We bring the platform, you bring the assay
Our open platform and collaborative process give developers a breakthrough method to bring point-of-care assays to the market-faster.
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Your assays,
our OEM platform
Streamlined development
Our open platform eliminates testing, hardware and regulatory hurdles that slow down the current assay development process. This allows development partners to focus on their strengths—developing new assays that will diversify their portfolio and bring them to the market faster.
Built on collaboration
Our partnerships are built on an equitable sharing of profits and a clear separation of IP. Our development partners own all rights and regulatory filing for an assay, which gives you control over branding for all test kits, including cartridges. We retain ownership of the analyzer and FluxergyWorks.
Reimagining the OEM workflow
See the difference Fluxergy can make to improve your OEM workflow.
1
Develop Assay on 96 well plate
2
Develop hardware to replicate assay process
3
Test assay in R&D hardware configuration
4
Adjust hardware to make assay work
5
Complete R&D with working R&D assay and hardware configuration
6
Evaluate hardware and assay changes to allow for cost down/ supply chain
7
Test assay and hardware changes
8
Evaluate hardware and assay changes for manufacturability (automation, IPQC's, etc.)
9
Test assay and hardware changes
10
Create Pilot Production line
11
Create and test pilot production lots to evaluate production line (IQQQPQ)
12
Evaluate pilot lot performance per R&D performance
13
Run Verification and Validation
14
Run Clinical Trial
15
Commercialize
1
Develop Assay on 96 well plate
2
Develop hardware to replicate assay process
3
Test assay in R&D hardware configuration
4
Adjust hardware to make assay work
5
Complete R&D with working R&D assay and hardware configuration
6
Evaluate hardware and assay changes to allow for cost down/ supply chain
7
Test assay and hardware changes
8
Evaluate hardware and assay changes for manufacturability (automation, IPQC's, etc.)
9
Test assay and hardware changes
10
Create Pilot Production line
11
Create and test pilot production lots to evaluate production line (IQQQPQ)
12
Evaluate pilot lot performance per R&D performance
13
Run Verification and Validation
14
Run Clinical Trial
15
Commercialize
Multimodal testing
Overview
Fluxergy has developed a multi-modal diagnostic platform which enables the transfer of assays from the laboratory to the point of care setting.
This includes molecular testing (e.g., PCR), immunoassays, cytometry assays and chemistry assays all within a single instrument.
The automated, sample-to-answer workflows can be customized for specific sample and testing methods, and partners can easily develop assays on the system to rapidly bring to the point-of-care using Fluxergy's open platform concept combined with flexible software and hardware manufacturing.
Molecular
Design, develop, and deliver Molecular assays on the Fluxergy Platform.
Develop a multiplex molecular nucleic acid detection panel on an open, cost-effective POC Platform.
Technology Capabilities:
- Multiplex PCR, RT-PCR, isothermal
Features:
- 6 individually temperature-controlled PCR reactions
- Can house probe or intercalating dyes in 2 fluorescent channels
- Add lyophilization-compatible reagents directly onto the cartridge
- On card - Pre-cycling, mixing, and thermal lysis capabilities
Analysis Features:
- Qualitative and quantitative: Look at PCR fluorescence data on a POC machine
- Individual Cycle threshold (CT) readings and melt curve analysis
Where are we going
- 12+ target multiplex panels
Immunochemistry (LFA)
Deliver POC Immunoassays to address mass screening applications
Capable of housing quantitative immunoassay technologies for detection of protein and chemical analytes.
Technology capabilities: Fluorescent and visual lateral flow immunoassays (LFA), liquid-based immunoassays
Features:
- Multiplex, multi-sample type assays
- Built to read standard lateral flow strips
- Visual and fluorescent readout capabilities
- Read peak intensities of various concentrations at multiple points in the strip
Where are we going?
- Multiplex, multi-sample type assays
Chemistry
Detect Small Molecules with a flexible sensor system.
Read visual dry chemistry assays on a flexible cartridge to enable common biomarker and small molecule detection.
Technology Capabilities: dry-chemistry, dipstick chemistry, microfluidic chemistry assays
Features:
- Utilize colorimetric chemistry assays
- Visual/Fluorescent readout capabilites
- Electrochemical sensor capability
Where are we going:
- Building a CMP and BMP using electrochemical biosensor technology
Cytometry
Counting cells to characterizing morphology
Technological capabilities: fluorescence and visual-based image cytometry
Features:
- Design custom algorithms for unlimited counting applications
- Adaptable to reading pathology slides
- Capture fluorescently died artifacts and morphological structures
Example Application: Fluxergy's white blood cell count cartridge
Featured assays
Streptococcus equi ssp. equi -PCR Fluxergy Assay*
HVRe Influenza / RSV / SARS-CoV-2 Respiratory Panel
COVID-19 PCR Test Kit
Environmental Salmonella -PCR Fluxergy Test Kit
Resource Center
Explore Fluxergy's information hub with webinars, product materials, how-to-videos, and more.
"Fluxergy's technology has a great potential to start a new era in the diagnostic field. Fluxergy's portable, user-friendly, and cost-effective PCR technology provides highly accurate results in less than an hour, which is needed to control the spread of infectious diseases."
Dr. Lucjan Witkowski
Warsaw University of Life Sciences
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