HeaIgen Scientific
Developer and manufacturer of in‑vitro diagnostics (IVD) with a product portfolio spanning rapid point‑of‑care immunoassays, molecular diagnostics, toxicology, biochemistry and related testing solutions. Offers assay development, contract/private‑label manufacturing, regulatory support and global distribution. Operates a large‑scale POCT production facility and provides products for both clinical/point‑of‑care and over‑the‑counter at‑home use.
Industries
Nr. of Employees
small (1-50)
HeaIgen Scientific
330 Barker Cypress Rd, Suite 300, Houston, TX 77094
Products
At‑home combined SARS‑CoV‑2 and Influenza A/B rapid antigen test (OTC)
Lateral‑flow antigen test for qualitative detection and differentiation of SARS‑CoV‑2, influenza A and influenza B from anterior nasal swabs for over‑the‑counter home use (suitable for specified age groups).
Point‑of‑care COVID‑19/Influenza A/B antigen combo cassette (swab) for clinical/POC use
Lateral‑flow antigen cassette intended for use in CLIA‑certified point‑of‑care settings; authorized for Emergency Use where applicable and intended for symptomatic individuals within defined windows.
Rapid Strep A antigen test (throat swab)
Chromatographic immunoassay for qualitative detection of Group A Streptococcal antigen from throat swabs, intended to aid diagnosis with included external controls.
Toxicology rapid screening panels and residue tests
Rapid tests for detection of fentanyl, xylazine, multi‑drug urine panels, surface residue testing and drink‑spiking compounds with defined cutoffs and short time‑to‑result.
At‑home combined SARS‑CoV‑2 and Influenza A/B rapid antigen test (OTC)
Lateral‑flow antigen test for qualitative detection and differentiation of SARS‑CoV‑2, influenza A and influenza B from anterior nasal swabs for over‑the‑counter home use (suitable for specified age groups).
Point‑of‑care COVID‑19/Influenza A/B antigen combo cassette (swab) for clinical/POC use
Lateral‑flow antigen cassette intended for use in CLIA‑certified point‑of‑care settings; authorized for Emergency Use where applicable and intended for symptomatic individuals within defined windows.
Rapid Strep A antigen test (throat swab)
Chromatographic immunoassay for qualitative detection of Group A Streptococcal antigen from throat swabs, intended to aid diagnosis with included external controls.
Toxicology rapid screening panels and residue tests
Rapid tests for detection of fentanyl, xylazine, multi‑drug urine panels, surface residue testing and drink‑spiking compounds with defined cutoffs and short time‑to‑result.
Services
Collaborative assay and diagnostic product development from concept through validation and commercialization.
Manufacture and label diagnostic products for third‑party brands with regulatory and quality support.
Scalable production, warehouse and logistics support for pilot and full‑scale commercialization of diagnostics.
Regulatory strategy, documentation and submission support for FDA (EUA, 510(k), De Novo), CE and other markets.
Collaborative assay and diagnostic product development from concept through validation and commercialization.
Manufacture and label diagnostic products for third‑party brands with regulatory and quality support.
Scalable production, warehouse and logistics support for pilot and full‑scale commercialization of diagnostics.
Regulatory strategy, documentation and submission support for FDA (EUA, 510(k), De Novo), CE and other markets.
Expertise Areas
- Rapid point‑of‑care diagnostics
- Infectious disease testing (respiratory, blood‑borne, STI, tropical)
- Toxicology screening and residue detection
- Assay development and validation
Key Technologies
- Lateral‑flow immunoassays
- Fluorescent immunoassay (FIA) analyzers
- Western blot
- Dry chemistry biochemistry strips/systems
News & Updates
Exhibition and conference event participation.
Trade conference attendance.
Announcement of expanded online availability and note of FDA De Novo authorization for the first OTC combination COVID‑19/Flu A&B test.
Educational article discussing occult HBV infection and the role of serological and molecular approaches in screening.
First over‑the‑counter combined COVID‑19 and influenza A/B antigen test granted De Novo authorization by the U.S. FDA.
Reported global distribution of over 2 billion rapid COVID‑19 antigen self‑test kits across more than 80 countries.
Exhibition and conference event participation.
Trade conference attendance.
Announcement of expanded online availability and note of FDA De Novo authorization for the first OTC combination COVID‑19/Flu A&B test.
Educational article discussing occult HBV infection and the role of serological and molecular approaches in screening.
First over‑the‑counter combined COVID‑19 and influenza A/B antigen test granted De Novo authorization by the U.S. FDA.
Reported global distribution of over 2 billion rapid COVID‑19 antigen self‑test kits across more than 80 countries.