SA Scientific

What SA Scientific does

SA Scientific Ltd. is a privately held manufacturer of rapid diagnostic tests and pathogen detection devices, founded in 1984 and headquartered in San Antonio, Texas. The company designs, develops, and manufactures One-Step rapid tests under the SAS™ brand, serving physicians' offices and clinical laboratories in the USA and exporting to over 40 countries worldwide through authorized sales distributors. The company is led by President Harbi A. Shadfan, Ph.D., who has overseen operations since founding.

The product portfolio spans lateral flow immunoassays using colloidal gold and fluorescent-based technologies, rapid molecular tests based on isothermal RT-PCR detection/amplification, and dedicated reader instruments (SAS Reader and SAS Reader 2) for automated interpretation of fluorescent and visual tests. Core clinical product lines include pregnancy/fertility tests (hCG in serum, urine, and strip formats), infectious disease tests (StrepAlert, RSVAlert, Rotavirus, Legionella, Adenovirus, HSV 1&2), and sickle cell screening. Adjacent lines cover veterinary diagnostics (canine heartworm antigen, Giardia, parvovirus, FSH, LH) and food pathogen detection (E. coli lateral flow). The company holds ISO 13485:2016 certification, FDA-approved facility status, USDA approval for veterinary products, CE Mark for Europe, CMDCAS for Canada, and MHLW approval for Japan. SA Scientific pioneered the first FDA-approved Adenovirus Conjunctivitis Rapid Diagnostic Test.

The business operates as a B2B product sales operation, selling diagnostic kits, supporting quality control materials, and reader instruments to healthcare practitioners, clinical laboratories, veterinary practices, food safety operators, and research/public health organizations. Distribution combines direct sales to U.S. healthcare providers with an authorized distributor network internationally. The company has not disclosed external funding, M&A activity, revenue, or ownership changes; it has remained privately held since founding, with no documented secondary transactions or recapitalizations.

Name

SA Scientific

Legal name

SA Scientific Ltd.

Website

https://sascientific.com

Company type

Private

Founded year

1984

Operating status

Operating

Headcount range

51–100 employees

Short description

SA Scientific is a privately held manufacturer of One-Step rapid diagnostic tests and pathogen detection devices, founded in 1984 and based in San Antonio, Texas. The company serves physicians' offices, clinical laboratories, veterinary practices, food safety operations, and public health organizations globally through direct sales and a 40+ country authorized distributor network.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostic Test Kits

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Point-of-Care & In-Clinic Diagnostics (Rapid Tests, Benchtop Analyzers) (HLAMADAI)

akta.pro secondary industries

Veterinary Microbiology & Infectious Disease Testing (Culture/PCR/Serology) (HLAMADAC), Veterinary POCT & Rapid Diagnostics (Animal health rapid tests) (HLAHAOAL), Laboratory & Point-of-Care Diagnostic Devices (Analyzers, Test Kits, Microscopy) (HLAMAFAI), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Rapid diagnostic tests
• Lateral flow assays
• Molecular diagnostics kits
• Veterinary diagnostic tests
• Food pathogen detection

Headquarters

HQ city

San Antonio

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Test Kit Sales: Sale of rapid diagnostic test kits and devices for clinical, veterinary, food pathogen, and environmental testing applications. Products include lateral flow tests, molecular tests, and related control sets.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

SA Scientific designs, develops, and manufactures One-Step rapid diagnostic test kits and pathogen detection devices for clinical laboratories, physicians' offices, veterinary practices, and food safety testing facilities. The portfolio uses colloidal gold lateral flow, fluorescent-based lateral flow, and isothermal RT-PCR molecular test technologies across pregnancy, infectious disease, veterinary, and food pathogen applications, complemented by dedicated reader instruments and quality control sets.

Product overview

SA Scientific is a manufacturer of rapid diagnostic tests and pathogen detection devices, serving clinical laboratories worldwide since 1984. The product portfolio consists of One-Step rapid tests for fertility and pregnancy, infectious diseases, and veterinary diagnostics. The core offerings include lateral flow immunoassay tests (colloidal gold and fluorescent-based technologies) and rapid molecular tests using isothermal RT-PCR. Key product lines include: Pregnancy (hCG) tests in various formats (Serum/Urine, Strip, Ultimate), respiratory tests (RSVAlert, Rotavirus), infectious disease tests (StrepAlert, Legionella, Adenovirus, HSV), non-infectious tests (Sickle Cell), veterinary tests (Canine Heartworm, Giardia, FSH, LH), and supporting quality control products (Serum Controls, Control Sets). The company also offers dedicated readers (SAS™ Reader) for automated fluorescent and visual test interpretation. Testing technologies include colloidal gold lateral flow, fluorescent-based lateral flow, and rapid molecular (isothermal RT-PCR) platforms.

Differentiator

Problem solved

Functional benefit

Brands

• SAS: SAS diagnostic tests including respiratory illness tests, molecular tests for food pathogens, and veterinary diagnostic tests
• SAS Reader
• SAS 2

Products and services

• Pregnancy (hCG) Serum/Urine Test Rapid membrane-based test detecting human chorionic gonadotropin (hCG) in serum or urine for pregnancy diagnosis, intended for clinical laboratories and physicians' offices. CLIA classification varies by specimen type (Serum: Non-waived, Urine: Waived).
• Pregnancy (hCG) Strip Rapid dipstick test detecting hCG in urine with results in 4 minutes, intended for point-of-care use in physicians' offices and clinical laboratories. CLIA Waived.
• Pregnancy (hCG) Ultimate Serum/Urine Test Enhanced sensitivity pregnancy test detecting hCG in serum or urine with results in 4 minutes (urine) or 5-8 minutes (serum), intended for clinical use where higher sensitivity is required.
• StrepAlert (Streptococcus Group A) Rapid test for detecting Streptococcus Group A from throat swabs with results in 5 minutes and sensitivity/specificity of 97.9%/97.3%, intended for physicians' offices and clinical laboratories.
• RSVAlert (Respiratory Syncytial Virus) Rapid detection of Respiratory Syncytial Virus from nasopharyngeal washes, aspirates, or swab specimens with results in 15 minutes and 97%/98% sensitivity/specificity, intended for clinical laboratories and healthcare providers.
• Rotavirus Test Rapid detection of rotavirus strains from stool specimens with results in 15 minutes and >98%/>98% sensitivity/specificity, intended for clinical laboratories and physician offices.
• Legionella Test Rapid detection of Legionella pneumophila from urine specimens for clinical diagnostic use in laboratories and healthcare settings.
• Adenovirus Test Rapid detection of adenovirus, including the pioneering FDA-approved Adenovirus Conjunctivitis Rapid Diagnostic Test - the first of its kind to receive FDA approval, intended for clinical diagnostic use.
• Sickle Cell Test Detection of Hemoglobin S in whole blood for sickle cell screening with results in 5-30 minutes and 99%/99% sensitivity/specificity, intended for clinical laboratory use.
• HSV 1 & 2 (Herpes Simplex Virus) Test Rapid test for detection of Herpes Simplex Virus types 1 and 2, intended for clinical laboratory and point-of-care diagnostic use.
• Giardia Antigen Test Rapid qualitative detection of Giardia lamblia cyst antigens in canine feces, intended for veterinary diagnostic use.
• Canine Heartworm Antigen Test Rapid detection of heartworm antigen in canine specimens, intended for veterinary clinics and animal health testing.
• Ovulation (LH) Test Detection of Luteinizing Hormone in urine for fertility tracking. Not FDA approved; for research use only.
• FSH (Follicle Stimulating Hormone) Test Detection of FSH in urine for fertility assessment. Not FDA approved; for research use only.
• Parvovirus Test Rapid test for Parvovirus detection, intended for veterinary diagnostic use.
• SAS Reader Instrument for Fluorescent and Visual Tests Reader instrument that automates interpretation of SA Scientific fluorescent and visual diagnostic tests, enabling high-sensitivity, standardized results for clinical laboratories and healthcare providers.
• SAS Reader 2 Instrument Second-generation reader instrument for SA Scientific fluorescent and visual diagnostic tests, intended for automated, high-sensitivity result interpretation in clinical laboratory settings.
• Quality Control Sets (Serum Ultimate Controls, Serum Controls, hCG Urine Controls, RSV, Rotavirus, Adenovirus, and Legionella Control Sets) Quality control materials used to verify performance of SA Scientific pregnancy, RSV, Rotavirus, Adenovirus, and Legionella diagnostic test kits, sold to clinical laboratories and healthcare providers as standalone control products.
• SAS Molecular Tests (Isothermal RT-PCR Kits) for Food Pathogens Rapid molecular diagnostic kits based on isothermal RT-PCR detection/amplification for food pathogen testing and public health applications, including lateral flow E. coli testing kits, intended for food safety laboratories and research institutions.

Quantifiable outcome

• Sensitivity/Specificity: 97%/98% for RSVAlert tests
• +4 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Authorized Sales DistributorscoreChannel Partner/ Reseller/ DistributorSA Scientific partners with authorized sales distributors globally to sell and distribute SAS diagnostic products. These distributors are contractually bound to use personal information only to perform services and do not rent or sell customer data for marketing purposes.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Sekisui Diagnostics: Sekisui Diagnostics develops and manufactures rapid diagnostic tests (including OSOM branded products) used in clinical and point-of-care settings. Directly comparable rapid lateral flow infectious-disease product portfolio.
• Meridian Bioscience: Meridian develops and manufactures lateral flow rapid diagnostic tests for infectious disease and other clinical applications. Comparable product categories (RSV, Strep, pregnancy), US manufacturing base, and similar OEM/OEM-style distribution model.
• Trinity Biotech: Trinity Biotech manufactures clinical diagnostic tests including lateral flow and immunoassay products with a focus on infectious disease and specialty testing. Comparable product mix and channel-to-clinical-laboratory distribution model.
• Princeton BioMeditech Corporation: Princeton BioMeditech develops rapid immunodiagnostic tests and hosts OEM manufacturing for multiple rapid test manufacturers (including SA Scientific-like OEM partners). Direct overlap in lateral flow infectious disease and pregnancy test OEM relationships.
• QuidelOrtho: QuidelOrtho operates the Sofia rapid diagnostic platform for respiratory, infectious, and other immunoassays with FDA-approved products sold to US clinicians. Direct overlap in rapid membrane-based immunoassay products targeting CLIA-waived point-of-care settings.

Broad incumbents

• Cepheid (Danaher): Cepheid operates the GeneXpert molecular diagnostics platform used in clinical, public health, and food safety testing — directly comparable to SA Scientific's isothermal RT-PCR kits entering research, food testing, and public health markets.
• bioMérieux: bioMérieux develops diagnostic solutions for clinical and industrial (food) microbiology markets. Overlaps with SA Scientific on food pathogen testing and respiratory infectious-disease diagnostics through different platforms (culture, PCR, immunoassay).
• Zoetis: Zoetis is the global leader in animal health diagnostics, including lateral flow and reference-lab veterinary products. Overlaps with SA Scientific's veterinary product line (Canine Heartworm, Giardia, Parvovirus), but operates at much greater scale across companion and livestock animal health.
• Abbott (Diagnostics / Alere legacy): Abbott operates the Binax and other rapid diagnostic product lines globally, including the legacy Alere rapid diagnostics franchise. Overlaps in lateral flow respiratory and infectious-disease testing but with materially larger portfolio, R&D, and channel.
• Becton Dickinson (BD): BD offers the BD Veritor™ rapid diagnostic system alongside a vast portfolio of medical devices. Overlaps with SA Scientific in respiratory and infectious-disease point-of-care testing but operates at vastly greater scale with broader diagnostics category coverage.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 SA Scientific