TestCountry
Confirm Biosciences (TestCountry) is a San Diego-based OTC diagnostics manufacturer of at-home drug-of-abuse, infectious disease, and women's health tests, selling branded and private-label products through 20,000+ US retail locations and direct enterprise and government channels.
- Company typePrivate
- Founded2001
- HeadquartersSan Diego, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What TestCountry does
Confirm Biosciences (operating as the firmographic entity TestCountry) is a San Diego-based medical device and OTC diagnostics company founded in 2001. It designs and manufactures at-home rapid diagnostic tests across three categories: drugs of abuse (including fentanyl), infectious diseases (notably COVID-19/Flu A&B antigen), and women's health (pregnancy, UTI/pH, vaginal health screening). The company operates through sub-brands HealthConfirm and Drugconfirm, leveraging lateral flow immunoassay and rapid antigen detection chemistry manufactured under ISO 13485 and UL RCP certifications, with FDA 510(k) and de novo clearances.
The business model combines national branded product sales (through drugstores and mass/grocery), private label manufacturing for major retailers (including retailer-branded pregnancy and COVID/Flu tests), and direct enterprise/government sales to clinics, employers, and federal/state/local agencies. Pricing is quote-based through a B2B order portal and not publicly disclosed. Distribution spans 20,000+ retail locations through partnerships with Rite Aid, Walgreens, Walmart, CVS, H-E-B, and Bi-Mart. Value-added services — regulatory management and filings, supply chain warehousing/fulfillment, and enterprise training/certification — are positioned as strategic differentiators that extend beyond commodity manufacturing.
Operationally, the company runs a headcount of 11-50 employees from a single San Diego headquarters, holds a 20+ year operating history, and relies on major retail concentration as both its main commercial advantage and principal concentration risk. No revenue or funding figures are disclosed in available sources.
TestCountry firmographics
Firmographics- Name
- TestCountry
- Legal name
- Confirm Biosciences
- Website
- https://testcountry.com
- Company type
- Private
- Founded year
- 2001
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Confirm Biosciences (TestCountry) is a San Diego-based OTC diagnostics manufacturer of at-home drug-of-abuse, infectious disease, and women's health tests, selling branded and private-label products through 20,000+ US retail locations and direct enterprise and government channels.
- Ownership category
- akta.pro rank
TestCountry industry classification
Industry- Product category
- Diagnostic Medical Devices
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Packaging and Labeling Services (56191)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Home Diagnostic & Self-Test OTC Kits (HLAIADAO)
Keywords
Where TestCountry is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
TestCountry business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Operations, Supply Chain, Personnel, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- National Brand Product Sales: Sale of branded OTC diagnostic products including pregnancy tests, COVID-19/Flu tests, UTI tests, and drug screening kits through retail partners
- Private Label Manufacturing: Custom manufacturing and private labeling of diagnostic products for major retail chains, including regulatory support and supply chain fulfillment
- Enterprise Training & Certification: Training and certification services for enterprise clients on diagnostic testing and compliance
Go-to-market motion1 record
Distribution channels3 records
Marketing channels3 records
TestCountry product offering
Product offeringCore offering
TestCountry (Confirm Biosciences) manufactures and distributes over-the-counter rapid diagnostic test kits, including drugs-of-abuse tests, infectious disease tests (COVID-19/Flu A&B antigen), and women's health tests (pregnancy, UTI/pH, and vaginal health screening). The company also offers end-to-end private label manufacturing, regulatory filing support, supply chain warehousing and fulfillment, and enterprise training and certification for retail and institutional clients across the United States.
Product overview
Confirm Biosciences is a diagnostic and over-the-counter (OTC) testing products company offering a portfolio of branded and private-label products across three main categories: Drugs of Abuse Testing, Infectious Disease Tests (including COVID-19/Flu antigen tests), and Women's Health Tests (including pregnancy tests, UTI/pH kits, and vaginal health screening). The company provides end-to-end services including private label manufacturing, supply chain fulfillment, regulatory management and FDA filings, and enterprise training and certification. Products are available as national brands through retail partners and can be customized for private label clients.
Differentiator
Problem solved
Functional benefit
Brands
- HealthConfirm: Brand for health-related at-home test kits including UTI tests, pregnancy tests, and COVID-19/Flu tests
- Drugconfirm
Products and services
- Drugs of Abuse Testing (point-of-care drug test kits)
- Infectious Disease Tests (COVID-19/Flu A&B antigen tests)
- Women's Health Tests (pregnancy, UTI/pH, vaginal health)
- 6 Days Sooner Pregnancy Test
- COVID-19/Flu A&B Antigen Test
- Urinary Tract Infection & pH At-Home Test Kit
- Vaginal Health Screening Kit
- Private Labeling Services
- Supply Chain Warehouse & Fulfillment
- Regulatory Management & Filings
- Enterprise Training & Certification
Quantifiable outcome
- Products available in 20,000+ retail locations nationwide
Companies that use TestCountry
Customer profileNamed customers9 records
Segments4 records
Ideal customer profiles4 records
TestCountry technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
TestCountry partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- Rite AidcoreMajor retail pharmacy chain distributing Confirm Biosciences branded diagnostic products through their retail locations nationwide.
- WalgreenscoreNational pharmacy chain partner distributing OTC diagnostic products including drug tests, infectious disease tests, and women's health products.
- WalmartcoreMajor retail partner for products including 6 Days Sooner Pregnancy Test, COVID-19/Flu Antigen Tests through Walmart retail and online channels.
- CVS HealthcoreNational pharmacy chain partner for OTC diagnostic product distribution through CVS retail locations.
- H-E-BcoreRegional grocery retailer partner distributing diagnostic products in Texas and surrounding markets.
- Bi-MartminorRegional retail chain partner distributing OTC diagnostic products in Pacific Northwest stores.
Scale indicators3 records
Recent moves6 records
Expansion highlights4 records
TestCountry competitors and assessment
Company assessmentDirect peers
- BTNX Inc. BTNX is a rapid diagnostic test manufacturer with comparable OTC product lines (drugs of abuse, infectious disease, women's health) sold through similar retail and workplace channels, making it a close functional and customer-overlap peer.
- Premier Biotech: Premier Biotech focuses on drugs-of-abuse testing products for workplace, clinical, and at-home use, overlapping significantly with Confirm's Drugconfirm line and customer segments.
- Wondfo Biotech: Wondfo is a global OTC diagnostic manufacturer with overlapping product categories (pregnancy, drugs of abuse, infectious disease) using comparable lateral flow technology and similar retail/wholesale distribution models.
- ACON Laboratories: ACON Laboratories is a direct competitor producing Mission-brand OTC rapid diagnostic tests (drugs of abuse, pregnancy, infectious disease) with very similar product mix, FDA-cleared lateral flow technology, and global retail distribution — directly comparable in product, customer, and technology.
- Princeton BioMeditech Corporation: Princeton BioMeditech manufactures FDA-cleared rapid drug screening and infectious disease tests sold through workplace, clinical, and retail channels — a direct comparable in product category and target customer base.
Emerging players
- Mankind Pharma: Mankind Pharma is expanding its at-home pregnancy and diagnostic test portfolio, representing an emerging competitor with comparable OTC product focus though primarily operating in a different geography (India) with growing US ambitions.
Broad incumbents
- Church & Dwight (First Response): Church & Dwight owns the First Response pregnancy test brand, a direct competitor in Confirm's women's health category and a major OTC consumer-health incumbent with deep retail relationships across the same pharmacy chains.
- Abbott Diagnostics: Abbott is a global diagnostics leader whose rapid test portfolio (Binax, ID NOW, and consumer products via Swiss Precision Diagnostics/Clearblue) competes in several of Confirm's categories at much larger scale and brand spend.
- Swiss Precision Diagnostics (Clearblue): Swiss Precision Diagnostics (jointly owned by P&G and Abbott) markets the Clearblue pregnancy and ovulation test brand, directly competing with Confirm's HealthConfirm pregnancy line on the same retailer shelves.
- QuidelOrtho: QuidelOrtho is a major IVD incumbent with a broad portfolio across rapid diagnostics (including Sofia and QuickVue brands) overlapping with Confirm's infectious disease and women's health categories, though at materially larger scale and broader clinical focus.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights5 records
Customer concentration
TestCountry social profiles
Digital presenceTestCountry compliance and trust
Trust signalCompliance3 records
TestCountry financial estimates
Financial estimateRevenue estimate
Valuation estimate
TestCountry leadership team
Management profileNumber of profiles
TestCountry funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
TestCountry 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 TestCountry
What does TestCountry do?
TestCountry (Confirm Biosciences) manufactures and distributes over-the-counter rapid diagnostic test kits, including drugs-of-abuse tests, infectious disease tests (COVID-19/Flu A&B antigen), and women's health tests (pregnancy, UTI/pH, and vaginal health screening). The company also offers end-to-end private label manufacturing, regulatory filing support, supply chain warehousing and fulfillment, and enterprise training and certification for retail and institutional clients across the United States.
Is TestCountry a public or private company?
TestCountry is a private company. It is classified as unknown and is currently operating.
When was TestCountry founded?
TestCountry was founded in 2001. It employs 11 to 50 people.
Where is TestCountry based?
TestCountry is headquartered in San Diego, United States, in the North America region.
How does TestCountry make money?
Three revenue lines are on record. National Brand Product Sales are the primary driver. The others are private Label Manufacturing and enterprise Training & Certification.
Who are TestCountry's main competitors?
Direct peers on record are BTNX Inc., Premier Biotech, Wondfo Biotech, ACON Laboratories and Princeton BioMeditech Corporation. Mankind Pharma is listed as an emerging player. Broad incumbents are Church & Dwight (First Response), Abbott Diagnostics, Swiss Precision Diagnostics (Clearblue) and QuidelOrtho.
Does TestCountry have an API?
No public API is recorded for TestCountry.
What industry is TestCountry in?
TestCountry's product category is Diagnostic Medical Devices. Its primary akta.pro industry code is HLAIADAO, Home Diagnostic & Self-Test OTC Kits. Its NAICS code is 325413 and its SIC code is 2835.