In subsequent posts, I noted that the Thermofisher microarray multiplex test is not FDA approved yet. They have FDA approval for simplex tests of one allergen at a time.
How Arrayit's allergy test is beating ThermoFisher's test in the U.S market
Thermofisher has a multiplex microarray allergy test, ImmunoCAP® ISAC 112, that only needs one drop of blood. But it's not FDA approved. They do have FDA approved singleplex tests for one allergen at a time.. Thermofisher doesn't process their own tests. Other labs like Quest and Labcorp sell the Thermofisher tests. But Quest and Labcorp can't sell the ImmunoCAP® ISAC 112 in the U.S because it's not FDA approved. ImmunoCAP® ISAC 112 is being sold in Europe and other parts of the world.
Arrayit can get around the FDA restriction in the U.S because Arrayit is processing its own test as an LDT (laboratory developed test) and not selling it through other labs. The proficiency testing that the test has passed has allowed coverage form Medicare, Medicaid and private insurance. Arrayit has had to build its own processing/payment systems and this is causing growing pains. Unlike Quest and Labcorp and other labs that have mature systems to do this.
Arrayit's allergy test is getting market penetration ahead of the Thermofisher ImmunoCAP® ISAC 112 FDA approval, and of Arrayit's own test FDA approval.