HeaIgen Scientific
- Company typePrivate
- Founded2007
- HeadquartersHouston, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
HeaIgen Scientific firmographics
Firmographics- Name
- HeaIgen Scientific
- Legal name
- Healgen
- Website
- https://healgen.us
- Company type
- Private
- Founded year
- 2007
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Ownership category
- akta.pro rank
HeaIgen Scientific industry classification
Industry- Product category
- In-vitro diagnostics (IVD)
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)
- akta.pro secondary industries
- Home Diagnostic & Self-Test OTC Kits (HLAIADAO), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)
Keywords
Where HeaIgen Scientific is headquartered
LocationHeadquarters
- HQ city
- Houston
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
HeaIgen Scientific business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Diagnostic Product Sales: Healgen generates revenue through the sale of rapid diagnostic test kits and devices, including FDA-cleared/authorized products for infectious diseases (COVID-19, Flu, Strep A), toxicology (fentanyl, multi-drug panels), and other clinical applications. Revenue is derived from one-time product transactions sold to healthcare providers, clinical laboratories, and consumers.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Contact sales for product pricing |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels3 records
HeaIgen Scientific product offering
Product offeringCore offering
Healgen Scientific develops, manufactures, and commercializes in-vitro diagnostic (IVD) rapid test systems spanning infectious disease (COVID-19, Flu A&B, Strep A), toxicology (multi-drug urine panels, fentanyl, xylazine), and consumer self-testing. The portfolio includes FDA 510(k)-cleared, De Novo-cleared, and CLIA-waived products sold to healthcare providers, clinical laboratories, toxicology screening programs, and individual consumers.
Product overview
Healgen is a leading global in-vitro diagnostics (IVD) developer and manufacturer offering a portfolio of rapid diagnostic tests. The company provides both CLIA-waived point-of-care tests and FDA-cleared over-the-counter products across several product families: the Accurate® line of multi-drug urine and oral fluid screening cups; the AccuFluor™ brand of fluorescent immunoassay tests; the Rapid Check® and Heal-Check lines for COVID-19 and respiratory disease testing; and specialty toxicology tests including fentanyl/xylazine and spiked drink detection. Healgen's products are designed for healthcare providers, workplaces, and consumers, addressing infectious diseases, toxicology/drug screening, and general health diagnostics.
Differentiator
Problem solved
Functional benefit
Brands
- Healgen AccuFluor: Fentanyl FIA Test Kit product line
- Rapid Check
- Accurate
- Heal-Check
Products and services
- Healgen AccuFluor Fentanyl FIA Test Kit CLIA-waived rapid fentanyl screening test kit using fluorescent immunoassay (FIA) technology, designed for point-of-care fentanyl detection without requiring high-complexity laboratory infrastructure. Targeted at healthcare providers, harm reduction programs, and clinical settings responding to the opioid crisis.
- Healgen Accurate Oral Fluid Device FDA 510(k) cleared oral fluid drug testing device enabling non-invasive sample collection for workplace and clinical drug screening applications. Designed for employers, treatment programs, and clinical screening workflows.
- Accurate Multi-Drug Urine Drug Screen Cup FDA 510(k) cleared and CLIA-waived professional-use multi-drug urine screening cup detecting 18 substances including fentanyl at 5 ng/mL cutoff (calibrated to Norfentanyl) in a single device for point-of-care drug screening.
- Accurate Home Multi-Drug Urine Test Cup FDA 510(k) cleared and CLIA-waived over-the-counter 18-in-1 multi-drug urine test cup for home use, providing consumers with comprehensive drug screening including fentanyl detection.
- Healgen Rapid Check COVID-19/Flu A&B Antigen Test FDA De Novo cleared combination rapid antigen test detecting COVID-19 and Influenza A&B from a single sample, designed for over-the-counter consumer self-testing for respiratory disease differentiation.
- Healgen Rapid Check COVID-19/Flu A&B Antigen Test Professional FDA 510(k) cleared professional-use point-of-care version of the combined COVID-19/Flu A&B antigen test, intended for healthcare providers, clinics, urgent care centers, and physician offices.
- Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) Rapid test cassette for simultaneous detection of COVID-19 and Influenza A&B antigens from a single nasal swab sample, used for respiratory disease differentiation in clinical and point-of-care settings.
- Heal-Check Rapid COVID-19 Antigen Self-Test FDA 510(k) cleared over-the-counter COVID-19 antigen self-test for at-home use, expanding consumer access to rapid COVID-19 screening without visiting a healthcare facility.
- Strep A Test Rapid diagnostic test for detection of Group A Streptococcus bacteria causing strep throat, used in physician offices, urgent care centers, and clinical settings.
- Fentanyl/Xylazine Residue Test Rapid dual-detection test for fentanyl and xylazine residues, addressing emerging drug threat concerns for harm reduction, first responders, and substance abuse programs.
- Spiked Drink Test Rapid consumer test designed to detect date rape drugs or spiked beverages, marketed for personal safety screening by individuals.
Quantifiable outcome
- Multi-panel drug detection including 18 substances with fentanyl sensitivity of 5 ng/mL calibrated to Norfentanyl
- +1 more outcomes
Companies that use HeaIgen Scientific
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles3 records
HeaIgen Scientific technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
HeaIgen Scientific partnerships and signals
Strategic signalScale indicators6 records
Recent moves6 records
Expansion highlights5 records
HeaIgen Scientific competitors and assessment
Company assessmentDirect peers
- Access Bio: Access Bio (CareStart COVID-19 and combo tests) is a direct peer in rapid antigen infectious disease diagnostics, with comparable professional and OTC channel strategies globally.
- ACON Laboratories: ACON Labs (Flowflex COVID-19 test, Mission Urine Drug Test Cups) is a close direct competitor in rapid antigen diagnostics and multi-panel urine drug screens with similar OTC and professional positioning.
- iHealth Labs: iHealth built a major position in OTC COVID-19 antigen self-tests and broader consumer diagnostics, competing head-to-head with Healgen's Heal-Check self-test and OTC drug screen offerings.
- Premier Biotech: Premier Biotech focuses on urine drug screening cups and oral fluid tests with FDA 510(k) clearances, closely mirroring Healgen's Accurate line in workplace and clinical toxicology.
- OraSure Technologies: OraSure pioneered oral fluid drug testing (Intercept) and rapid infectious disease diagnostics, directly comparable to Healgen's Accurate Oral Fluid Device and POC infectious disease portfolio.
- QuidelOrtho: QuidelOrtho markets QuickVue and Sofia rapid antigen tests (COVID-19, Flu, Strep A) — directly overlapping with Healgen's Rapid Check and Strep A products at point-of-care and OTC channels.
Broad incumbents
- Becton Dickinson (BD): BD's Veritor rapid antigen system and broader diagnostics portfolio compete with Healgen in POC infectious disease testing, while BD's drug-screening offerings overlap with Healgen's toxicology line.
- Roche Diagnostics: Roche offers rapid antigen tests (SARS-CoV-2, Influenza) plus a broad diagnostics portfolio, competing with Healgen in POC respiratory testing and providing large-incumbent benchmark.
- Siemens Healthineers: Siemens Healthineers (CLINITEST rapid antigen, broad lab diagnostics) is a broad incumbent competing with Healgen across POC infectious disease testing and laboratory diagnostics.
- Abbott Diagnostics: Abbott's Diagnostics division (BinaxNOW, ID NOW, m-PIMA) competes directly in rapid antigen infectious disease testing and offers a broad IVD portfolio across hospital and POC settings, vastly larger than Healgen.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights5 records
Customer concentration
HeaIgen Scientific social profiles
Digital presenceHeaIgen Scientific compliance and trust
Trust signalCompliance2 records
HeaIgen Scientific financial estimates
Financial estimateRevenue estimate
Valuation estimate
HeaIgen Scientific leadership team
Management profileNumber of profiles
Profiles1 record
HeaIgen Scientific funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
HeaIgen Scientific 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 HeaIgen Scientific
What does HeaIgen Scientific do?
Healgen Scientific develops, manufactures, and commercializes in-vitro diagnostic (IVD) rapid test systems spanning infectious disease (COVID-19, Flu A&B, Strep A), toxicology (multi-drug urine panels, fentanyl, xylazine), and consumer self-testing. The portfolio includes FDA 510(k)-cleared, De Novo-cleared, and CLIA-waived products sold to healthcare providers, clinical laboratories, toxicology screening programs, and individual consumers.
Is HeaIgen Scientific a public or private company?
HeaIgen Scientific is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was HeaIgen Scientific founded?
HeaIgen Scientific was founded in 2007. It employs 51 to 100 people.
Where is HeaIgen Scientific based?
HeaIgen Scientific is headquartered in Houston, United States, in the North America region.
How does HeaIgen Scientific make money?
One revenue line is on record: diagnostic Product Sales.
Who are HeaIgen Scientific's main competitors?
Direct peers on record are Access Bio, ACON Laboratories, iHealth Labs, Premier Biotech, OraSure Technologies and QuidelOrtho. Broad incumbents are Becton Dickinson (BD), Roche Diagnostics, Siemens Healthineers and Abbott Diagnostics.
Does HeaIgen Scientific have an API?
No public API is recorded for HeaIgen Scientific.
What industry is HeaIgen Scientific in?
HeaIgen Scientific's product category is In-vitro diagnostics (IVD). Its primary akta.pro industry code is HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument), with a secondary code of HLAIADAO, Home Diagnostic & Self-Test OTC Kits. Its NAICS code is 325413 and its SIC code is 2835.