co-development Partner · 1 January 2020The Biomedical Advanced Research and Development Authority (BARDA) and COVID-19 MCM Task Force reviewed an application to add PrimeStore MTM to the national stockpile for COVID-19 response and future outbreaks/pandemics.
• University of Pretoria (South Africa)minorStrategic or Co-development PartnerAcademic research collaboration on PrimeStore MTM utility for TB detection using Cepheid GeneXpert assay. Published study in International Journal of Tuberculosis and Lung Disease.
• Anova Health Institute (South Africa)minorStrategic or Co-development PartnerAcademic research collaboration on PrimeStore MTM for TB detection. Study included researchers from South Africa, City of Milwaukee Health Department Laboratory, and University of Texas at San Antonio.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Hologic: Hologic's Panther and Aptima molecular diagnostics systems serve clinical labs for infectious disease testing, including TB and women's health — overlapping customer base and competing for the same sample-to-answer workflow budgets.
• Cepheid (Danaher): Cepheid's GeneXpert MTB/RIF system is the principal installed-base platform that PrimeStore MTM is validated against — and is therefore both a critical compatibility partner and a potential competitor with proprietary sample-prep workflows.
• Qiagen: Qiagen is a global leader in sample preparation technologies for molecular diagnostics, including transport media and extraction kits directly compatible with PrimeStore MTM. As a platform incumbent with far greater scale and product breadth, Qiagen represents the dominant upstream/downstream player in Longhorn's workflow.
• Thermo Fisher Scientific: Thermo Fisher provides the Applied Biosystems 7500 PCR platform and Ion Torrent NGS system against which PrimeStore MTM and PrimeSeqMDR are validated. As a vertically integrated diagnostics incumbent, it could bundle alternative sample-prep solutions into its installed base.
• Becton Dickinson (BD): BD manufactures viral transport media and a full portfolio of molecular diagnostics and sample-prep consumables. Longhorn's PrimeStore MTM competes for the same hospital and government lab budgets as BD's transport media products.
• bioMérieux: bioMérieux offers molecular diagnostics extraction systems and reagents compatible with PrimeStore MTM, and operates broadly in infectious disease diagnostics including TB and pandemic preparedness — overlapping customer segments.

Direct peers

• Hardy Diagnostics: Hardy Diagnostics produces a range of viral and bacterial transport media used in clinical microbiology labs. They compete with Longhorn in the ambient-temperature sample transport category for clinical and reference laboratory customers.
• Copan Diagnostics: Copan manufactures the Universal Transport Medium (UTM), the most direct competitor to PrimeStore MTM in the molecular sample collection/transport category. Both companies sell FDA-cleared transport media used with downstream PCR platforms across clinical, research, and government customers.

Emerging players

• Meridian Bioscience: Meridian develops and manufactures diagnostic test kits and reagents for infectious disease detection, including sample-prep and molecular assay reagents that compete for the same clinical and government procurement dollars as Longhorn's PrimeMix and PrimeSeq product lines.
• Promega: Promega signed a 2025 partnership with Longhorn to combine reagent systems with PrimeStore MTM for integrated sample collection, transport, and analysis workflows. As a reagent/kit developer with deep molecular biology expertise, Promega is both a partner and a potential source of integrated competitive offerings.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/longhorn-vaccines-and-diagnostics-llc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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 Longhorn Vaccines & Diagnostics