AmplifiDx
AmplifiDx is a privately held point-of-care molecular diagnostics company developing the DX 100 NAAT platform and a menu of respiratory, sexual, and women's health assays targeting community clinics, physician offices, urgent care centers, and women's health providers.
- Company typePrivate
- Founded2020
- HeadquartersPleasanton, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What AmplifiDx does
AmplifiDx is a privately held point-of-care molecular diagnostics company founded in 2020 and headquartered in Newark, California, with a secondary office in Waltham, Massachusetts. The company is developing the DX 100 Platform, a compact nucleic acid amplification testing (NAAT) system designed to deliver multiplexed infectious disease detection (up to 10 analytes simultaneously) in under 20 minutes with less than one minute of hands-on time. The platform's clinical performance was validated in a study of the first-generation DX 1000 System running the AmplifiDx COVID-19 Assay, demonstrating 97.8% positive percent agreement and 100% negative percent agreement against the Roche cobas Liat PCR comparator. All products remain under development and are not yet cleared or approved by the FDA.
The intended assay menu spans respiratory pathogens via the RespiFast Test (SARS-CoV-2, Influenza A/B, RSV) and a pipeline of sexual and women's health tests including STI NG Plus, SYPHony (syphilis), iVAGine, and CerviGARD (cervical health screening). The business model is structured as a razor-and-blade — placement of the DX 100 instrument paired with recurring single-use assay cartridge sales — targeting community and rural health clinics, physician offices, urgent care centers, and women's/sexual health providers seeking test-to-treat workflows within a single patient visit. Go-to-market is sales-led and direct to U.S. healthcare facilities. The company has assembled a four-person C-suite (CEO Nancy Schoenbrunner, CSO Shoulian Dong, CPO Daniel Schoener, CCO Chris Meda) and operates with a headcount of 1–10.
Financially, AmplifiDx has been funded primarily through non-dilutive NIH Rapid Acceleration of Diagnostics (RADx) Tech grants totaling $4.51 million (initial $1.38M award in May 2023 and $954,213 in December 2024), supplemented by an approximately $1.8 million seed round in January 2022 from SeedFolio, Social Starts, and Titan Angels, and additional smaller tranches. The company has not generated commercial revenue and remains pre-FDA. Its strategic posture is to leverage multiplex accuracy and POC usability to compete in the test-to-treat diagnostics category against established players such as Cepheid, Abbott ID NOW, and Roche cobas Liat, with a differentiated focus on women's and sexual health applications.
AmplifiDx firmographics
Firmographics- Name
- AmplifiDx
- Legal name
- AmplifiDx, Inc.
- Website
- https://amplifidx.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- AmplifiDx is a privately held point-of-care molecular diagnostics company developing the DX 100 NAAT platform and a menu of respiratory, sexual, and women's health assays targeting community clinics, physician offices, urgent care centers, and women's health providers.
- Ownership category
- akta.pro rank
AmplifiDx industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)
- akta.pro primary industry
- Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges) (HLAHAOAI)
- akta.pro secondary industry
- Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)
Keywords
Where AmplifiDx is headquartered
LocationHeadquarters
- HQ city
- Pleasanton
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
AmplifiDx business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- Diagnostic Platform Hardware: Sale of the DX 100 instrument system to healthcare providers including clinics, physician offices, and urgent care centers.
- Diagnostic Assay Consumables: Single-use test cartridges and assays for the DX 100 Platform including RespiFast, STI NG Plus, iVAGine, SYPHony, and CerviGARD tests.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels3 records
AmplifiDx product offering
Product offeringCore offering
AmplifiDx develops and sells a point-of-care molecular diagnostic platform (DX 100) and a portfolio of single-use assay cartridges for infectious disease detection. The platform delivers PCR-grade accuracy in under 20 minutes with less than one minute of hands-on time and can detect up to 10 analytes simultaneously from a single sample. Target users are healthcare providers in community clinics, physician offices, and urgent care centers; products are not yet FDA cleared or approved.
Product overview
AmplifiDx offers a unified platform-plus-assays portfolio centered on the DX 100™ Platform, a point-of-care molecular diagnostic system. The platform enables rapid multiplex testing (up to 10 analytes per test) with results in under 20 minutes and less than one minute hands-on time. Currently marketed and developing assays include: RespiFast™ (respiratory pathogens: SARS-CoV-2, Flu A/B, RSV), STI NG Plus™ (sexual health), SYPHony™ (syphilis), iVAGine™ (women's health), and CerviGARD™ (women's/cervical health). The company also developed the AmplifiDx COVID-19 Assay™ for the first-generation DX 1000 System™. All products are not yet cleared or approved by the FDA.
Differentiator
Problem solved
Functional benefit
Brands
- DX 100 Platform: Point-of-care molecular diagnostic platform that detects up to 10 analytes simultaneously, providing results in under 20 minutes with less than 1 minute hands-on time.
- RespiFast Test
- STI NG Plus
- iVAGine
- SYPHony
- CerviGARD
Products and services
- DX 100 Platform Point-of-care molecular diagnostic instrument platform delivering fast, accurate results in under 20 minutes with less than one minute of hands-on time. Detects up to 10 analytes simultaneously and is designed for healthcare providers in community clinics, physician offices, and urgent care centers.
- RespiFast Test Single-use molecular point-of-care assay cartridge for the DX 100 Platform that detects and differentiates SARS-CoV-2, Influenza A, Influenza B, and RSV, delivering results within 20 minutes to support immediate treatment decisions.
- AmplifiDx COVID-19 Assay Molecular diagnostic assay for SARS-CoV-2 detection, validated on the first-generation DX 1000 System with 97.8% positive percent agreement and 100% negative percent agreement compared to the Roche cobas liat PCR comparator.
- DX 1000 System First-generation molecular diagnostic instrument used in clinical studies validating the AmplifiDx COVID-19 Assay and reporting 97.8% PPA and 100% NPA versus the Roche cobas liat comparator.
- STI NG Plus Sexually transmitted infection multiplex test in development on the DX 100 Platform, intended to expand the company's sexual health diagnostics menu at the point of care.
- iVAGine Women's health point-of-care diagnostic test in development on the DX 100 Platform, leveraging the platform's multiplex detection capability.
- SYPHony Syphilis diagnostic test in development on the DX 100 Platform, part of the sexual health testing portfolio targeting point-of-care screening and treatment initiation.
- CerviGARD Cervical health screening test in development on the DX 100 Platform, intended to extend women's health diagnostics into point-of-care cervical screening workflows.
Quantifiable outcome
- 97.8% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA) compared to Roche cobas Liat PCR system
- +3 more outcomes
Companies that use AmplifiDx
Customer profileSegments5 records
Ideal customer profiles3 records
AmplifiDx technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
AmplifiDx partnerships and signals
Strategic signalScale indicators2 records
Recent moves6 records
Expansion highlights6 records
AmplifiDx competitors and assessment
Company assessmentDirect peers
- Qiagen: QIAstat-Dx is a multiplex molecular POC platform for respiratory and other syndromic panels, directly comparable to AmplifiDx's multiplex NAAT approach in target customers and menu strategy.
- BioMérieux: BioFire FilmArray is a multiplex syndromic molecular testing platform used in clinical settings; AmplifiDx's 10-plex NAAT ambition for respiratory, STI, and women's health panels directly competes with FilmArray's multiplexing value proposition.
- Cepheid (Danaher): GeneXpert is the dominant molecular POC/CLIA-waived NAAT system deployed across clinics and hospitals globally; AmplifiDx targets the same NAAT-POC workflows with a more compact, lower-cost, multiplex-focused instrument.
Emerging players
- Visby Medical: Visby offers a single-use, instrument-free PCR device for STI and infectious disease testing at POC; a relevant emerging competitor demonstrating both the opportunity and capital intensity of the molecular POC market.
- Cue Health: Cue developed a connected molecular POC COVID/flu test for consumer and clinical use; a similarly positioned emerging molecular POC company competing for the same decentralized testing narrative.
- Talis Biomedical: Talis pursued a cartridge-based molecular POC platform for infectious disease testing; useful as a peer showing the development, regulatory, and commercialization challenges facing AmplifiDx's category.
Broad incumbents
- Abbott: Abbott's ID NOW is an established isothermal molecular POC platform with broad clinic penetration; a direct head-to-head competitor for rapid, instrument-based molecular infectious disease testing at the point of care.
- Roche Diagnostics: Roche's cobas Liat system is the named PCR comparator in AmplifiDx's clinical study and a leading molecular POC platform, making Roche the most directly relevant incumbent benchmark for performance, scale, and FDA-cleared distribution.
- QuidelOrtho: QuidelOrtho's Sofia and Savanna platforms span rapid immunoassay and molecular POC diagnostics; a broad incumbent with established CLIA-waived channels that AmplifiDx would need to dislodge.
Others
- Mesa Labs: Mesa Labs provides quality control, calibration, and proficiency testing materials for IVD workflows; adjacent infrastructure supplier relevant to AmplifiDx's IVD consumables business model.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
AmplifiDx social profiles
Digital presenceAmplifiDx financial estimates
Financial estimateRevenue estimate
Valuation estimate
AmplifiDx leadership team
Management profileNumber of profiles
Profiles4 records
AmplifiDx funding detail
Funding detailFunding overview
Funding rounds5 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
AmplifiDx 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 AmplifiDx
What does AmplifiDx do?
AmplifiDx develops and sells a point-of-care molecular diagnostic platform (DX 100) and a portfolio of single-use assay cartridges for infectious disease detection. The platform delivers PCR-grade accuracy in under 20 minutes with less than one minute of hands-on time and can detect up to 10 analytes simultaneously from a single sample. Target users are healthcare providers in community clinics, physician offices, and urgent care centers; products are not yet FDA cleared or approved.
Is AmplifiDx a public or private company?
AmplifiDx is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was AmplifiDx founded?
AmplifiDx was founded in 2020. It employs 1 to 10 people.
Where is AmplifiDx based?
AmplifiDx is headquartered in Pleasanton, United States, in the North America region.
How does AmplifiDx make money?
Two revenue lines are on record. Diagnostic Platform Hardware is the primary driver. The others are diagnostic Assay Consumables.
Who are AmplifiDx's main competitors?
Direct peers on record are Qiagen, BioMérieux and Cepheid (Danaher). Emerging players are Visby Medical, Cue Health and Talis Biomedical. Broad incumbents are Abbott, Roche Diagnostics and QuidelOrtho. Mesa Labs is listed as an others.
Does AmplifiDx have an API?
No public API is recorded for AmplifiDx.
What industry is AmplifiDx in?
AmplifiDx's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAHAOAI, Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges), with a secondary code of HLAAALAL, Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays). Its NAICS code is 325413 and its SIC code is 2835.