Arrayit Corporation (ARYC)

[MikeCr]

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.

ImmunoCAP ISAC is an immunoassay platform that allows for simultaneous measurement of specific IgE antibodies to 112 different allergen components using only 30 µl of serum or plasma. Capillary blood sampling can be used, thus enabling a less invasive procedure for testing young children.

Arrayit allergy tests utilize non-invasive and convenient finger stick sampling and blood card collection, in conjunction with patented and proprietary protein microarray technology, to rapidly and accurately measure immunoglobulin E (IgE) antibodies in the human bloodstream produced by exposure to 120 common food and environmental allergens.