Develops the DX 100™ Point-of-Care platform for rapid, multiplex-capable molecular diagnostics (LAMP/NAAT).

AmplifiDx, Inc.

Newark, CA (US) · Waltham, MA (US) · Irvine, CA (US) · Boston, MA (US) · Zurich (CH) · Yaoundé (CM) · Tokyo (JP)New on Amplifa

2020Founded

2-10Employees

7Locations worldwide

up to 10Analytes per test

<20 min.Time to result

About AmplifiDx

AmplifiDx, Inc. is a molecular diagnostics company founded in 2020 and based in Newark, California (Agility Labs), developing Point-of-Care tests for infectious diseases with a focus on sexual and women's health. The core product is the DX 100™ Platform, a molecular diagnostic system based on isothermal amplification (LAMP) with real-time fluorogenic detection that can detect up to 10 analytes simultaneously in a single test. The system works with nasal/throat swabs without additional sample preparation and delivers results in under 20 minutes with less than one minute of hands-on time. The assay portfolio includes, among others, RespiFast™, STI NG Plus™, AmpliCORE™, iVAGine™, SYPHony™ and CerviGARD™. Product development was carried out jointly with Veranex, supported by a RADx grant from the NIH, including prototype building, verification/validation according to the FDA Design Control process, and transfer to manufacturing. Target groups are community and rural health clinics, physician offices and urgent care centers.

Site: Newark, CA
Processes: Product development & engineering (molecular Point-of-Care system, isothermal amplification/LAMP), Prototyping (5 prototypes, design-to-functioning-prototype in under 90 days; industrial design), Verification & validation according to the FDA Design Control process (EUA submission), Transfer to manufacturing / bridging production (5 pre-production units), Assay development (LAMP/NAAT multiplex assays: AmpliCORE™, STI NG Plus™, iVAGine™, RespiFast™), Development of Point-of-Care molecular diagnostics (DX 100 Platform), Multiplex tests with up to 10 analytes, Test-to-Treat solutions
Materials: Nasal/throat swab as sample material for NAAT, Isothermal amplification (LAMP), Nucleic acid amplification test (NAAT)
Certificates: FDA Design Controls (EUA process)
Founded: 2020
Employees: 2-10
Industries: Medical technology/diagnostics, Point-of-Care Testing, Community & Rural Health Clinics, Physician Offices, Urgent Care Centers, Women's Health/Femtech

01
Product design & engineering
02
Prototyping (design-to-functioning-prototype in under 90 days)
03
Assay development (LAMP/NAAT multiplex)
04
Verification & validation according to the FDA Design Control process
05
Transfer to manufacturing / bridging production
06
Clinical studies & approval

Technology & Processes

LAMP

Isothermal amplification (LAMP)

Isothermal nucleic acid amplification with real-time fluorogenic detection for rapid multiplex detection of up to 10 analytes.

NAAT

Nucleic acid amplification test (NAAT)

Swab-based NAAT (e.g. RespiFast for COVID-19) with high sensitivity and specificity compared to gold-standard PCR.

Locations

Newark, CA

Headquarters / Agility Labs

DX 100™ Platform (development)

Waltham, MA

Location (Bioburst.io)

Zurich

Location

Products & Assays

**DX 100™ Platform**Point-of-Care molecular diagnostics · Medical technology

**RespiFast™ Assay**NAAT multiplex assay · Infectious disease diagnostics

Inside the production

Industries

Medical technology/diagnosticsPoint-of-Care TestingCommunity & Rural Health ClinicsPhysician OfficesUrgent Care CentersWomen's Health/FemtechInfectious Disease

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Product development & engineering (molecular Point-of-Care system, isothermal amplification/LAMP)Engineering	–	–	–	–	Sample material: nasal/throat swabs
Prototyping (5 prototypes, design-to-functioning-prototype in under 90 days; industrial design)Engineering	–	–	–	–	–
Verification & validation according to the FDA Design Control process (EUA submission)Testing	–	–	–	–	–
Transfer to manufacturing / bridging production (5 pre-production units)Assembly	–	–	–	–	–
Assay development (LAMP/NAAT multiplex assays: AmpliCORE™, STI NG Plus™, iVAGine™, RespiFast™)Engineering	–	–	–	–	–

3 Anlagen & Maschinen

Machine	Manufacturer / model	Quantity	Working area	Year built	Site
Point-of-Care molecular diagnostic system (isothermal amplification, multiplex up to 10 analytes)	AmplifiDx DX 100™ Platform	–	–	–	Newark, CA, USA
Point-of-Care diagnostic system (first-generation instrument)	AmplifiDx DX 1000 System™	–	–	–	–
Prototype/pre-production units of the DX-100 instrument	Veranex (development partner) DX-100	10 (5 prot	–	–	–

Additional services

Development of Point-of-Care molecular diagnostics (DX 100 Platform)Multiplex tests with up to 10 analytesTest-to-Treat solutionsAssay development (e.g. RespiFast, STI NG Plus, AmpliCORE)Cooperation with Veranex for product development/prototyping

Reference customers

Johns Hopkins Center for Innovative Diagnostics for Infectious DiseasesCommunity Health (Fair Health, Miami - clinical collaborator)Roche (comparison platform in clinical study)Drummond Scientific Company (partner)Evvi Design (partner)

Quality & Regulatory

Verification and validation are performed according to the FDA Design Control process as part of EUA submissions. Clinical studies with comparison platforms such as Roche cobas® liat demonstrate sensitivity and specificity.

Evidence	Newark, CA
FDA Design Controls (EUA process)

History

2020
Founding of AmplifiDx during the COVID pandemic by a team of industry veterans
2021
RADx grant from the NIH to develop the DX-100 instrument and RespiFast assay; proof of concept in under 90 days with Veranex
2026
Presentation of the DX100 Platform and STI NG Plus assay at ADLM 2026 in Anaheim