About Applied Microarrays
Foundations & Business Model
Applied Microarrays (“AMI”) was founded in 2006 by CEO Alastair Malcolm, with the business model of manufacturing Point-of-Care and High Throughput DNA and protein arrays whose custom bio-content is developed by AMI’s customers.
AMI acquired the microarray assets of GE Healthcare in 2007, and hired their key talent who had developed arrays for whole genome expression arrays, SNP ‘s, microRNA’s and immunoassays. The array manufacturing equipment from GE has unique features enabling quality, accuracy and repeatability not available in tools sold on the general market.
Quality Philosophy & Systems
AMI’s entire team has been trained in Six Sigma characterization and control techniques, and applies those tools in driving optimum performance and repeatable manufacturing of our customers’ products.
AMI’s approach is that more regulations will be implemented going forward to multiplex diagnostic devices. Accordingly we treat our customer engagements with quality systems that will enable their products to be accepted successfully in regulated markets.
AMI’s Quality Policy is very simple and focused, directed towards “Three C”’s:
- Continuous Improvement
ISO 9001 and 13485
AMI adapted GE’s quality systems to the new business model, and has operated continuously under ISO 9001 and 13485.
Certificates, available for download: ISO 9001 Certification | ISO 13485 Certification
AMI’s headquarter is in Tempe, Arizona, in a semiconductor and flat panel display cleanroom originally constructed and operated by Motorola. The central services for clean air, water, gases, waste disposal and environmental controls are world-class and a key contributor to our consistent manufacturing.
AMI is establishing a second site in Singapore to meet growing demands of the Asian market, and to support burst upside demand anticipated by several of our contract customers launching new Point-of-Care and CLIA Lab products in the near future.