Immuno-Mycologics, Inc.

What Immuno-Mycologics, Inc. does

Immuno-Mycologics, Inc. (IMMY) is a privately held biotechnology company founded in 1979 by Dr. Stan Bauman in Norman, Oklahoma, and controlled by the Bauman family across two generations. The company develops, manufactures, and distributes diagnostic tests and reagents for fungal diseases, organized across three technology platforms: Lateral Flow Assays (LFA), Enzyme Immunoassays (EIA), and Polymerase Chain Reaction (PCR), plus the MycoDDR specimen processing reagent line for mycobacteria culture work.

IMMY's product portfolio spans over 100 SKUs covering cryptococcosis (CrAg LFA, CrAg EIA), histoplasmosis (Histoplasma GM EIA), coccidioidomycosis (Coccidioides Antibody LFA and EIA), blastomycosis (Blastomyces Antibody EIA, the only commercially available kit for this indication), aspergillosis (Aspergillus Galactomannan LFA), candidiasis (AurisID for Candida auris surveillance, CandID for six Candida species), and Pneumocystis pneumonia (PneumID). Flagship CrAg LFA delivers results in 10 minutes and is WHO-recommended for cryptococcal meningitis screening in HIV-positive populations. Products hold FDA and/or CE clearance and are distributed in 80+ countries with multi-language documentation in nine languages.

IMMY generates revenue primarily through direct sales of diagnostic kits and reagents to clinical laboratories, hospitals, reference laboratories, public health agencies, and academic medical centers, complemented by a global distributor network. Pricing is quote-based with no public list pricing. The company sells through a sales-led, event-driven go-to-market model, leveraging participation in major mycology and infectious disease conferences (ISHAM, INTEREST, APACC, ICAN, TIMM, IDWeek) and direct website inquiries. Recent strategic expansion includes the May 2024 acquisition of OLM Diagnostics (UK), which added PCR-based molecular diagnostics to the portfolio and extended IMMY's first dedicated Latin America business unit and first global sales team.

Name

Immuno-Mycologics, Inc.

Legal name

Immuno-Mycologics, Inc.

Website

https://immy.com

Company type

Private

Founded year

1979

Operating status

Operating

Headcount range

101–250 employees

Short description

Immuno-Mycologics, Inc. (IMMY) is a privately held, family-owned fungal diagnostics company that develops, manufactures, and distributes lateral flow, EIA, and PCR-based diagnostic tests across 80+ countries. Founded in 1979 and headquartered in Norman, Oklahoma, it serves clinical labs, hospitals, and public health agencies worldwide.

Ownership category

akta.pro rank

Product category

Fungal Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC)

akta.pro secondary industries

Infectious Disease POCT (Respiratory, STI, HIV, Sepsis) (HLAHAOAA), Autoimmune, Allergy & Specialized Immunology Diagnostics (HLAHAAAK)

Keywords

• Fungal diagnostic tests
• Lateral flow assays
• Enzyme immunoassays
• Clinical microbiology reagents
• In vitro diagnostics

Headquarters

HQ city

Norman

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Tests and Reagents Sales: IMMY generates revenue through the sale of its diagnostic test kits and reagents across lateral flow, EIA, and PCR platforms, as well as mycobacteria processing reagents. Products are sold globally in over 80 countries through direct sales and distribution networks. Pricing is quote-based with no public list pricing.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels9 records

Core offering

Immuno-Mycologics, Inc. (IMMY) develops, manufactures, and distributes in vitro diagnostic test kits and reagents focused exclusively on fungal diseases, spanning three core technology platforms: Lateral Flow Assays (LFA), Enzyme Immunoassays (EIA), and Polymerase Chain Reaction (PCR), plus mycobacteria specimen processing reagents (MycoDDR). The portfolio includes rapid antigen/antibody detection tests for cryptococcosis, histoplasmosis, aspergillosis, coccidioidomycosis, blastomycosis, candidiasis, and Pneumocystis pneumonia, serving clinical laboratories, hospitals, and public health institutions in over 80 countries.

Product overview

IMMY offers a comprehensive portfolio of fungal diagnostic products organized into four main categories: Lateral Flow Assays (LFA) including CrAg LFA, Aspergillus GM LFA, and Coccidioides Antibody LFA for rapid point-of-care testing; Enzyme Immunoassays (EIA) including Histoplasma GM EIA, Cryptococcal Antigen EIA, Coccidioides Antibody EIA, and Blastomyces Antibody EIA for scalable laboratory testing; PCR tests including Candida auris PCR (AurisID), Candida Species PCR (CandID), and Pneumocystis jirovecii PCR (PneumID) for molecular detection; and Other Products including MycoDDR specimen processing, Latex Agglutination, Cleargel Immunodiffusion, and Complement Fixation reagents. Products are available with CE marking for international markets and FDA clearance for US markets.

Differentiator

Problem solved

Functional benefit

Brands

• IMMY: Primary brand name for Immuno-Mycologics, Inc. used across all products and communications.

Products and services

• CrAg LFA (Cryptococcal Antigen Lateral Flow Assay) Rapid lateral flow immunoassay for qualitative and semi-quantitative detection of cryptococcal antigen in whole blood, serum, plasma, and CSF. Results in 10 minutes with up to 200x higher analytical sensitivity than other commercial assays. For clinical laboratories and HIV/AIDS care programs.
• Aspergillus Galactomannan LFA Rapid lateral flow assay for detection of Aspergillus galactomannan antigen in serum and BAL specimens. Results in 45 minutes with 97% sensitivity in serum and 91% sensitivity in BAL for invasive aspergillosis. For hospital and reference laboratories.
• Coccidioides Antibody LFA (sōna) Rapid lateral flow assay for detection of anti-Coccidioides antibodies with IgG and IgM differentiation. Results in 30 minutes, reduces send-out testing costs. For clinical laboratories diagnosing Coccidioidomycosis (Valley Fever).
• Histoplasma Galactomannan EIA Enzyme immunoassay for detection of Histoplasma antigen in urine. Results in 2 hours 15 minutes, 96 patients per plate. FDA cleared and CE marked. For high-volume reference and hospital laboratories.
• Cryptococcal Antigen EIA Direct immunoenzymatic sandwich microplate assay for detection of cryptococcal antigen in serum and CSF. 192 tests per kit. Described as the most sensitive and specific EIA for cryptococcal antigen detection. For reference laboratories.
• Coccidioides Antibody EIA Enzyme immunoassay for detection of Coccidioides antibody in serum and CSF. Results in 2 hours, with two 96-well plates using different antigen preparations for enhanced sensitivity and specificity. Offers IgG and IgM differentiation. FDA cleared.
• Blastomyces Antibody EIA (Clarus) Enzyme immunoassay for detection of Blastomyces antibody. Results in 2 hours. The only commercially available diagnostic kit for detection of Blastomyces antibody. 96-well plate format. FDA cleared.
• AurisID (Candida auris Real-Time PCR) Real-Time PCR test for detection of Candida auris in serum, plasma, and surveillance swabs (axilla/groin, nasopharyngeal). Sensitive to less than 10 Candida auris genome copies. CE cleared. For infection control programs and public health laboratories.
• CandID (Candida Species Real-Time PCR) Real-Time PCR test for detection of six main Candida species (C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, C. dubliniensis, C. krusei) associated with invasive candidiasis. Sensitive to less than 1 Candida genome copy. CE cleared.
• PneumID (Pneumocystis jirovecii Real-Time PCR) Real-Time PCR test for detection of Pneumocystis jirovecii in respiratory wash and BAL specimens. Targets P. jirovecii and human β-globin gene (Endogenous Internal Control). Sensitive to less than 1 Pneumocystis genome copy. Results within 45 minutes. CE cleared.
• MycoDDR Trident Reliable processing system for digestion and decontamination of patient specimens for mycobacterium culture. Features rigid pH control using pH-indicating reagent system with Neutralization Buffer B and NALC combined with sodium hydroxide. Reduces lab tech variability, improves smear quality, and delivers culture results 1-7 days faster.
• Latex Agglutination Antibody or antigen detection systems that are semi-quantitative tests detecting agglutinating antibodies in patient serum for respective fungal diseases. Can aid in diagnosis. For clinical laboratories.
• Cleargel Immunodiffusion Proprietary gelling agent producing ultra-clear gel structure for easy visualization of precipitin bands in immunodiffusion testing, overcoming the inherently opaque appearance of standard agarose immunodiffusion plates.
• Complement Fixation Antigens and Controls Fungal antigens and positive controls used to detect antibodies in patient serum by the complement fixation procedure. For clinical laboratories performing complement fixation testing.

Quantifiable outcome

• CrAg LFA correctly generates positive results for 100% of patients with Cryptococcus in serum and CSF samples, and 98% in Plasma and Whole Blood; negative results for 100% of patients without Cryptococcus in serum, CSF, and Plasma, and 94% in Whole Blood
• +5 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature12 records

Partnerships

One partnership is on record.

• OLM DiagnosticscoreStrategic or Co-development Partner · 16 May 2024IMMY acquired OLM Diagnostics, a UK-based molecular diagnostic company, in May 2024 to expand its product portfolio and enhance capabilities in fungal diagnostics. The acquisition aims to leverage OLM's innovation and foster collaboration for better healthcare outcomes. OLM's product references (OLM2008 PneumID, OLM2007 CandID, OLM2010 AurisID) are incorporated into IMMY's PCR portfolio, indicating technology integration.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Meridian Bioscience (now part of Revvity): Meridian Bioscience, now under Revvity, manufactures the Meridian Cryptococcal Antigen EIA that IMMY's CrAg EIA directly competes against; both firms sell laboratory fungal diagnostics to clinical labs and reference centers globally.
• Associates of Cape Cod: Associates of Cape Cod developed the Fungitell (1→3)-β-D-glucan assay, a major fungal diagnostic competing with IMMY's Histoplasma Galactomannan EIA in invasive fungal infection screening for immunocompromised patients.
• Viracor Eurofins: Viracor (Eurofins) is a specialty reference lab and assay developer for fungal diagnostics including galactomannan and PCR-based tests; it overlaps IMMY's Histoplasma, Aspergillus, and Candida PCR portfolios.
• Bruker: Bruker's MALDI-TOF mass spectrometry systems (MBT) and fungal identification libraries compete with IMMY's molecular diagnostics for clinical mycology workflows in hospital and reference laboratories.
• MiraVista Diagnostics: MiraVista is a specialty clinical lab and developer of Histoplasma and Blastomyces antigen/antibody assays; it overlaps IMMY's Histoplasma GM EIA and Clarus Blastomyces EIA in the U.S. endemic mycoses market.

Emerging players

• T2 Biosystems: T2 Biosystems' T2Candida panel and T2Resistance are molecular diagnostics for invasive candidiasis, competing with IMMY's CandID PCR for early detection of bloodstream fungal infections.
• ELITechGroup: ELITechGroup is a specialty IVD company with microbiology and infectious-disease molecular panels (including aspergillus PCR) that overlap IMMY's PCR fungal franchise inherited from OLM Diagnostics.

Broad incumbents

• Bio-Rad Laboratories: Bio-Rad is a major clinical diagnostics incumbent with broad microbiology and infectious-disease IVD menus that include fungal serology and PCR kits competing against IMMY's specialized portfolio.
• QuidelOrtho: QuidelOrtho's specialty diagnostics include cryptococcal antigen latex agglutination and other infectious-disease tests that compete with IMMY's CrAg LFA and CrAg EIA in clinical labs.
• Abbott Diagnostics: Abbott's broad IVD and immunoassay platforms (including ARCHITECT) offer infectious-disease serology that can substitute for some of IMMY's EIA tests in high-volume reference laboratories.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/immydiagnostics
• Facebookfacebook.com/immy.diagnostics
• LinkedInlinkedin.com/company/immuno-mycologics-inc.

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Immuno-Mycologics, Inc.