MFLUIDX

mFluiDx operates at the intersection of microfluidics and molecular diagnostics, spun out of the University of California, Berkeley in 2015. The company was co-founded by CEO Charlie Yeh and CSO Danica Helb. Yeh’s foundation for the company stems from his joint PhD in Bioengineering from UCSF/UC Berkeley, where his thesis on point-of-care microfluidic diagnostics led to the development of the core technology. His drive to translate scientific research directly into practical applications was fueled by personal experiences with misdiagnosis and extensive market validation, which included over 200 interviews across multiple countries.

The company is focused on developing rapid, low-cost, point-of-care molecular diagnostics for infectious diseases. Its target clients are small clinics, pharmacies, and other decentralized healthcare settings that traditionally rely on slower, more expensive, or less sensitive diagnostic methods. mFluiDx addresses a market need for diagnostic tools that bridge the gap between inexpensive but less sensitive rapid antigen tests and highly sensitive but costly and slow laboratory-based PCR tests.

The core product is the "SIMPLE CHIP," a microfluidic chip designed for automated, on-site DNA/RNA detection. This technology uses isothermal nucleic acid amplification, providing performance comparable to PCR but at a significantly lower cost. The chip's design allows for the detection of multiple pathogens from a single sample in 7 to 15 minutes. A key feature is its operation without external power; the chip is activated by opening a vacuum pouch and uses a reusable heat pack for the amplification process. Results can be read using a smartphone, which also enables the platform to integrate GPS data and test results into a cloud system for disease tracking and public health resource management. The manufacturing process, involving injection molding, is intended to make the consumable cartridges extremely low-cost.

mFluiDx's initial funding included a seed round of $250K from IndieBio in March 2016. The company has also secured significant grant funding, including a $1.8M grant from the Department of Health and Human Services (HHS) in June 2018 and funding from the Gates Foundation. It has participated in accelerators like IndieBio and the CITRIS Foundry and received SBIR grants from the NIH.

Keywords: point-of-care diagnostics, microfluidics, molecular diagnostics, infectious disease testing, DNA/RNA detection, isothermal amplification, UC Berkeley spinout, decentralized healthcare, low-cost diagnostics, rapid testing, SIMPLE CHIP, diagnostic assay, sample-to-answer, smartphone diagnostics, public health surveillance, medical device, biotech, life science accelerator, SBIR grant recipient, Gates Foundation funded