The VereChip™ is a Lab-on-Chip developed, manufactured, and supplied exclusively by STMicroelectronics (NYSE: STM). ST has 12 main manufacturing sites around the world: 6 which perform wafer fabrication and 6 which perform assembly, packaging, and test. The Lab-on-Chip supply chain is ISO 13485 compliant and includes: wafer fabrication; dicing, assembly, and test; surface chemistry and spotting; quality control; and packaging, labeling, and shipping.
The wafers are manufactured in ST’s state of the art Micro-Electro Mechanical Systems (MEMS) manufacturing facility. ST is the worldwide leader in MEMS and the Lab-on-Chip is manufactured leveraging off of the high volume, low cost manufacturing line. The wafers go through a testing step where each die is calibrated to ensure a very rigid temperature control for the final user.
The wafers are then diced into individual chips and assembled on a 3” x 1” printed circuit board in ST’s main MEMS assembly plant in a dedicated area for medical products. The assembled chips go through an electrical test and are ready for biochemical processing.
The surface chemistry and spotting is performed in a dedicated class 100 clean room with temperature and humidity control. The proprietary surface chemistry enables biocompatibility for efficient amplification and hybridization and was developed using standard semiconductor manufacturing equipment for high throughput manufacturing. The proprietary equipment used for spotting were developed using 6-sigma methodology and includes on-the fly spotting with error detection. The equipment are engineered with the concept of high throughput, low cost semiconductor manufacturing.
Combining molecular biology, biochemistry, and world class semiconductor manufacturing concepts such as risk assessment, statistical design of experiments (DOE), problem solving and continuous improvement puts Veredus in a position to bring excellent multiplexed molecular testing products to the market.