Astoria-Pacific, Inc. (API), was established in 1990 by Raymond Pavitt in Clackamas, Oregon. In 1994, API pioneered standardization of newborn screening with its receipt of the first US FDA clearance for phenylalanine and total galactose kits. Since then, the Company has continually invested in bringing innovations to advance the testing capabilities and meet the growing workflow needs of newborn screening laboratories.
Today, API is proud to partner with newborn screening programs worldwide, providing its SPOTCHECK® brand of in vitro diagnostic instrumentation, reagent kits and reference materials under an ISO 13485 certified quality management system. The company’s longevity is a testament to its commitment to providing time critical, personalized service and support to ensure that newborn screening laboratory customers are able to report quality results everyday.
Historical View of Astoria Pacific in Newborn Screening
|SPOTCHECK® Pro and Pro-Plex Service Agreement Overview|
|Astoria-Pacific was granted the first US FDA-cleared high-throughput newborn screening tests for Phenylalanine (PKU) and Total Galactose (GALT) tests in 1994.|
|In 1997, API was granted US FDA clearance for the SPOTCHECK Uridyltransferase Reagent Kit (GALT).|
|In 1999, API was granted US FDA clearance for the SPOTCHECK G6PD Kit, the first high-throughput FDA-cleared assay for G6PD deficiency.|
|In 2001, API was granted US FDA clearance for the SPOTCHECK Biotinidase Kit, the first FDA-cleared assay for biotinidase deficiency.|
|In 2008, API followed up with the first US FDA-cleared, fully-automated test for biotinidase deficiency with the SPOTCHECK Biotinidase Microplate Kit.|
|In 2013, API was granted US FDA clearance for the first fully-automated test for total galactose with the SPOTCHECK Neonatal Total Galactose Microplate Kit.|