Sedia Biosciences

What Sedia Biosciences does

Sedia Biosciences Corporation is a privately held, Delaware-registered medical device and diagnostics company founded in 2009 and headquartered in a 27,000 sq ft facility in Beaverton, Oregon. The company develops and manufactures in vitro diagnostic products for HIV, anchored by two platforms: the Asanté® line of rapid point-of-care lateral flow assays (including the HIV-1 Rapid Recency® Assay and the HIV-1/2 Oral Fluid Test, both designed for decentralized settings and validated across multiple HIV-1 subtypes) and the laboratory-based Sedia® HIV-1 LAg-Avidity EIA used for population-level incidence surveillance. Core technologies are licensed from the U.S. CDC and are qualified by CDC prior to each commercial release, with WHO Pre-Qualification secured in January 2026 for the Oral Fluid Test. Supporting products include Asanté® Oral Collection Kits and Dried Blood Specimen Collection Strips that enable remote specimen logistics in resource-limited settings.

The company sells primarily to government health agencies and public health programs — notably PEPFAR and ministries of health in countries such as Malawi, Nigeria, Lesotho, Zimbabwe, Uganda, Kenya, South Africa, Vietnam, and Taiwan — through direct enterprise field sales and quote-based procurement. Revenue streams consist of hardware sales across rapid tests, laboratory assays, and specimen collection devices, plus professional services including HIV incidence testing, COVID-19 whole genome sequencing, and DNA sequencing. The wholly-owned Floragenex subsidiary (acquired October 2016) adds agrigenomics and next-generation DNA sequencing services, and in March 2026 Sedia became a co-exclusive global distributor of Thermo Fisher Scientific's AgriSeq™ agri genomics products, excluding US embargoed countries. Sedia holds ISO 13485:2016 certification from TÜV SÜD and has been funded primarily through NIH SBIR grants (~$1.95M disclosed) and Business Oregon matching grants rather than institutional venture capital.

Name

Sedia Biosciences

Legal name

Sedia Biosciences Corporation

Website

https://sediabio.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Sedia Biosciences develops rapid point-of-care and laboratory HIV diagnostic and incidence surveillance assays, plus specimen collection devices, selling primarily to PEPFAR, national ministries of health, and UN agencies in resource-limited settings globally.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC)

akta.pro secondary industries

Sample Logistics, Biorepository & IVD Kit Management (Trial Support) (HLAGAEAI), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• HIV diagnostic tests
• Rapid point-of-care assays
• Specimen collection devices
• HIV incidence surveillance
• Lateral flow immunoassays

Headquarters

HQ city

Beaverton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Rapid Diagnostic Tests: Sale of Asanté® rapid point-of-care assays including HIV-1 Rapid Recency® Assay and HIV-1/2 Oral Fluid Test for use in clinical and surveillance settings
2. Laboratory-Based HIV Incidence Assays: Sale of Sedia® HIV-1 LAg-Avidity EIA for laboratory-based HIV incidence surveillance and research applications
3. Specimen Collection Devices: Sale of specimen collection products including dried blood specimen collection strips and oral collection kits for DNA, antibody, and biomarker collection
4. Custom Testing Services: HIV incidence testing services, COVID-19 whole genome sequencing, and DNA sequencing through subsidiary Floragenex
5. AgriSeq™ Distribution: Global authorized distribution of Thermo Fisher Scientific's AgriSeq™ agri genomics products under co-exclusive distribution agreement, providing reliable revenue stream

Pricing tiers

Go-to-market motion2 records

Distribution channels6 records

Marketing channels6 records

Core offering

Sedia Biosciences manufactures and sells in vitro diagnostic products for HIV diagnosis and population-level incidence surveillance. Its portfolio includes the Asanté® rapid lateral-flow point-of-care assays (HIV-1 Rapid Recency® Assay and HIV-1/2 Oral Fluid Test), the laboratory-based SEDIA® HIV-1 LAg-Avidity EIA, and Asanté® specimen collection devices (oral fluid kits and dried blood strips). The company also provides custom testing services and, through its Floragenex subsidiary, distributes Thermo Fisher AgriSeq™ agricultural genomics products.

Product overview

Sedia Biosciences is a medical device and diagnostics company that develops and manufactures in vitro diagnostic products for infectious disease surveillance and diagnosis, primarily focused on HIV. The product portfolio comprises two core assay platforms: the Asanté® rapid point-of-care assay line (including the HIV-1 Rapid Recency® Assay and HIV-1/2 Oral Fluid Test) designed for decentralized testing in resource-limited settings, and the laboratory-based SEDIA® HIV-1 LAg-Avidity EIA for population-level incidence surveillance. Supporting these are specimen collection devices (Asanté® Oral Collection Kits and Dried Blood Specimen Collection Strips) that facilitate remote specimen collection. Services include custom testing through Sedia's facilities and, via its Floragenex subsidiary, agrigenomics and genomic sequencing services including distribution of Thermo Fisher AgriSeq™ products.

Differentiator

Problem solved

Functional benefit

Brands

• Asanté®: Rapid point-of-care diagnostic assays including HIV-1 Rapid Recency® Assay and HIV-1/2 Oral Fluid Test.
• Sedia® HIV Lab Based Products
• Floragenex

Products and services

• Asanté® HIV-1 Rapid Recency® Assay A point-of-care lateral flow rapid test that simultaneously verifies HIV-1 diagnosis and classifies infection as recent or long-term, with results in approximately 20 minutes. Used by public health surveillance programs, ministries of health, and clinical settings in resource-limited environments.
• Asanté® HIV-1/2 Oral Fluid Test A single-use, qualitative immunoassay for rapid detection of HIV-1 and HIV-2 antibodies in oral fluid specimens. WHO Pre-Qualified for global procurement by UN agencies including UNAIDS, UNICEF, and UNDP.
• SEDIA® HIV-1 LAg-Avidity EIA A laboratory-based enzyme immunoassay that measures HIV-1 antibody avidity to distinguish recent from long-term infections for population-level HIV incidence estimation and surveillance studies. Uses limiting antigen technology for cross-subtype performance.
• Asanté® Oral Collection Kits Collection devices for oral fluid specimens containing antibodies, proteins, DNA, or other biomarkers. Includes the Asanté® Oral Ab Collection Kit and Asanté® Oral DNA Collection Kit in 10, 50, and 250 unit packs.
• Asanté® Dried Blood Specimen Collection Strips An alternative to traditional dried blood spot cards for collection, preservation, and transport of dried blood specimens. Available in three sizes for antibody, enzyme, protein assays, and biobanking applications.
• Sedia® Custom Testing Services Contract testing services including HIV incidence testing, COVID-19 whole genome sequencing, variant genotyping, and DNA sequencing performed in Sedia's Beaverton facilities using Sedia assays.
• Floragenex Agrigenomics Services and AgriSeq™ Distribution Floragenex subsidiary offering genomic analysis services for animal DNA and agrigenomics, including reduced representation sequencing. Authorized distributor of Thermo Fisher AgriSeq™ products (Ion 540™ and 550™ Chip Kits, HTS Library Kits, custom Sedia Panels) under co-exclusive global distribution agreement.

Quantifiable outcome

• Asante Rapid Recency Assay demonstrates >98% sensitivity and specificity for HIV-1 detection
• +2 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered core.

• Thermo Fisher ScientificcoreChannel Partner/ Reseller/ Distributor · 15 March 2026Co-exclusive global distribution agreement for AgriSeq™ agri genomics products. Sedia markets, sells, and supports full range of AgriSeq™ consumables (Ion 540™ and 550™ Chip Kits, HTS Library Kits) worldwide excluding US embargoed countries. Authorized to manufacture custom 'Sedia Panels' using Thermo Fisher primer materials.
• Floragenex Inc.coreStrategic or Co-development PartnerMerger completed October 2016; Floragenex operates as a wholly-owned subsidiary of Sedia Biosciences with CEO Dr. Rick Nipper continuing oversight. Floragenex specializes in genomic analysis services for human, plant, and animal systems using next-generation DNA sequencing.
• U.S. Centers for Disease Control and Prevention (CDC)coreStrategic or Co-development PartnerTechnology licensed from CDC; all HIV-1 Incidence Assays are tested and qualified by CDC prior to product release. Sedia's scientific team worked with CDC to develop first commercial assays for measuring recency of infection and HIV-1 incidence.
• PEPFAR (U.S. President's Emergency Plan for AIDS Relief)coreStrategic or Co-development PartnerImplementation of real-time HIV surveillance using recency assays under PEPFAR TRACE initiative across multiple countries approaching epidemic control. PEPFAR supports recency testing integration into routine HIV testing services.
• EQAPOL (External Quality Assurance for Optimal Standardization of Laboratory Tests)coreTechnology or IntegrationSedia participated in international EQA program for HIV-1 incidence using LAg assay, distributing proficiency panels to 20 international laboratories between 2016-2018.
• World Health Organization (WHO)coreStrategic or Co-development PartnerWHO recommended RITA (Recent Infection Testing Algorithm) incorporating Sedia's Asanté™ Rapid Recency Assay and LAg-Avidity EIA. WHO Pre-Qualification obtained January 2026 for Asanté® HIV-1/2 Oral Fluid Test.

Scale indicators5 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• OraSure Technologies: Direct peer in rapid point-of-care infectious disease diagnostics, including the OraQuick HIV rapid test and oral fluid specimen collection devices that compete head-to-head with Sedia's Asanté HIV-1/2 Oral Fluid Test and oral collection kits.
• Chembio Diagnostics: Direct peer in rapid POC infectious disease diagnostics with a portfolio of HIV and multiplex rapid tests targeting the same global health and resource-limited setting customers as Sedia.
• bioLytical Laboratories: Direct peer producing rapid HIV and other infectious disease point-of-care tests (INSTI HIV) sold through global public health channels, directly competing with Sedia's Asanté POC platform.
• Trinity Biotech: Direct peer with a legacy HIV diagnostic and incidence testing portfolio (including BED-based incidence assays) historically procured for HIV surveillance programs that overlap with Sedia's customer base.

Broad incumbents

• Abbott Diagnostics: Broad incumbent offering the Determine HIV rapid test as part of a much larger diagnostics portfolio, frequently procured by PEPFAR and national HIV programs alongside or instead of Sedia's assays.
• Roche Diagnostics: Broad incumbent providing HIV viral load and molecular diagnostics used in global HIV programs; a key long-term competitive threat as incidence surveillance shifts toward molecular algorithms.
• Cepheid (Danaher): Broad incumbent whose GeneXpert molecular platform is being deployed for HIV viral load and increasingly for recent-infection algorithms in PEPFAR-funded countries, creating substitution risk for Sedia's rapid LAg-based assays.
• QuidelOrtho: Broad incumbent in rapid immunoassay diagnostics with overlapping HIV and infectious disease product lines and established global distribution channels that compete with Sedia's reach.
• Mérieux NutriSciences / bioMérieux: Broad incumbent in microbiology and infectious disease diagnostics, with WHO-aligned HIV and tropical disease assays that compete for the same global health procurement contracts.

Emerging players

• InBios International: Emerging player in infectious disease diagnostics with WHO-aligned rapid tests and a similar public-health-focused go-to-market, competing for the same global procurement budgets.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/Sediabio
• Facebookfacebook.com/SediaBio
• LinkedInlinkedin.com/company/sedia-biosciences-corp-

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds4 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sedia Biosciences