Improving Public Health with Affordable Disease Tests

In 2018, diagnostics maker Quidel® entered the exploding Over-the-counter market for at-home testing for illnesses like the flu and Lyme disease. Without warning, in early 2020, COVID-19 spread like wildfire, escalating the critical need for tests. The diagnostic manufacturer entered the consumer health market as its rapid flu test advanced to pilot production. The existing design had limitations including limited software updates to read new strains, cartridges, etc.

Early concept through final regulatory stages:

• Concept designs, design for an alpha, test equipment and production ramp-up, testing, regulatory documents, etc.

Develop a miniature fluorescence reader compatible with existing disposable design

• Bluetooth connectivity
• Image capture & analysis
• Mobile app

Design for manufacturability, cost, etc. (DFM&A)

• Design for use with varying cartridges – accommodate various sized cartridges and diminish ambient light

Advance from proof-of-concept to pre-pilot manufacturing

Boston Engineering built the product development kit in just 15 months, empowering Quidel to:

• Win emergency authorization use from the FDA for COVID-19 for its QuickVue® test
• Manufacture a successful, initial run of 100,000 sample cassettes in February, 2021

Emergency use authorization (EUA) approval.

• This device will provide accurate test results in as little as 10 minutes
• Saves thousands of lives