COVID-19 Point of Care Diagnostic Test Platform
Invetech rapidly delivered a COVID-19 Point of Care molecular diagnostic test platform ready for large-volume production in a matter of months, using an MVP strategy to optimize time-to-market
Client: Life science startup focused on rapid, point-of-need solutions
Product: Rapid Point of Care (POC) molecular diagnostic platform designed for CLIA Waiver
Rapidly responding to the critical need for COVID-19 testing
In response to the SARS-CoV-2 virus and demand for diagnostic testing, the United States Food and Drug Administration (FDA) called for accelerated development of COVID-19 healthcare solutions and expanded national testing capacity. Under the FDA emergency use authorization (EUA) directive, our client set out to develop a rapid, molecular diagnostic test for the identification of the SARS-CoV-2 virus that was able to be run by non-medical personnel.
After receiving funding from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative, they engaged Invetech to rapidly convert a manually performed chemistry to an automated consumable-plus-instrument platform that could be used in Clinical Laboratory Improvement Amendments (CLIA)-Waived settings.
The objective was to get to market as rapidly as possible with a fully functioning platform to help address the critical need for diagnostic testing. As part of the product development strategy, design
optimization was intentionally deferred to accelerate the delivery on a Minimum Viable Product (MVP).
In under six months, we needed to:
- Establish the platform architecture and define product requirements through transfer to manufacturing
- Address key technical risks associated with integrating an existing mature sample prep protocol and consumable into an integrated POC cartridge
- Arrive at a Minimum Viable Product (MVP) device that met core requirements and was both simple to use and able to scale in production
- Build an instrument that could be scaled effectively to be manufactured in large volumes, shipping at a rate of thousands per month
Life Sciences & Biotech
Not all innovative or complex technology is used in the clinic, but these systems benefit from many of the same principles used.
Mid to High Throughput Instruments
Whether we support the entire product or take lead on a subsystem, full instrument architecture is critical to success.
Benchtop & Distributed
Translating technical workflows of an assay into an automated process performed within a device.
Custom Process Automation
Transition from clinical to commercial scale manufacturing with our production-ready manufacturing and automation solutions.