Biolabs International

What Biolabs International does

Biolabs International, LLC is a privately held diagnostic distribution company headquartered in San Diego, California, with operational entities in Mexico (BioLabs Pharmaceutical Group S.A. de C.V., Advin Manufacturing, S. de R.L. de C.V., and Biotest Biotech Co., LTD). Founded in 2020, the company operates as an FDA-recognized Importer of Record and authorized distributor for a broad portfolio of in vitro diagnostic products, including rapid antigen tests, point-of-care diagnostics, forensic drug detection kits, and consumer health self-tests. BioLabs holds exclusive distribution partnerships in the United States and Mexico for branded diagnostics including Watmind's SpeedySwab line and the AI-assisted Powder Tracer platform, and it claims distribution of 200+ million products cumulatively across government, retail, and healthcare channels worldwide.

The company's product strategy centers on connected diagnostic ecosystems that link testing to treatment and analytics. The SpeedySwab family delivers FDA EUA-authorized COVID-19 and influenza A&B detection with a 15-minute turnaround, 92.5% COVID-19 clinical sensitivity, and an 18-month shelf life; the SpeedySwab Mobile App integrates results with licensed telehealth consultations for automated test-to-treat workflows. Powder Tracer uses lateral flow technology with AI-assisted image interpretation on a mobile platform to detect fentanyl, cocaine, methamphetamine, ketamine, MDMA, opiates, and xylazine from environmental surfaces in under five minutes, generating digital forensic reports. Real-time operational analytics are powered by Amazon QuickSight and Google Analytics 4, supporting post-market surveillance, retail insights, and anomaly detection.

BioLabs generates revenue primarily through distribution economics: exclusive distribution agreements, volume sales of in vitro diagnostics, and ancillary fees tied to its telehealth-integrated test-to-treat solutions (SpeedySwab is HSA/FSA-eligible). Its customer base spans four primary verticals: government and public health programs (state and federal), national retail and pharmacy chains (OTC diagnostics), enterprise and institutional buyers, and a growing law enforcement and forensics segment. The company serves U.S. and Mexico markets directly and has expanded authorized distribution into South America and the United Kingdom via a partnership with CAINA for laboratory consumables. No public revenue figures, funding rounds, or detailed financial disclosures beyond the 11–50 employee range are available in current sources.

Name

Biolabs International

Legal name

BioLabs International, LLC

Website

https://biolabsinternational.net

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Biolabs International is an FDA-recognized Importer of Record and exclusive diagnostic distributor headquartered in San Diego, operating across the U.S. and Mexico. It distributes rapid tests, forensic drug detection tools, and consumer health diagnostics through government, retail, enterprise, and law enforcement channels.

Ownership category

akta.pro rank

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Product Distribution: Revenue generated from distribution of in vitro diagnostic products including rapid antigen tests, molecular diagnostics, multiplex assays, and medical devices through retail, institutional, and government channels.
2. Exclusive Distribution Partnerships: Long-standing exclusive distribution agreements for SpeedySwab and PowderTracer products across United States and Mexico markets.

Go-to-market motion1 record

Distribution channels5 records

Marketing channels4 records

Core offering

Biolabs International is an authorized distributor and FDA-recognized Importer of Record for in vitro diagnostic products, distributing rapid antigen tests (SpeedySwab COVID-19/Flu A&B), OTC self-tests (pregnancy, UTI, FOB, ovulation), forensic drug detection kits (Powder Tracer, RapiSure), and laboratory consumables. The company operates exclusive distribution partnerships across the United States and Mexico, supplementing product distribution with connected diagnostic technology including the SpeedySwab Mobile App for AI-assisted test interpretation and integrated telehealth.

Product overview

Biolabs International is a distributor and importer of record for a broad portfolio of in vitro diagnostic products spanning OTC rapid tests, point-of-care solutions, drug and forensic tests, and medical devices. The core product portfolio centers on the SpeedySwab family of rapid antigen combo tests for COVID-19 and influenza, complemented by OTC diagnostics (pregnancy tests, ovulation predictors, UTI tests, FOB tests), forensic drug detection solutions including the AI-powered Powder Tracer platform, and medical devices for blood collection and nucleic acid processing. Products are distributed across retail, institutional, government, and community-based channels in the U.S. and Mexico markets.

Differentiator

Problem solved

Functional benefit

Brands

• SpeedySwab: Rapid COVID-19 and Flu A&B antigen self-test with integrated telehealth - the only respiratory test on the market with integrated telehealth.
• PowderTracer
• VeriClear
• GENABIO
• SeraPen
• Rapid-X-Tract
• RapiSure
• GenaCheck
• GenaCheck
• Digital Ovulation Predictor

Products and services

• SpeedySwab COVID-19 and Flu A&B 3-in-1 Antigen Rapid Combo Test FDA EUA authorized rapid antigen combo test for simultaneous detection of COVID-19, Influenza A, and Influenza B using lateral flow assay technology; delivers results in 15 minutes with 92.5% clinical sensitivity for COVID-19.
• SpeedySwab Rapid COVID-19 Antigen Self-Test Lateral flow immunoassay device for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2; authorized for non-prescription home use with self-collected anterior nasal samples.
• GENABIO COVID-19 Rapid Self-Test Lateral flow immunoassay for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
• SpeedySwab 3-in-1 Antigen Rapid Combo Test (Point-of-Care) Point-of-care version of the FDA EUA authorized rapid antigen combo test for COVID-19, Flu A, and Flu B detection with nasal application, intended for professional clinical use.
• Powder Tracer AI-powered rapid lateral flow surface test detecting fentanyl, cocaine, methamphetamine, ketamine, MDMA, opiates, and xylazine from environmental surfaces and suspicious powders, with mobile app integration for AI-assisted analysis and digital forensic reporting.
• Fentanyl Urine Test Cassette FDA-approved rapid fentanyl test with 1 ng/ml lower cutoff, delivering results in 5 minutes for clinical and harm reduction use.
• RapiSure Fentanyl and Xylazine Test Kit Combo test strip kit for rapid detection of fentanyl and xylazine (Tranq) in pills or powders with easy-to-read analysis chart for harm reduction testing.
• VeriClear Pregnancy Test Digital hCG early result pregnancy test using lateral flow immunoassay with LCD display showing YES+, NO-, or invalid results.
• Digital Ovulation Predictor Digital device tracking hormonal changes by detecting luteinizing hormone surges in urine to predict ovulation for fertility planning.
• Rapid Self-Test Kit for Urinary Tract Infection Over-the-counter rapid test for qualitative detection of leukocytes and nitrite in urine as an aid in screening for urinary tract infections.
• Rapid Self-Test Kit for FOB Qualitative detection of human occult blood in fecal specimens for over-the-counter, laboratory, and physician office use.
• SeraPen Dry Blood Collection Kit All-in-one home blood specimen collection kit with prepaid return envelope for patient self-collection from home.
• Rapid-X-Tract Dual-function collection device and pre-treatment solution that releases nucleic acids for direct PCR or RT-PCR detection.
• Laboratory Consumables (CAINA) Premium laboratory consumables distributed under authorized agreement with CAINA for USA, Mexico, South America, and the United Kingdom.
• SpeedySwab Mobile App Digital companion app connecting SpeedySwab test-to-treat workflow with AI-assisted interpretation and licensed telehealth consultations, driving consumer traffic to retail pharmacies.

Quantifiable outcome

• 200+ million products distributed across government, retail, and healthcare channels worldwide
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability5 records

Feature5 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Watmind USAcoreChannel Partner/ Reseller/ Distributor · 28 May 2024Exclusive distribution agreement with Watmind USA for next-generation diagnostics platform. BioLabs International is the exclusive U.S. distributor for SpeedySwab products including COVID-19, Flu A&B antigen tests. Watmind manufactures FDA EUA authorized diagnostic products distributed exclusively by BioLabs.
• Phoenix AssurancecoreStrategic or Co-development PartnerStrategic partnership with Phoenix Assurance, a trusted healthcare and pharmaceutical 3PL provider. Phoenix operates multiple facilities across the U.S. with millions of square feet of cGMP-compliant warehousing and distribution space. Provides controlled temperature environments (cold and ambient ranges), regulatory compliance for Healthcare & Pharma, and tailored logistics including packaging, labeling, order fulfillment, cold-chain management, and transportation.
• CAINAminorChannel Partner/ Reseller/ DistributorAuthorized distributor for CAINA laboratory consumables in USA, Mexico, South America, and the United Kingdom. CAINA is a trusted manufacturer renowned for commitment to excellence in laboratory supplies. Partnership enables researchers and scientists across these regions to access premium-quality lab supplies.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Henry Schein: Major distributor of medical, dental, and diagnostic products with strong relationships across physician offices, retail pharmacies, and government channels. Comparable go-to-market model for distributing OTC and point-of-care diagnostic products into retail and institutional buyers.
• BTNX Inc. Canadian-based rapid test manufacturer and distributor with overlapping product portfolio across COVID-19, pregnancy, ovulation, drug-of-abuse, and infectious disease tests. Comparable in lateral flow IVD breadth and international distribution into retail and institutional channels.
• iHealth Labs: OTC rapid antigen test manufacturer/distributor that gained scale through COVID-19 self-testing distribution. Directly comparable in the OTC rapid COVID/Flu self-test category and digital/telehealth-integrated consumer diagnostics.
• Access Bio: Manufacturer and global distributor of rapid diagnostic tests including COVID-19, flu, pregnancy, and drug tests. Comparable in product mix (lateral flow IVDs across respiratory, women's health, and substance detection) and in cross-border distribution model.

Broad incumbents

• Cardinal Health: Top-tier US medical product distributor serving retail pharmacies, hospitals, and government health programs. Overlaps with Biolabs in wholesale distribution of diagnostic products into national pharmacy and public-sector channels.
• Becton Dickinson (BD): Global medical technology and IVD company with a substantial diagnostic systems and specimen collection portfolio (including rapid molecular and lateral flow tests). Comparable in distributing IVD products across retail pharmacy, government, and institutional channels.
• McKesson Corporation: Largest US pharmaceutical and medical product distributor with extensive diagnostic product lines. Directly comparable as a medical/diagnostic distributor serving retail pharmacy chains, government health programs, and enterprise healthcare buyers — though at vastly greater scale and breadth.
• Abbott (Rapid Diagnostics / BinaxNOW): Major diagnostics incumbent behind BinaxNOW COVID/Flu rapid tests and a broad IVD portfolio distributed through retail and institutional channels. Comparable in respiratory rapid test category where SpeedySwab competes and in retail pharmacy distribution channels.
• QuidelOrtho: Major IVD manufacturer across rapid immunoassays, Sofia platform respiratory tests, and OTC diagnostics. Comparable in respiratory rapid test category and broader OTC/point-of-care IVD portfolio that competes for the same retail shelf space as SpeedySwab.
• Premier Inc. Healthcare supply chain and group purchasing organization serving hospitals and government health programs. Comparable in distributing diagnostic products at scale into enterprise healthcare and public-sector buyers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biolabs-international-llc

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries3 records

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 Biolabs International